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Oral Irritation Study of Two Experimental Mouthrinses

Sponsor
Johnson & Johnson Consumer and Personal Products Worldwide (Industry)
Overall Status
Completed
CT.gov ID
NCT01156376
Collaborator
(none)
80
Enrollment
1
Location
3
Arms
30
Duration (Days)
81.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is 25 days long. People participating in this study will be asked to brush their teeth two times a day. People will be assigned to a mouthwash and will rinse four times a day at the site for five days. A dentist or dental hygienist will look at the mouth, teeth, tongue and gums to make sure the mouthwash does not irritate the mouth. After Day 5 of the study, people will continue to brush two times a day and will return on Day 24 to have their mouth looked at again. People without irritation in their mouth will rinse 4 times a day at the clinical site. People will return to the clinical site the next day and have a final oral exam in which the dentist or dental hygienist will look at the mouth for irritation.

Condition or Disease Intervention/Treatment Phase
  • Device: Potassium Oxalate without Fluoride
  • Device: Potassium Oxalate with Fluoride
  • Device: Active Comparator PO-116-A
 N/A

Detailed Description

This is a randomized, observer-blind, single-center, supervised, controlled, parallel-designed study. Approximately 90 generally healthy adults meeting the necessary inclusion/exclusion criteria will be enrolled so that 78 subjects (26 per treatment group) would reasonably be expected to complete the study. Subjects will have their oral soft/hard tissues assessed at Screening (visit 1), Baseline (visit 2), and Days 3, 5, 24, and 25 (visits 4,6-8). During the first week of the study, subjects will be instructed to brush their teeth for one minute in their usual manner, twice daily using the provided standard fluoride toothpaste. Subjects will return for the Baseline exam and, upon qualification with entry criteria, will be assigned to one of three treatment groups. Qualified subjects will be instructed to return to the site for five consecutive days. Subjects will have four supervised rinses with their assigned mouth rinse for either 30 or 60 seconds using 10 ml or 20 ml, at subsequent one-hour intervals. During the 5 consecutive days of exposure to the assigned mouthrinse, subjects will brush their teeth using the provided fluoride-free toothpaste and soft-bristled toothbrush.

Subjects will then have an 18-day rest period (off treatment). During this time, subjects will follow their usual oral hygiene and dietary habits, using the standard fluoride toothpaste and soft toothbrush provided, and must refrain from using any unassigned oral care products. On the 19th day after completion of Day 5 (Day 24), subjects will return for an oral examination. If no pathology is present, subjects will be given a challenge treatment (four supervised rinses) and the final oral examination will be performed on Day 25.

Study Design

Study Type:
Interventional
Actual Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Basic Science
Official Title:
Determination of the Oral Irritation and Sensitization Potential of Two Experimental Potassium Oxalate Containing Mouthrinses
Study Start Date :
Jun 1, 2010
Actual Primary Completion Date :
Jul 1, 2010
Actual Study Completion Date :
Jul 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Experimental: PO-019

Formula 12027-019 Mouthwash

Device: Potassium Oxalate without Fluoride
1.40% Potassium Oxalate Sensitive Mouthwash without fluoride - Rinse with 10ml for 60 seconds, four times daily successively at 1 hour intervals for five days
Other Names:
  • Formula 12027-019

    		•
    Experimental: PO-020

    Formula 12027-020 Mouthwash

    Device: Potassium Oxalate with Fluoride
    1.40% Potassium Oxalate Sensitive Mouthwash with fluoride - Rinse with 20ml for 60 seconds, four times daily successively at 1 hour intervals for five days
    Other Names:
  • Formula 12027-020

    		•
    Active Comparator: PO-116-A

    Cool Mint Listerine

    Device: Active Comparator PO-116-A
    Rinse with comparator mouthwash 20ml for 30 seconds, four times daily successively at 1 hour intervals for five days
    Other Names:
  • Cool Mint Listerine

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of Participants With an Abnormal Condition by Anatomical Site at Screening [Screening]

      Buccal, labial and sublingual mucosae, mucobuccal fold, gingiva, tongue, hard and soft palate, uvula, oropharynx, teeth and dental restorations were examined. The dental examiner evaluated any condition as either normal or abnormal.

    2. Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 1 - Baseline/Pretreatment [Day 1 - Baseline/Pretreatment]

      Buccal, labial and sublingual mucosae, mucobuccal fold, gingiva, tongue, hard and soft palate, uvula, oropharynx, teeth and dental restorations were examined. The dental examiner evaluated any condition as either normal or abnormal.

    3. Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 1 - Post-treatment [Day 1 - Post-treatment]

      Buccal, labial and sublingual mucosae, mucobuccal fold, gingiva, tongue, hard and soft palate, uvula, oropharynx, teeth and dental restorations were examined. The dental examiner evaluated any condition as either normal or abnormal.

    4. Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 3 [Day 3]

      Buccal, labial and sublingual mucosae, mucobuccal fold, gingiva, tongue, hard and soft palate, uvula, oropharynx, teeth and dental restorations were examined. The dental examiner evaluated any condition as either normal or abnormal.

    5. Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 5 [Day 5]

      Buccal, labial and sublingual mucosae, mucobuccal fold, gingiva, tongue, hard and soft palate, uvula, oropharynx, teeth and dental restorations were examined. The dental examiner evaluated any condition as either normal or abnormal.

    6. Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 24 - Pretreatment [Day 24 - Pretreatment]

      Buccal, labial and sublingual mucosae, mucobuccal fold, gingiva, tongue, hard and soft palate, uvula, oropharynx, teeth and dental restorations were examined. The dental examiner evaluated any condition as either normal or abnormal.

    7. Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 24 - Post-treatment [Day 24 - Post-treatment]

      Buccal, labial and sublingual mucosae, mucobuccal fold, gingiva, tongue, hard and soft palate, uvula, oropharynx, teeth and dental restorations were examined. The dental examiner evaluated any condition as either normal or abnormal.

    8. Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 25 [Day 25]

      Buccal, labial and sublingual mucosae, mucobuccal fold, gingiva, tongue, hard and soft palate, uvula, oropharynx, teeth and dental restorations were examined. The dental examiner evaluated any condition as either normal or abnormal.

    9. Percentage of Subjects in Irritation Score Category for Buccal Mucosa at Screening [Screening]

      The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

    10. Percentage of Subjects in Irritation Score Category for Labial Mucosa at Screening [Screening]

      The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

    11. Percentage of Subjects in Irritation Score Category for Sublingual Mucosa at Screening [Screening]

      The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

    12. Percentage of Subjects in Irritation Score Category for Mucobuccal Fold at Screening [Screening]

      The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

    13. Percentage of Subjects in Irritation Score Category for Gingiva at Screening [Screening]

      The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

    14. Percentage of Subjects in Irritation Score Category for Tongue at Screening [Screening]

      The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

    15. Percentage of Subjects in Irritation Score Category for Hard/Soft Palate at Screening [Screening]

      The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

    16. Percentage of Subjects in Irritation Score Category for Uvula/Oropharynx at Screening [Screening]

      The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

    17. Percentage of Subjects in Irritation Score Category for Buccal Mucosa at Day 1 - Baseline/Pretreatment [Day 1 - Baseline/Pretreatment]

      The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

    18. Percentage of Subjects in Irritation Score Category for Labial Mucosa at Day 1 - Baseline/Pretreatment [Day 1 - Baseline/Pretreatment]

      The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

    19. Percentage of Subjects in Irritation Score Category for Sublingual Mucosa at Day 1 - Baseline/Pretreatment [Day 1 - Baseline/Pretreatment]

      The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

    20. Percentage of Subjects in Irritation Score Category for Mucobuccal Fold at Day 1 - Baseline/Pretreatment [Day 1 - Baseline/Pretreatment]

      The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

    21. Percentage of Subjects in Irritation Score Category for Gingiva at Day 1 - Baseline/Pretreatment [Day 1 - Baseline/Pretreatment]

      The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

    22. Percentage of Subjects in Irritation Score Category for Tongue at Day 1 - Baseline/Pretreatment [Day 1 - Baseline/Pretreatment]

      The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

    23. Percentage of Subjects in Irritation Score Category for Hard/Soft Palate at Day 1 - Baseline/Pretreatment [Day 1 - Baseline/Pretreatment]

      The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

    24. Percentage of Subjects in Irritation Score Category for Uvula/Oropharynx at Day 1 - Baseline/Pretreatment [Day 1 - Baseline/Pretreatment]

      The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

    25. Percentage of Subjects in Irritation Score Category for Buccal Mucosa at Day 1 - Post-treatment [Day 1 - Post-treatment]

      The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

    26. Percentage of Subjects in Irritation Score Category for Labial Mucosa at Day 1 - Post-treatment [Day 1 - Post-treatment]

      The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

    27. Percentage of Subjects in Irritation Score Category for Sublingual Mucosa at Day 1 - Post-treatment [Day 1 - Post-treatment]

      The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

    28. Percentage of Subjects in Irritation Score Category for Mucobuccal Fold at Day 1 - Post-treatment [Day 1 - Post-treatment]

      The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

    29. Percentage of Subjects in Irritation Score Category for Gingiva at Day 1 - Post-treatment [Day 1 - Post-treatment]

      The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

    30. Percentage of Subjects in Irritation Score Category for Tongue at Day 1 - Post-treatment [Day 1 - Post-treatment]

      The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

    31. Percentage of Subjects in Irritation Score Category for Hard/Soft Palate at Day 1 - Post-treatment [Day 1 - Post-treatment]

      The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

    32. Percentage of Subjects in Irritation Score Category for Uvula/Oropharynx at Day 1 - Post-treatment [Day 1 - Post-treatment]

      The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

    33. Percentage of Subjects in Irritation Score Category for Buccal Mucosa at Day 3 [Day 3]

      The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

    34. Percentage of Subjects in Irritation Score Category for Labial Mucosa at Day 3 [Day 3]

      The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

    35. Percentage of Subjects in Irritation Score Category for Sublingual Mucosa at Day 3 [Day 3]

      The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

    36. Percentage of Subjects in Irritation Score Category for Mucobuccal Fold at Day 3 [Day 3]

      The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

    37. Percentage of Subjects in Irritation Score Category for Gingiva at Day 3 [Day 3]

      The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

    38. Percentage of Subjects in Irritation Score Category for Tongue at Day 3 [Day 3]

      The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

    39. Percentage of Subjects in Irritation Score Category for Hard/Soft Palate at Day 3 [Day 3]

      The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

    40. Percentage of Subjects in Irritation Score Category for Uvula/Oropharynx at Day 3 [Day 3]

      The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

    41. Percentage of Subjects in Irritation Score Category for Buccal Mucosa at Day 5 [Day 5]

      The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

    42. Percentage of Subjects in Irritation Score Category for Labial Mucosa at Day 5 [Day 5]

      The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

    43. Percentage of Subjects in Irritation Score Category for Sublingual Mucosa at Day 5 [Day 5]

      The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

    44. Percentage of Subjects in Irritation Score Category for Mucobuccal Fold at Day 5 [Day 5]

      The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

    45. Percentage of Subjects in Irritation Score Category for Gingiva at Day 5 [Day 5]

      The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

    46. Percentage of Subjects in Irritation Score Category for Tongue at Day 5 [Day 5]

      The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

    47. Percentage of Subjects in Irritation Score Category for Hard/Soft Palate at Day 5 [Day 5]

      The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

    48. Percentage of Subjects in Irritation Score Category for Uvula/Oropharynx at Day 5 [Day 5]

      The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

    49. Percentage of Subjects in Irritation Score Category for Buccal Mucosa at Day 24 - Pretreatment [Day 24 - Pretreatment]

      The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

    50. Percentage of Subjects in Irritation Score Category for Labial Mucosa at Day 24 - Pretreatment [Day 24 - Pretreatment]

      The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

    51. Percentage of Subjects in Irritation Score Category for Sublingual Mucosa at Day 24 - Pretreatment [Day 24 - Pretreatment]

      The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

    52. Percentage of Subjects in Irritation Score Category for Mucobuccal Fold at Day 24 - Pretreatment [Day 24 - Pretreatment]

      The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

    53. Percentage of Subjects in Irritation Score Category for Gingiva at Day 24 - Pretreatment [Day 24 - Pretreatment]

      The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

    54. Percentage of Subjects in Irritation Score Category for Tongue at Day 24 - Pretreatment [Day 24 - Pretreatment]

      The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

    55. Percentage of Subjects in Irritation Score Category for Hard/Soft Palate at Day 24 - Pretreatment [Day 24 - Pretreatment]

      The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

    56. Percentage of Subjects in Irritation Score Category for Uvula/Oropharynx at Day 24 - Pretreatment [Day 24 - Pretreatment]

      The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

    57. Percentage of Subjects in Irritation Score Category for Buccal Mucosa at Day 24 - Post-treatment [Day 24 - Post-treatment]

      The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

    58. Percentage of Subjects in Irritation Score Category for Labial Mucosa at Day 24 - Post-treatment [Day 24 - Post-treatment]

      The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

    59. Percentage of Subjects in Irritation Score Category for Sublingual Mucosa at Day 24 - Post-treatment [Day 24 - Post-treatment]

      The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

    60. Percentage of Subjects in Irritation Score Category for Mucobuccal Fold at Day 24 - Post-treatment [Day 24 - Post-treatment]

      The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

    61. Percentage of Subjects in Irritation Score Category for Gingiva at Day 24 - Post-treatment [Day 24 - Post-treatment]

      The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

    62. Percentage of Subjects in Irritation Score Category for Tongue at Day 24 - Post-treatment [Day 24 - Post-treatment]

      The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

    63. Percentage of Subjects in Irritation Score Category for Hard/Soft Palate at Day 24 - Post-treatment [Day 24 - Post-treatment]

      The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

    64. Percentage of Subjects in Irritation Score Category for Uvula/Oropharynx at Day 24 - Post-treatment [Day 24 - Post-treatment]

      The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

    65. Percentage of Subjects in Irritation Score Category for Buccal Mucosa at Day 25 [Day 25]

      The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

    66. Percentage of Subjects in Irritation Score Category for Labial Mucosa at Day 25 [Day 25]

      The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

    67. Percentage of Subjects in Irritation Score Category for Sublingual Mucosa at Day 25 [Day 25]

      The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

    68. Percentage of Subjects in Irritation Score Category for Mucobuccal Fold at Day 25 [Day 25]

      The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

    69. Percentage of Subjects in Irritation Score Category for Gingiva at Day 25 [Day 25]

      The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

    70. Percentage of Subjects in Irritation Score Category for Tongue at Day 25 [Day 25]

      The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

    71. Percentage of Subjects in Irritation Score Category for Hard/Soft Palate at Day 25 [Day 25]

      The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

    72. Percentage of Subjects in Irritation Score Category for Uvula/Oropharynx at Day 25 [Day 25]

      The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Males and females at least 18 years of age in good general and oral health without any known allergy to commercial dental products or cosmetics.

    • Evidence of a personally signed and dated informed consent document indicating the subject (or legally acceptable representative) has been informed of all pertinent aspects of the trial.

    • Willingness to use the assigned products according to instructions, availability for appointments, and likelihood of completing the clinical trial.

    • Willingness to refrain from using any breath freshener products (e.g., oral care strips, candy-type mints, sprays, chewing gums, throat lozenges, cough drops or mouthwashes), whitening products and smokeless tobacco products within one week prior to and for the duration of the study, in order to reduce alternate sources of potential irritation and sensitization.

    • A minimum of 20 natural teeth.

    • Absence of abnormal or severe fissured tongue, geographic tongue, or any obvious tongue abnormalities that may interfere with the assessment of oral irritation.

    • Adequate oral hygiene (i.e., brush teeth daily & exhibit no signs of oral neglect).

    • Absence of neglected dental health (i.e., gross calculus deposits or rampant caries based on visual examination), significant oral soft tissue pathology, systematically-related gingival enlargement or tissue damage due to ill-fitting appliances or restoration.

    • Absence of orthodontic bands, appliances, bridges, extensive large restorations or removable orthodontic appliances.

    Exclusion Criteria:

    • Volunteers who report history or presence of kidney disorders or kidney stones, Crohn's Disease or other malabsorption syndromes.

    • History of significant adverse effects following use of oral hygiene products such as toothpastes and mouthwashes.

    • Physical limitations or restrictions that might preclude use of normal oral hygiene procedures (i.e., toothbrushing, mouthrinsing, etc.).

    • History or current evidence of significant oral soft tissue pathology, excluding gingivitis, based on the dentist's visual examination and at the discretion of the investigator.

    • Those requiring antibiotic premedication prior to dental treatment.

    • Participation in a dental clinical trial involving oral care products within the past 30 days.

    • Visual evidence of Moderate/Advanced Periodontitis (ADA Type III, IV).

    • Women who are pregnant, nursing or plan to become pregnant during the course of the study.

    • Volunteers requiring treatment with Indinavir or loop diuretics (i.e., Furosemide).

    • Other severe, acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or may interfere with the interpretation of trial result and, in the judgment of the investigator, would make the subject inappropriate for entry into this trial

    • Any clinical history which in the opinion of the investigator could compromise the safety of the subject or the clinical parameters being assessed

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Park Research Center (UPRC) Fort Wayne Indiana United States 46825

    Sponsors and Collaborators

    • Johnson & Johnson Consumer and Personal Products Worldwide

    Investigators

    • Study Director: Michael Lynch, DMD, PhD, Johnson & Johnson Consumer and Personal Products Worldwide

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Johnson & Johnson Consumer and Personal Products Worldwide
    ClinicalTrials.gov Identifier:
    NCT01156376
    Other Study ID Numbers:
    • KOXDHY0003
    First Posted:
    Jul 2, 2010
    Last Update Posted:
    Aug 24, 2015
    Last Verified:
    Aug 1, 2015
    Additional relevant MeSH terms:
    Oral Manifestations
    Listerine
    Fluorides

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title 19292-116-A Control (Listerine®) 12027-019 12027-020
    Arm/Group Description Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL) 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
    Period Title: Overall Study
    STARTED 27 26 27
    COMPLETED 26 26 23
    NOT COMPLETED 1 0 4

    Baseline Characteristics

    Arm/Group Title 19292-116-A Control (Listerine®) 12027-019 12027-020 Total
    Arm/Group Description Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL) 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL) Total of all reporting groups
    Overall Participants 27 26 27 80
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    48.4
    (14.24)
    37.6
    (14.29)
    51.0
    (15.03)
    45.8
    (15.47)
    Sex: Female, Male (Count of Participants)
    Female
    20
    74.1%
    15
    57.7%
    22
    81.5%
    57
    71.3%
    Male
    7
    25.9%
    11
    42.3%
    5
    18.5%
    23
    28.8%
    Region of Enrollment (participants) [Number]
    USA
    27
    100%
    26
    100%
    27
    100%
    80
    100%

    Outcome Measures

    1. Primary Outcome
    Title Percentage of Participants With an Abnormal Condition by Anatomical Site at Screening
    Description Buccal, labial and sublingual mucosae, mucobuccal fold, gingiva, tongue, hard and soft palate, uvula, oropharynx, teeth and dental restorations were examined. The dental examiner evaluated any condition as either normal or abnormal.
    Time Frame Screening

    Outcome Measure Data

    Analysis Population Description
    Analysis was based on subjects with measurements for this variable.
    Arm/Group Title 19292-116-A Control (Listerine®) 12027-019 12027-020
    Arm/Group Description Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL) 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
    Measure Participants 27 26 27
    Buccal Mucosa
    0
    0%
    0
    0%
    0
    0%
    Labial Mucosa
    0
    0%
    0
    0%
    0
    0%
    Sublingual Mucosa
    0
    0%
    0
    0%
    0
    0%
    Mucobuccal Fold
    0
    0%
    3.8
    14.6%
    0
    0%
    Gingiva
    0
    0%
    0
    0%
    3.7
    13.7%
    Tongue
    0
    0%
    3.8
    14.6%
    3.7
    13.7%
    Hard/Soft Palate
    0
    0%
    0
    0%
    0
    0%
    Uvula/Oropharynx
    0
    0%
    0
    0%
    0
    0%
    Teeth
    0
    0%
    0
    0%
    0
    0%
    Dental Restorations
    0
    0%
    0
    0%
    0
    0%
    2. Primary Outcome
    Title Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 1 - Baseline/Pretreatment
    Description Buccal, labial and sublingual mucosae, mucobuccal fold, gingiva, tongue, hard and soft palate, uvula, oropharynx, teeth and dental restorations were examined. The dental examiner evaluated any condition as either normal or abnormal.
    Time Frame Day 1 - Baseline/Pretreatment

    Outcome Measure Data

    Analysis Population Description
    Analysis was based on subjects with measurements for this variable.
    Arm/Group Title 19292-116-A Control (Listerine®) 12027-019 12027-020
    Arm/Group Description Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL) 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
    Measure Participants 27 26 27
    Buccal Mucosa
    0
    0%
    0
    0%
    0
    0%
    Labial Mucosa
    0
    0%
    0
    0%
    0
    0%
    Sublingual Mucosa
    0
    0%
    0
    0%
    0
    0%
    Mucobuccal Fold
    0
    0%
    0
    0%
    0
    0%
    Gingiva
    0
    0%
    0
    0%
    0
    0%
    Tongue
    3.7
    13.7%
    0
    0%
    3.7
    13.7%
    Hard/Soft Palate
    0
    0%
    0
    0%
    0
    0%
    Uvula/Oropharynx
    0
    0%
    0
    0%
    0
    0%
    Teeth
    0
    0%
    0
    0%
    0
    0%
    Dental Restorations
    0
    0%
    0
    0%
    0
    0%
    3. Primary Outcome
    Title Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 1 - Post-treatment
    Description Buccal, labial and sublingual mucosae, mucobuccal fold, gingiva, tongue, hard and soft palate, uvula, oropharynx, teeth and dental restorations were examined. The dental examiner evaluated any condition as either normal or abnormal.
    Time Frame Day 1 - Post-treatment

    Outcome Measure Data

    Analysis Population Description
    Analysis was based on subjects with measurements for this variable.
    Arm/Group Title 19292-116-A Control (Listerine®) 12027-019 12027-020
    Arm/Group Description Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL) 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
    Measure Participants 27 26 26
    Buccal Mucosa
    0
    0%
    0
    0%
    3.8
    14.1%
    Labial Mucosa
    0
    0%
    0
    0%
    0
    0%
    Sublingual Mucosa
    0
    0%
    0
    0%
    0
    0%
    Mucobuccal Fold
    0
    0%
    0
    0%
    0
    0%
    Gingiva
    0
    0%
    0
    0%
    0
    0%
    Tongue
    18.5
    68.5%
    0
    0%
    7.7
    28.5%
    Hard/Soft Palate
    0
    0%
    0
    0%
    0
    0%
    Uvula/Oropharynx
    0
    0%
    0
    0%
    0
    0%
    Teeth
    0
    0%
    0
    0%
    0
    0%
    Dental Restorations
    0
    0%
    0
    0%
    0
    0%
    4. Primary Outcome
    Title Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 3
    Description Buccal, labial and sublingual mucosae, mucobuccal fold, gingiva, tongue, hard and soft palate, uvula, oropharynx, teeth and dental restorations were examined. The dental examiner evaluated any condition as either normal or abnormal.
    Time Frame Day 3

    Outcome Measure Data

    Analysis Population Description
    Analysis was based on subjects with measurements for this variable.
    Arm/Group Title 19292-116-A Control (Listerine®) 12027-019 12027-020
    Arm/Group Description Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL) 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
    Measure Participants 27 26 26
    Buccal Mucosa
    0
    0%
    0
    0%
    3.8
    14.1%
    Labial Mucosa
    0
    0%
    0
    0%
    0
    0%
    Sublingual Mucosa
    0
    0%
    0
    0%
    0
    0%
    Mucobuccal Fold
    0
    0%
    0
    0%
    0
    0%
    Gingiva
    0
    0%
    0
    0%
    0
    0%
    Tongue
    25.9
    95.9%
    0
    0%
    3.8
    14.1%
    Hard/Soft Palate
    0
    0%
    0
    0%
    0
    0%
    Uvula/Oropharynx
    0
    0%
    0
    0%
    0
    0%
    Teeth
    0
    0%
    0
    0%
    0
    0%
    Dental Restorations
    0
    0%
    0
    0%
    0
    0%
    5. Primary Outcome
    Title Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 5
    Description Buccal, labial and sublingual mucosae, mucobuccal fold, gingiva, tongue, hard and soft palate, uvula, oropharynx, teeth and dental restorations were examined. The dental examiner evaluated any condition as either normal or abnormal.
    Time Frame Day 5

    Outcome Measure Data

    Analysis Population Description
    Analysis was based on subjects with measurements for this variable.
    Arm/Group Title 19292-116-A Control (Listerine®) 12027-019 12027-020
    Arm/Group Description Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL) 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
    Measure Participants 27 26 25
    Buccal Mucosa
    0
    0%
    0
    0%
    4.0
    14.8%
    Labial Mucosa
    0
    0%
    0
    0%
    0
    0%
    Sublingual Mucosa
    0
    0%
    0
    0%
    0
    0%
    Mucobuccal Fold
    0
    0%
    0
    0%
    0
    0%
    Gingiva
    0
    0%
    0
    0%
    0
    0%
    Tongue
    22.2
    82.2%
    0
    0%
    4.0
    14.8%
    Hard/Soft Palate
    0
    0%
    0
    0%
    0
    0%
    Uvula/Oropharynx
    0
    0%
    0
    0%
    0
    0%
    Teeth
    0
    0%
    0
    0%
    0
    0%
    Dental Restorations
    0
    0%
    0
    0%
    0
    0%
    6. Primary Outcome
    Title Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 24 - Pretreatment
    Description Buccal, labial and sublingual mucosae, mucobuccal fold, gingiva, tongue, hard and soft palate, uvula, oropharynx, teeth and dental restorations were examined. The dental examiner evaluated any condition as either normal or abnormal.
    Time Frame Day 24 - Pretreatment

    Outcome Measure Data

    Analysis Population Description
    Analysis was based on subjects with measurements for this variable.
    Arm/Group Title 19292-116-A Control (Listerine®) 12027-019 12027-020
    Arm/Group Description Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL) 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
    Measure Participants 27 26 23
    Buccal Mucosa
    3.7
    13.7%
    0
    0%
    0
    0%
    Labial Mucosa
    0
    0%
    0
    0%
    0
    0%
    Sublingual Mucosa
    0
    0%
    0
    0%
    0
    0%
    Mucobuccal Fold
    0
    0%
    0
    0%
    0
    0%
    Gingiva
    0
    0%
    0
    0%
    0
    0%
    Tongue
    3.7
    13.7%
    0
    0%
    4.3
    15.9%
    Hard/Soft Palate
    0
    0%
    0
    0%
    0
    0%
    Uvula/Oropharynx
    0
    0%
    0
    0%
    0
    0%
    Teeth
    0
    0%
    0
    0%
    0
    0%
    Dental Restorations
    0
    0%
    0
    0%
    0
    0%
    7. Primary Outcome
    Title Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 24 - Post-treatment
    Description Buccal, labial and sublingual mucosae, mucobuccal fold, gingiva, tongue, hard and soft palate, uvula, oropharynx, teeth and dental restorations were examined. The dental examiner evaluated any condition as either normal or abnormal.
    Time Frame Day 24 - Post-treatment

    Outcome Measure Data

    Analysis Population Description
    Analysis was based on subjects with measurements for this variable.
    Arm/Group Title 19292-116-A Control (Listerine®) 12027-019 12027-020
    Arm/Group Description Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL) 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
    Measure Participants 26 26 23
    Buccal Mucosa
    0
    0%
    0
    0%
    0
    0%
    Labial Mucosa
    0
    0%
    0
    0%
    0
    0%
    Sublingual Mucosa
    0
    0%
    0
    0%
    0
    0%
    Mucobuccal Fold
    0
    0%
    0
    0%
    0
    0%
    Gingiva
    0
    0%
    0
    0%
    0
    0%
    Tongue
    15.4
    57%
    0
    0%
    4.3
    15.9%
    Hard/Soft Palate
    0
    0%
    0
    0%
    0
    0%
    Uvula/Oropharynx
    0
    0%
    0
    0%
    0
    0%
    Teeth
    0
    0%
    0
    0%
    0
    0%
    Dental Restorations
    0
    0%
    0
    0%
    0
    0%
    8. Primary Outcome
    Title Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 25
    Description Buccal, labial and sublingual mucosae, mucobuccal fold, gingiva, tongue, hard and soft palate, uvula, oropharynx, teeth and dental restorations were examined. The dental examiner evaluated any condition as either normal or abnormal.
    Time Frame Day 25

    Outcome Measure Data

    Analysis Population Description
    Analysis was based on subjects with measurements for this variable.
    Arm/Group Title 19292-116-A Control (Listerine®) 12027-019 12027-020
    Arm/Group Description Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL) 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
    Measure Participants 26 26 23
    Buccal Mucosa
    0
    0%
    0
    0%
    0
    0%
    Labial Mucosa
    0
    0%
    0
    0%
    0
    0%
    Sublingual Mucosa
    0
    0%
    0
    0%
    0
    0%
    Mucobuccal Fold
    0
    0%
    0
    0%
    0
    0%
    Gingiva
    0
    0%
    0
    0%
    0
    0%
    Tongue
    0
    0%
    0
    0%
    4.3
    15.9%
    Hard/Soft Palate
    0
    0%
    0
    0%
    0
    0%
    Uvula/Oropharynx
    0
    0%
    0
    0%
    0
    0%
    Teeth
    0
    0%
    0
    0%
    0
    0%
    Dental Restorations
    0
    0%
    0
    0%
    0
    0%
    9. Primary Outcome
    Title Percentage of Subjects in Irritation Score Category for Buccal Mucosa at Screening
    Description The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).
    Time Frame Screening

    Outcome Measure Data

    Analysis Population Description
    Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.
    Arm/Group Title 19292-116-A Control (Listerine®) 12027-019 12027-020
    Arm/Group Description Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL) 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
    Measure Participants 27 26 27
    None
    100
    370.4%
    100
    384.6%
    100
    370.4%
    Mild
    0
    0%
    0
    0%
    0
    0%
    Moderate
    0
    0%
    0
    0%
    0
    0%
    Severe
    0
    0%
    0
    0%
    0
    0%
    10. Primary Outcome
    Title Percentage of Subjects in Irritation Score Category for Labial Mucosa at Screening
    Description The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).
    Time Frame Screening

    Outcome Measure Data

    Analysis Population Description
    Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.
    Arm/Group Title 19292-116-A Control (Listerine®) 12027-019 12027-020
    Arm/Group Description Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL) 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
    Measure Participants 27 26 27
    None
    100
    370.4%
    100
    384.6%
    100
    370.4%
    Mild
    0
    0%
    0
    0%
    0
    0%
    Moderate
    0
    0%
    0
    0%
    0
    0%
    Severe
    0
    0%
    0
    0%
    0
    0%
    11. Primary Outcome
    Title Percentage of Subjects in Irritation Score Category for Sublingual Mucosa at Screening
    Description The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).
    Time Frame Screening

    Outcome Measure Data

    Analysis Population Description
    Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.
    Arm/Group Title 19292-116-A Control (Listerine®) 12027-019 12027-020
    Arm/Group Description Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL) 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
    Measure Participants 27 26 27
    None
    100
    370.4%
    100
    384.6%
    100
    370.4%
    Mild
    0
    0%
    0
    0%
    0
    0%
    Moderate
    0
    0%
    0
    0%
    0
    0%
    Severe
    0
    0%
    0
    0%
    0
    0%
    12. Primary Outcome
    Title Percentage of Subjects in Irritation Score Category for Mucobuccal Fold at Screening
    Description The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).
    Time Frame Screening

    Outcome Measure Data

    Analysis Population Description
    Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.
    Arm/Group Title 19292-116-A Control (Listerine®) 12027-019 12027-020
    Arm/Group Description Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL) 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
    Measure Participants 27 26 27
    None
    100
    370.4%
    96.2
    370%
    100
    370.4%
    Mild
    0
    0%
    3.8
    14.6%
    0
    0%
    Moderate
    0
    0%
    0
    0%
    0
    0%
    Severe
    0
    0%
    0
    0%
    0
    0%
    13. Primary Outcome
    Title Percentage of Subjects in Irritation Score Category for Gingiva at Screening
    Description The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).
    Time Frame Screening

    Outcome Measure Data

    Analysis Population Description
    Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.
    Arm/Group Title 19292-116-A Control (Listerine®) 12027-019 12027-020
    Arm/Group Description Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL) 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
    Measure Participants 27 26 27
    None
    100
    370.4%
    100
    384.6%
    100
    370.4%
    Mild
    0
    0%
    0
    0%
    0
    0%
    Moderate
    0
    0%
    0
    0%
    0
    0%
    Severe
    0
    0%
    0
    0%
    0
    0%
    14. Primary Outcome
    Title Percentage of Subjects in Irritation Score Category for Tongue at Screening
    Description The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).
    Time Frame Screening

    Outcome Measure Data

    Analysis Population Description
    Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.
    Arm/Group Title 19292-116-A Control (Listerine®) 12027-019 12027-020
    Arm/Group Description Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL) 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
    Measure Participants 27 26 27
    None
    100
    370.4%
    96.2
    370%
    100
    370.4%
    Mild
    0
    0%
    3.8
    14.6%
    0
    0%
    Moderate
    0
    0%
    0
    0%
    0
    0%
    Severe
    0
    0%
    0
    0%
    0
    0%
    15. Primary Outcome
    Title Percentage of Subjects in Irritation Score Category for Hard/Soft Palate at Screening
    Description The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).
    Time Frame Screening

    Outcome Measure Data

    Analysis Population Description
    Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.
    Arm/Group Title 19292-116-A Control (Listerine®) 12027-019 12027-020
    Arm/Group Description Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL) 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
    Measure Participants 27 26 27
    None
    100
    370.4%
    100
    384.6%
    100
    370.4%
    Mild
    0
    0%
    0
    0%
    0
    0%
    Moderate
    0
    0%
    0
    0%
    0
    0%
    Severe
    0
    0%
    0
    0%
    0
    0%
    16. Primary Outcome
    Title Percentage of Subjects in Irritation Score Category for Uvula/Oropharynx at Screening
    Description The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).
    Time Frame Screening

    Outcome Measure Data

    Analysis Population Description
    Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.
    Arm/Group Title 19292-116-A Control (Listerine®) 12027-019 12027-020
    Arm/Group Description Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL) 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
    Measure Participants 27 26 27
    None
    100
    370.4%
    100
    384.6%
    100
    370.4%
    Mild
    0
    0%
    0
    0%
    0
    0%
    Moderate
    0
    0%
    0
    0%
    0
    0%
    Severe
    0
    0%
    0
    0%
    0
    0%
    17. Primary Outcome
    Title Percentage of Subjects in Irritation Score Category for Buccal Mucosa at Day 1 - Baseline/Pretreatment
    Description The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).
    Time Frame Day 1 - Baseline/Pretreatment

    Outcome Measure Data

    Analysis Population Description
    Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.
    Arm/Group Title 19292-116-A Control (Listerine®) 12027-019 12027-020
    Arm/Group Description Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL) 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
    Measure Participants 27 26 27
    None
    100
    370.4%
    100
    384.6%
    100
    370.4%
    Mild
    0
    0%
    0
    0%
    0
    0%
    Moderate
    0
    0%
    0
    0%
    0
    0%
    Severe
    0
    0%
    0
    0%
    0
    0%
    18. Primary Outcome
    Title Percentage of Subjects in Irritation Score Category for Labial Mucosa at Day 1 - Baseline/Pretreatment
    Description The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).
    Time Frame Day 1 - Baseline/Pretreatment

    Outcome Measure Data

    Analysis Population Description
    Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.
    Arm/Group Title 19292-116-A Control (Listerine®) 12027-019 12027-020
    Arm/Group Description Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL) 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
    Measure Participants 27 26 27
    None
    100
    370.4%
    100
    384.6%
    100
    370.4%
    Mild
    0
    0%
    0
    0%
    0
    0%
    Moderate
    0
    0%
    0
    0%
    0
    0%
    Severe
    0
    0%
    0
    0%
    0
    0%
    19. Primary Outcome
    Title Percentage of Subjects in Irritation Score Category for Sublingual Mucosa at Day 1 - Baseline/Pretreatment
    Description The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).
    Time Frame Day 1 - Baseline/Pretreatment

    Outcome Measure Data

    Analysis Population Description
    Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.
    Arm/Group Title 19292-116-A Control (Listerine®) 12027-019 12027-020
    Arm/Group Description Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL) 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
    Measure Participants 27 26 27
    None
    100
    370.4%
    100
    384.6%
    100
    370.4%
    Mild
    0
    0%
    0
    0%
    0
    0%
    Moderate
    0
    0%
    0
    0%
    0
    0%
    Severe
    0
    0%
    0
    0%
    0
    0%
    20. Primary Outcome
    Title Percentage of Subjects in Irritation Score Category for Mucobuccal Fold at Day 1 - Baseline/Pretreatment
    Description The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).
    Time Frame Day 1 - Baseline/Pretreatment

    Outcome Measure Data

    Analysis Population Description
    Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.
    Arm/Group Title 19292-116-A Control (Listerine®) 12027-019 12027-020
    Arm/Group Description Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL) 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
    Measure Participants 27 26 27
    None
    100
    370.4%
    100
    384.6%
    100
    370.4%
    Mild
    0
    0%
    0
    0%
    0
    0%
    Moderate
    0
    0%
    0
    0%
    0
    0%
    Severe
    0
    0%
    0
    0%
    0
    0%
    21. Primary Outcome
    Title Percentage of Subjects in Irritation Score Category for Gingiva at Day 1 - Baseline/Pretreatment
    Description The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).
    Time Frame Day 1 - Baseline/Pretreatment

    Outcome Measure Data

    Analysis Population Description
    Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.
    Arm/Group Title 19292-116-A Control (Listerine®) 12027-019 12027-020
    Arm/Group Description Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL) 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
    Measure Participants 27 26 27
    None
    100
    370.4%
    100
    384.6%
    100
    370.4%
    Mild
    0
    0%
    0
    0%
    0
    0%
    Moderate
    0
    0%
    0
    0%
    0
    0%
    Severe
    0
    0%
    0
    0%
    0
    0%
    22. Primary Outcome
    Title Percentage of Subjects in Irritation Score Category for Tongue at Day 1 - Baseline/Pretreatment
    Description The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).
    Time Frame Day 1 - Baseline/Pretreatment

    Outcome Measure Data

    Analysis Population Description
    Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.
    Arm/Group Title 19292-116-A Control (Listerine®) 12027-019 12027-020
    Arm/Group Description Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL) 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
    Measure Participants 27 26 27
    None
    96.3
    356.7%
    100
    384.6%
    100
    370.4%
    Mild
    3.7
    13.7%
    0
    0%
    0
    0%
    Moderate
    0
    0%
    0
    0%
    0
    0%
    Severe
    0
    0%
    0
    0%
    0
    0%
    23. Primary Outcome
    Title Percentage of Subjects in Irritation Score Category for Hard/Soft Palate at Day 1 - Baseline/Pretreatment
    Description The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).
    Time Frame Day 1 - Baseline/Pretreatment

    Outcome Measure Data

    Analysis Population Description
    Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.
    Arm/Group Title 19292-116-A Control (Listerine®) 12027-019 12027-020
    Arm/Group Description Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL) 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
    Measure Participants 27 26 27
    None
    100
    370.4%
    100
    384.6%
    100
    370.4%
    Mild
    0
    0%
    0
    0%
    0
    0%
    Moderate
    0
    0%
    0
    0%
    0
    0%
    Severe
    0
    0%
    0
    0%
    0
    0%
    24. Primary Outcome
    Title Percentage of Subjects in Irritation Score Category for Uvula/Oropharynx at Day 1 - Baseline/Pretreatment
    Description The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).
    Time Frame Day 1 - Baseline/Pretreatment

    Outcome Measure Data

    Analysis Population Description
    Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.
    Arm/Group Title 19292-116-A Control (Listerine®) 12027-019 12027-020
    Arm/Group Description Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL) 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
    Measure Participants 27 26 27
    None
    100
    370.4%
    100
    384.6%
    100
    370.4%
    Mild
    0
    0%
    0
    0%
    0
    0%
    Moderate
    0
    0%
    0
    0%
    0
    0%
    Severe
    0
    0%
    0
    0%
    0
    0%
    25. Primary Outcome
    Title Percentage of Subjects in Irritation Score Category for Buccal Mucosa at Day 1 - Post-treatment
    Description The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).
    Time Frame Day 1 - Post-treatment

    Outcome Measure Data

    Analysis Population Description
    Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.
    Arm/Group Title 19292-116-A Control (Listerine®) 12027-019 12027-020
    Arm/Group Description Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL) 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
    Measure Participants 27 26 26
    None
    100
    370.4%
    100
    384.6%
    96.2
    356.3%
    Mild
    0
    0%
    0
    0%
    3.8
    14.1%
    Moderate
    0
    0%
    0
    0%
    0
    0%
    Severe
    0
    0%
    0
    0%
    0
    0%
    26. Primary Outcome
    Title Percentage of Subjects in Irritation Score Category for Labial Mucosa at Day 1 - Post-treatment
    Description The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).
    Time Frame Day 1 - Post-treatment

    Outcome Measure Data

    Analysis Population Description
    Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.
    Arm/Group Title 19292-116-A Control (Listerine®) 12027-019 12027-020
    Arm/Group Description Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL) 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
    Measure Participants 27 26 26
    None
    100
    370.4%
    100
    384.6%
    100
    370.4%
    Mild
    0
    0%
    0
    0%
    0
    0%
    Moderate
    0
    0%
    0
    0%
    0
    0%
    Severe
    0
    0%
    0
    0%
    0
    0%
    27. Primary Outcome
    Title Percentage of Subjects in Irritation Score Category for Sublingual Mucosa at Day 1 - Post-treatment
    Description The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).
    Time Frame Day 1 - Post-treatment

    Outcome Measure Data

    Analysis Population Description
    Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.
    Arm/Group Title 19292-116-A Control (Listerine®) 12027-019 12027-020
    Arm/Group Description Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL) 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
    Measure Participants 27 26 26
    None
    100
    370.4%
    100
    384.6%
    100
    370.4%
    Mild
    0
    0%
    0
    0%
    0
    0%
    Moderate
    0
    0%
    0
    0%
    0
    0%
    Severe
    0
    0%
    0
    0%
    0
    0%
    28. Primary Outcome
    Title Percentage of Subjects in Irritation Score Category for Mucobuccal Fold at Day 1 - Post-treatment
    Description The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).
    Time Frame Day 1 - Post-treatment

    Outcome Measure Data

    Analysis Population Description
    Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.
    Arm/Group Title 19292-116-A Control (Listerine®) 12027-019 12027-020
    Arm/Group Description Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL) 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
    Measure Participants 27 26 26
    None
    100
    370.4%
    100
    384.6%
    100
    370.4%
    Mild
    0
    0%
    0
    0%
    0
    0%
    Moderate
    0
    0%
    0
    0%
    0
    0%
    Severe
    0
    0%
    0
    0%
    0
    0%
    29. Primary Outcome
    Title Percentage of Subjects in Irritation Score Category for Gingiva at Day 1 - Post-treatment
    Description The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).
    Time Frame Day 1 - Post-treatment

    Outcome Measure Data

    Analysis Population Description
    Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.
    Arm/Group Title 19292-116-A Control (Listerine®) 12027-019 12027-020
    Arm/Group Description Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL) 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
    Measure Participants 27 26 26
    None
    100
    370.4%
    100
    384.6%
    100
    370.4%
    Mild
    0
    0%
    0
    0%
    0
    0%
    Moderate
    0
    0%
    0
    0%
    0
    0%
    Severe
    0
    0%
    0
    0%
    0
    0%
    30. Primary Outcome
    Title Percentage of Subjects in Irritation Score Category for Tongue at Day 1 - Post-treatment
    Description The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).
    Time Frame Day 1 - Post-treatment

    Outcome Measure Data

    Analysis Population Description
    Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.
    Arm/Group Title 19292-116-A Control (Listerine®) 12027-019 12027-020
    Arm/Group Description Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL) 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
    Measure Participants 27 26 26
    None
    96.3
    356.7%
    100
    384.6%
    96.2
    356.3%
    Mild
    3.7
    13.7%
    0
    0%
    3.8
    14.1%
    Moderate
    0
    0%
    0
    0%
    0
    0%
    Severe
    0
    0%
    0
    0%
    0
    0%
    31. Primary Outcome
    Title Percentage of Subjects in Irritation Score Category for Hard/Soft Palate at Day 1 - Post-treatment
    Description The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).
    Time Frame Day 1 - Post-treatment

    Outcome Measure Data

    Analysis Population Description
    Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.
    Arm/Group Title 19292-116-A Control (Listerine®) 12027-019 12027-020
    Arm/Group Description Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL) 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
    Measure Participants 27 26 26
    None
    100
    370.4%
    100
    384.6%
    100
    370.4%
    Mild
    0
    0%
    0
    0%
    0
    0%
    Moderate
    0
    0%
    0
    0%
    0
    0%
    Severe
    0
    0%
    0
    0%
    0
    0%
    32. Primary Outcome
    Title Percentage of Subjects in Irritation Score Category for Uvula/Oropharynx at Day 1 - Post-treatment
    Description The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).
    Time Frame Day 1 - Post-treatment

    Outcome Measure Data

    Analysis Population Description
    Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.
    Arm/Group Title 19292-116-A Control (Listerine®) 12027-019 12027-020
    Arm/Group Description Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL) 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
    Measure Participants 27 26 26
    None
    100
    370.4%
    100
    384.6%
    100
    370.4%
    Mild
    0
    0%
    0
    0%
    0
    0%
    Moderate
    0
    0%
    0
    0%
    0
    0%
    Severe
    0
    0%
    0
    0%
    0
    0%
    33. Primary Outcome
    Title Percentage of Subjects in Irritation Score Category for Buccal Mucosa at Day 3
    Description The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).
    Time Frame Day 3

    Outcome Measure Data

    Analysis Population Description
    Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.
    Arm/Group Title 19292-116-A Control (Listerine®) 12027-019 12027-020
    Arm/Group Description Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL) 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
    Measure Participants 27 26 26
    None
    100
    370.4%
    100
    384.6%
    96.2
    356.3%
    Mild
    0
    0%
    0
    0%
    3.8
    14.1%
    Moderate
    0
    0%
    0
    0%
    0
    0%
    Severe
    0
    0%
    0
    0%
    0
    0%
    34. Primary Outcome
    Title Percentage of Subjects in Irritation Score Category for Labial Mucosa at Day 3
    Description The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).
    Time Frame Day 3

    Outcome Measure Data

    Analysis Population Description
    Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.
    Arm/Group Title 19292-116-A Control (Listerine®) 12027-019 12027-020
    Arm/Group Description Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL) 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
    Measure Participants 27 26 26
    None
    100
    370.4%
    100
    384.6%
    100
    370.4%
    Mild
    0
    0%
    0
    0%
    0
    0%
    Moderate
    0
    0%
    0
    0%
    0
    0%
    Severe
    0
    0%
    0
    0%
    0
    0%
    35. Primary Outcome
    Title Percentage of Subjects in Irritation Score Category for Sublingual Mucosa at Day 3
    Description The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).
    Time Frame Day 3

    Outcome Measure Data

    Analysis Population Description
    Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.
    Arm/Group Title 19292-116-A Control (Listerine®) 12027-019 12027-020
    Arm/Group Description Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL) 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
    Measure Participants 27 26 26
    None
    100
    370.4%
    100
    384.6%
    100
    370.4%
    Mild
    0
    0%
    0
    0%
    0
    0%
    Moderate
    0
    0%
    0
    0%
    0
    0%
    Severe
    0
    0%
    0
    0%
    0
    0%
    36. Primary Outcome
    Title Percentage of Subjects in Irritation Score Category for Mucobuccal Fold at Day 3
    Description The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).
    Time Frame Day 3

    Outcome Measure Data

    Analysis Population Description
    Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.
    Arm/Group Title 19292-116-A Control (Listerine®) 12027-019 12027-020
    Arm/Group Description Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL) 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
    Measure Participants 27 26 26
    None
    100
    370.4%
    100
    384.6%
    100
    370.4%
    Mild
    0
    0%
    0
    0%
    0
    0%
    Moderate
    0
    0%
    0
    0%
    0
    0%
    Severe
    0
    0%
    0
    0%
    0
    0%
    37. Primary Outcome
    Title Percentage of Subjects in Irritation Score Category for Gingiva at Day 3
    Description The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).
    Time Frame Day 3

    Outcome Measure Data

    Analysis Population Description
    Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.
    Arm/Group Title 19292-116-A Control (Listerine®) 12027-019 12027-020
    Arm/Group Description Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL) 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
    Measure Participants 27 26 26
    None
    100
    370.4%
    100
    384.6%
    100
    370.4%
    Mild
    0
    0%
    0
    0%
    0
    0%
    Moderate
    0
    0%
    0
    0%
    0
    0%
    Severe
    0
    0%
    0
    0%
    0
    0%
    38. Primary Outcome
    Title Percentage of Subjects in Irritation Score Category for Tongue at Day 3
    Description The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).
    Time Frame Day 3

    Outcome Measure Data

    Analysis Population Description
    Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.
    Arm/Group Title 19292-116-A Control (Listerine®) 12027-019 12027-020
    Arm/Group Description Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL) 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
    Measure Participants 27 26 26
    None
    100
    370.4%
    100
    384.6%
    100
    370.4%
    Mild
    0
    0%
    0
    0%
    0
    0%
    Moderate
    0
    0%
    0
    0%
    0
    0%
    Severe
    0
    0%
    0
    0%
    0
    0%
    39. Primary Outcome
    Title Percentage of Subjects in Irritation Score Category for Hard/Soft Palate at Day 3
    Description The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).
    Time Frame Day 3

    Outcome Measure Data

    Analysis Population Description
    Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.
    Arm/Group Title 19292-116-A Control (Listerine®) 12027-019 12027-020
    Arm/Group Description Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL) 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
    Measure Participants 27 26 26
    None
    100
    370.4%
    100
    384.6%
    100
    370.4%
    Mild
    0
    0%
    0
    0%
    0
    0%
    Moderate
    0
    0%
    0
    0%
    0
    0%
    Severe
    0
    0%
    0
    0%
    0
    0%
    40. Primary Outcome
    Title Percentage of Subjects in Irritation Score Category for Uvula/Oropharynx at Day 3
    Description The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).
    Time Frame Day 3

    Outcome Measure Data

    Analysis Population Description
    Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.
    Arm/Group Title 19292-116-A Control (Listerine®) 12027-019 12027-020
    Arm/Group Description Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL) 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
    Measure Participants 27 26 26
    None
    100
    370.4%
    100
    384.6%
    100
    370.4%
    Mild
    0
    0%
    0
    0%
    0
    0%
    Moderate
    0
    0%
    0
    0%
    0
    0%
    Severe
    0
    0%
    0
    0%
    0
    0%
    41. Primary Outcome
    Title Percentage of Subjects in Irritation Score Category for Buccal Mucosa at Day 5
    Description The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).
    Time Frame Day 5

    Outcome Measure Data

    Analysis Population Description
    Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.
    Arm/Group Title 19292-116-A Control (Listerine®) 12027-019 12027-020
    Arm/Group Description Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL) 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
    Measure Participants 27 26 25
    None
    100
    370.4%
    100
    384.6%
    96.0
    355.6%
    Mild
    0
    0%
    0
    0%
    4.0
    14.8%
    Moderate
    0
    0%
    0
    0%
    0
    0%
    Severe
    0
    0%
    0
    0%
    0
    0%
    42. Primary Outcome
    Title Percentage of Subjects in Irritation Score Category for Labial Mucosa at Day 5
    Description The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).
    Time Frame Day 5

    Outcome Measure Data

    Analysis Population Description
    Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.
    Arm/Group Title 19292-116-A Control (Listerine®) 12027-019 12027-020
    Arm/Group Description Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL) 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
    Measure Participants 27 26 25
    None
    100
    370.4%
    100
    384.6%
    100
    370.4%
    Mild
    0
    0%
    0
    0%
    0
    0%
    Moderate
    0
    0%
    0
    0%
    0
    0%
    Severe
    0
    0%
    0
    0%
    0
    0%
    43. Primary Outcome
    Title Percentage of Subjects in Irritation Score Category for Sublingual Mucosa at Day 5
    Description The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).
    Time Frame Day 5

    Outcome Measure Data

    Analysis Population Description
    Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.
    Arm/Group Title 19292-116-A Control (Listerine®) 12027-019 12027-020
    Arm/Group Description Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL) 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
    Measure Participants 27 26 25
    None
    100
    370.4%
    100
    384.6%
    100
    370.4%
    Mild
    0
    0%
    0
    0%
    0
    0%
    Moderate
    0
    0%
    0
    0%
    0
    0%
    Severe
    0
    0%
    0
    0%
    0
    0%
    44. Primary Outcome
    Title Percentage of Subjects in Irritation Score Category for Mucobuccal Fold at Day 5
    Description The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).
    Time Frame Day 5

    Outcome Measure Data

    Analysis Population Description
    Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.
    Arm/Group Title 19292-116-A Control (Listerine®) 12027-019 12027-020
    Arm/Group Description Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL) 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
    Measure Participants 27 26 25
    None
    100
    370.4%
    100
    384.6%
    100
    370.4%
    Mild
    0
    0%
    0
    0%
    0
    0%
    Moderate
    0
    0%
    0
    0%
    0
    0%
    Severe
    0
    0%
    0
    0%
    0
    0%
    45. Primary Outcome
    Title Percentage of Subjects in Irritation Score Category for Gingiva at Day 5
    Description The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).
    Time Frame Day 5

    Outcome Measure Data

    Analysis Population Description
    Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.
    Arm/Group Title 19292-116-A Control (Listerine®) 12027-019 12027-020
    Arm/Group Description Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL) 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
    Measure Participants 27 26 25
    None
    100
    370.4%
    100
    384.6%
    100
    370.4%
    Mild
    0
    0%
    0
    0%
    0
    0%
    Moderate
    0
    0%
    0
    0%
    0
    0%
    Severe
    0
    0%
    0
    0%
    0
    0%
    46. Primary Outcome
    Title Percentage of Subjects in Irritation Score Category for Tongue at Day 5
    Description The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).
    Time Frame Day 5

    Outcome Measure Data

    Analysis Population Description
    Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.
    Arm/Group Title 19292-116-A Control (Listerine®) 12027-019 12027-020
    Arm/Group Description Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL) 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
    Measure Participants 27 26 25
    None
    100
    370.4%
    100
    384.6%
    100
    370.4%
    Mild
    0
    0%
    0
    0%
    0
    0%
    Moderate
    0
    0%
    0
    0%
    0
    0%
    Severe
    0
    0%
    0
    0%
    0
    0%
    47. Primary Outcome
    Title Percentage of Subjects in Irritation Score Category for Hard/Soft Palate at Day 5
    Description The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).
    Time Frame Day 5

    Outcome Measure Data

    Analysis Population Description
    Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.
    Arm/Group Title 19292-116-A Control (Listerine®) 12027-019 12027-020
    Arm/Group Description Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL) 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
    Measure Participants 27 26 25
    None
    100
    370.4%
    100
    384.6%
    100
    370.4%
    Mild
    0
    0%
    0
    0%
    0
    0%
    Moderate
    0
    0%
    0
    0%
    0
    0%
    Severe
    0
    0%
    0
    0%
    0
    0%
    48. Primary Outcome
    Title Percentage of Subjects in Irritation Score Category for Uvula/Oropharynx at Day 5
    Description The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).
    Time Frame Day 5

    Outcome Measure Data

    Analysis Population Description
    Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.
    Arm/Group Title 19292-116-A Control (Listerine®) 12027-019 12027-020
    Arm/Group Description Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL) 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
    Measure Participants 27 26 25
    None
    100
    370.4%
    100
    384.6%
    100
    370.4%
    Mild
    0
    0%
    0
    0%
    0
    0%
    Moderate
    0
    0%
    0
    0%
    0
    0%
    Severe
    0
    0%
    0
    0%
    0
    0%
    49. Primary Outcome
    Title Percentage of Subjects in Irritation Score Category for Buccal Mucosa at Day 24 - Pretreatment
    Description The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).
    Time Frame Day 24 - Pretreatment

    Outcome Measure Data

    Analysis Population Description
    Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.
    Arm/Group Title 19292-116-A Control (Listerine®) 12027-019 12027-020
    Arm/Group Description Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL) 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
    Measure Participants 27 26 23
    None
    96.3
    356.7%
    100
    384.6%
    100
    370.4%
    Mild
    0
    0%
    0
    0%
    0
    0%
    Moderate
    3.7
    13.7%
    0
    0%
    0
    0%
    Severe
    0
    0%
    0
    0%
    0
    0%
    50. Primary Outcome
    Title Percentage of Subjects in Irritation Score Category for Labial Mucosa at Day 24 - Pretreatment
    Description The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).
    Time Frame Day 24 - Pretreatment

    Outcome Measure Data

    Analysis Population Description
    Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.
    Arm/Group Title 19292-116-A Control (Listerine®) 12027-019 12027-020
    Arm/Group Description Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL) 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
    Measure Participants 27 26 23
    None
    100
    370.4%
    100
    384.6%
    100
    370.4%
    Mild
    0
    0%
    0
    0%
    0
    0%
    Moderate
    0
    0%
    0
    0%
    0
    0%
    Severe
    0
    0%
    0
    0%
    0
    0%
    51. Primary Outcome
    Title Percentage of Subjects in Irritation Score Category for Sublingual Mucosa at Day 24 - Pretreatment
    Description The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).
    Time Frame Day 24 - Pretreatment

    Outcome Measure Data

    Analysis Population Description
    Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.
    Arm/Group Title 19292-116-A Control (Listerine®) 12027-019 12027-020
    Arm/Group Description Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL) 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
    Measure Participants 27 26 23
    None
    100
    370.4%
    100
    384.6%
    100
    370.4%
    Mild
    0
    0%
    0
    0%
    0
    0%
    Moderate
    0
    0%
    0
    0%
    0
    0%
    Severe
    0
    0%
    0
    0%
    0
    0%
    52. Primary Outcome
    Title Percentage of Subjects in Irritation Score Category for Mucobuccal Fold at Day 24 - Pretreatment
    Description The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).
    Time Frame Day 24 - Pretreatment

    Outcome Measure Data

    Analysis Population Description
    Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.
    Arm/Group Title 19292-116-A Control (Listerine®) 12027-019 12027-020
    Arm/Group Description Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL) 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
    Measure Participants 27 26 23
    None
    100
    370.4%
    100
    384.6%
    100
    370.4%
    Mild
    0
    0%
    0
    0%
    0
    0%
    Moderate
    0
    0%
    0
    0%
    0
    0%
    Severe
    0
    0%
    0
    0%
    0
    0%
    53. Primary Outcome
    Title Percentage of Subjects in Irritation Score Category for Gingiva at Day 24 - Pretreatment
    Description The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).
    Time Frame Day 24 - Pretreatment

    Outcome Measure Data

    Analysis Population Description
    Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.
    Arm/Group Title 19292-116-A Control (Listerine®) 12027-019 12027-020
    Arm/Group Description Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL) 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
    Measure Participants 27 26 23
    None
    100
    370.4%
    100
    384.6%
    100
    370.4%
    Mild
    0
    0%
    0
    0%
    0
    0%
    Moderate
    0
    0%
    0
    0%
    0
    0%
    Severe
    0
    0%
    0
    0%
    0
    0%
    54. Primary Outcome
    Title Percentage of Subjects in Irritation Score Category for Tongue at Day 24 - Pretreatment
    Description The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).
    Time Frame Day 24 - Pretreatment

    Outcome Measure Data

    Analysis Population Description
    Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.
    Arm/Group Title 19292-116-A Control (Listerine®) 12027-019 12027-020
    Arm/Group Description Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL) 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
    Measure Participants 27 26 23
    None
    100
    370.4%
    100
    384.6%
    100
    370.4%
    Mild
    0
    0%
    0
    0%
    0
    0%
    Moderate
    0
    0%
    0
    0%
    0
    0%
    Severe
    0
    0%
    0
    0%
    0
    0%
    55. Primary Outcome
    Title Percentage of Subjects in Irritation Score Category for Hard/Soft Palate at Day 24 - Pretreatment
    Description The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).
    Time Frame Day 24 - Pretreatment

    Outcome Measure Data

    Analysis Population Description
    Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.
    Arm/Group Title 19292-116-A Control (Listerine®) 12027-019 12027-020
    Arm/Group Description Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL) 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
    Measure Participants 27 26 23
    None
    100
    370.4%
    100
    384.6%
    100
    370.4%
    Mild
    0
    0%
    0
    0%
    0
    0%
    Moderate
    0
    0%
    0
    0%
    0
    0%
    Severe
    0
    0%
    0
    0%
    0
    0%
    56. Primary Outcome
    Title Percentage of Subjects in Irritation Score Category for Uvula/Oropharynx at Day 24 - Pretreatment
    Description The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).
    Time Frame Day 24 - Pretreatment

    Outcome Measure Data

    Analysis Population Description
    Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.
    Arm/Group Title 19292-116-A Control (Listerine®) 12027-019 12027-020
    Arm/Group Description Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL) 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
    Measure Participants 27 26 23
    None
    100
    370.4%
    100
    384.6%
    100
    370.4%
    Mild
    0
    0%
    0
    0%
    0
    0%
    Moderate
    0
    0%
    0
    0%
    0
    0%
    Severe
    0
    0%
    0
    0%
    0
    0%
    57. Primary Outcome
    Title Percentage of Subjects in Irritation Score Category for Buccal Mucosa at Day 24 - Post-treatment
    Description The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).
    Time Frame Day 24 - Post-treatment

    Outcome Measure Data

    Analysis Population Description
    Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.
    Arm/Group Title 19292-116-A Control (Listerine®) 12027-019 12027-020
    Arm/Group Description Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL) 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
    Measure Participants 26 26 23
    None
    100
    370.4%
    100
    384.6%
    100
    370.4%
    Mild
    0
    0%
    0
    0%
    0
    0%
    Moderate
    0
    0%
    0
    0%
    0
    0%
    Severe
    0
    0%
    0
    0%
    0
    0%
    58. Primary Outcome
    Title Percentage of Subjects in Irritation Score Category for Labial Mucosa at Day 24 - Post-treatment
    Description The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).
    Time Frame Day 24 - Post-treatment

    Outcome Measure Data

    Analysis Population Description
    Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.
    Arm/Group Title 19292-116-A Control (Listerine®) 12027-019 12027-020
    Arm/Group Description Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL) 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
    Measure Participants 26 26 23
    None
    100
    370.4%
    100
    384.6%
    100
    370.4%
    Mild
    0
    0%
    0
    0%
    0
    0%
    Moderate
    0
    0%
    0
    0%
    0
    0%
    Severe
    0
    0%
    0
    0%
    0
    0%
    59. Primary Outcome
    Title Percentage of Subjects in Irritation Score Category for Sublingual Mucosa at Day 24 - Post-treatment
    Description The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).
    Time Frame Day 24 - Post-treatment

    Outcome Measure Data

    Analysis Population Description
    Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.
    Arm/Group Title 19292-116-A Control (Listerine®) 12027-019 12027-020
    Arm/Group Description Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL) 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
    Measure Participants 26 26 23
    None
    100
    370.4%
    100
    384.6%
    100
    370.4%
    Mild
    0
    0%
    0
    0%
    0
    0%
    Moderate
    0
    0%
    0
    0%
    0
    0%
    Severe
    0
    0%
    0
    0%
    0
    0%
    60. Primary Outcome
    Title Percentage of Subjects in Irritation Score Category for Mucobuccal Fold at Day 24 - Post-treatment
    Description The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).
    Time Frame Day 24 - Post-treatment

    Outcome Measure Data

    Analysis Population Description
    Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.
    Arm/Group Title 19292-116-A Control (Listerine®) 12027-019 12027-020
    Arm/Group Description Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL) 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
    Measure Participants 26 26 23
    None
    100
    370.4%
    100
    384.6%
    100
    370.4%
    Mild
    0
    0%
    0
    0%
    0
    0%
    Moderate
    0
    0%
    0
    0%
    0
    0%
    Severe
    0
    0%
    0
    0%
    0
    0%
    61. Primary Outcome
    Title Percentage of Subjects in Irritation Score Category for Gingiva at Day 24 - Post-treatment
    Description The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).
    Time Frame Day 24 - Post-treatment

    Outcome Measure Data

    Analysis Population Description
    Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.
    Arm/Group Title 19292-116-A Control (Listerine®) 12027-019 12027-020
    Arm/Group Description Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL) 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
    Measure Participants 26 26 23
    None
    100
    370.4%
    100
    384.6%
    100
    370.4%
    Mild
    0
    0%
    0
    0%
    0
    0%
    Moderate
    0
    0%
    0
    0%
    0
    0%
    Severe
    0
    0%
    0
    0%
    0
    0%
    62. Primary Outcome
    Title Percentage of Subjects in Irritation Score Category for Tongue at Day 24 - Post-treatment
    Description The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).
    Time Frame Day 24 - Post-treatment

    Outcome Measure Data

    Analysis Population Description
    Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.
    Arm/Group Title 19292-116-A Control (Listerine®) 12027-019 12027-020
    Arm/Group Description Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL) 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
    Measure Participants 26 26 23
    None
    100
    370.4%
    100
    384.6%
    100
    370.4%
    Mild
    0
    0%
    0
    0%
    0
    0%
    Moderate
    0
    0%
    0
    0%
    0
    0%
    Severe
    0
    0%
    0
    0%
    0
    0%
    63. Primary Outcome
    Title Percentage of Subjects in Irritation Score Category for Hard/Soft Palate at Day 24 - Post-treatment
    Description The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).
    Time Frame Day 24 - Post-treatment

    Outcome Measure Data

    Analysis Population Description
    Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.
    Arm/Group Title 19292-116-A Control (Listerine®) 12027-019 12027-020
    Arm/Group Description Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL) 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
    Measure Participants 26 26 23
    None
    100
    370.4%
    100
    384.6%
    100
    370.4%
    Mild
    0
    0%
    0
    0%
    0
    0%
    Moderate
    0
    0%
    0
    0%
    0
    0%
    Severe
    0
    0%
    0
    0%
    0
    0%
    64. Primary Outcome
    Title Percentage of Subjects in Irritation Score Category for Uvula/Oropharynx at Day 24 - Post-treatment
    Description The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).
    Time Frame Day 24 - Post-treatment

    Outcome Measure Data

    Analysis Population Description
    Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.
    Arm/Group Title 19292-116-A Control (Listerine®) 12027-019 12027-020
    Arm/Group Description Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL) 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
    Measure Participants 26 26 23
    None
    100
    370.4%
    100
    384.6%
    100
    370.4%
    Mild
    0
    0%
    0
    0%
    0
    0%
    Moderate
    0
    0%
    0
    0%
    0
    0%
    Severe
    0
    0%
    0
    0%
    0
    0%
    65. Primary Outcome
    Title Percentage of Subjects in Irritation Score Category for Buccal Mucosa at Day 25
    Description The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).
    Time Frame Day 25

    Outcome Measure Data

    Analysis Population Description
    Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.
    Arm/Group Title 19292-116-A Control (Listerine®) 12027-019 12027-020
    Arm/Group Description Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL) 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
    Measure Participants 26 26 23
    None
    100
    370.4%
    100
    384.6%
    100
    370.4%
    Mild
    0
    0%
    0
    0%
    0
    0%
    Moderate
    0
    0%
    0
    0%
    0
    0%
    Severe
    0
    0%
    0
    0%
    0
    0%
    66. Primary Outcome
    Title Percentage of Subjects in Irritation Score Category for Labial Mucosa at Day 25
    Description The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).
    Time Frame Day 25

    Outcome Measure Data

    Analysis Population Description
    Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.
    Arm/Group Title 19292-116-A Control (Listerine®) 12027-019 12027-020
    Arm/Group Description Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL) 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
    Measure Participants 26 26 23
    None
    100
    370.4%
    100
    384.6%
    100
    370.4%
    Mild
    0
    0%
    0
    0%
    0
    0%
    Moderate
    0
    0%
    0
    0%
    0
    0%
    Severe
    0
    0%
    0
    0%
    0
    0%
    67. Primary Outcome
    Title Percentage of Subjects in Irritation Score Category for Sublingual Mucosa at Day 25
    Description The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).
    Time Frame Day 25

    Outcome Measure Data

    Analysis Population Description
    Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.
    Arm/Group Title 19292-116-A Control (Listerine®) 12027-019 12027-020
    Arm/Group Description Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL) 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
    Measure Participants 26 26 23
    None
    100
    370.4%
    100
    384.6%
    100
    370.4%
    Mild
    0
    0%
    0
    0%
    0
    0%
    Moderate
    0
    0%
    0
    0%
    0
    0%
    Severe
    0
    0%
    0
    0%
    0
    0%
    68. Primary Outcome
    Title Percentage of Subjects in Irritation Score Category for Mucobuccal Fold at Day 25
    Description The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).
    Time Frame Day 25

    Outcome Measure Data

    Analysis Population Description
    Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.
    Arm/Group Title 19292-116-A Control (Listerine®) 12027-019 12027-020
    Arm/Group Description Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL) 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
    Measure Participants 26 26 23
    None
    100
    370.4%
    100
    384.6%
    100
    370.4%
    Mild
    0
    0%
    0
    0%
    0
    0%
    Moderate
    0
    0%
    0
    0%
    0
    0%
    Severe
    0
    0%
    0
    0%
    0
    0%
    69. Primary Outcome
    Title Percentage of Subjects in Irritation Score Category for Gingiva at Day 25
    Description The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).
    Time Frame Day 25

    Outcome Measure Data

    Analysis Population Description
    Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.
    Arm/Group Title 19292-116-A Control (Listerine®) 12027-019 12027-020
    Arm/Group Description Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL) 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
    Measure Participants 26 26 23
    None
    100
    370.4%
    100
    384.6%
    100
    370.4%
    Mild
    0
    0%
    0
    0%
    0
    0%
    Moderate
    0
    0%
    0
    0%
    0
    0%
    Severe
    0
    0%
    0
    0%
    0
    0%
    70. Primary Outcome
    Title Percentage of Subjects in Irritation Score Category for Tongue at Day 25
    Description The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).
    Time Frame Day 25

    Outcome Measure Data

    Analysis Population Description
    Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.
    Arm/Group Title 19292-116-A Control (Listerine®) 12027-019 12027-020
    Arm/Group Description Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL) 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
    Measure Participants 26 26 23
    None
    100
    370.4%
    100
    384.6%
    100
    370.4%
    Mild
    0
    0%
    0
    0%
    0
    0%
    Moderate
    0
    0%
    0
    0%
    0
    0%
    Severe
    0
    0%
    0
    0%
    0
    0%
    71. Primary Outcome
    Title Percentage of Subjects in Irritation Score Category for Hard/Soft Palate at Day 25
    Description The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).
    Time Frame Day 25

    Outcome Measure Data

    Analysis Population Description
    Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.
    Arm/Group Title 19292-116-A Control (Listerine®) 12027-019 12027-020
    Arm/Group Description Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL) 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
    Measure Participants 26 26 23
    None
    100
    370.4%
    100
    384.6%
    100
    370.4%
    Mild
    0
    0%
    0
    0%
    0
    0%
    Moderate
    0
    0%
    0
    0%
    0
    0%
    Severe
    0
    0%
    0
    0%
    0
    0%
    72. Primary Outcome
    Title Percentage of Subjects in Irritation Score Category for Uvula/Oropharynx at Day 25
    Description The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).
    Time Frame Day 25

    Outcome Measure Data

    Analysis Population Description
    Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.
    Arm/Group Title 19292-116-A Control (Listerine®) 12027-019 12027-020
    Arm/Group Description Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL) 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
    Measure Participants 26 26 23
    None
    100
    370.4%
    100
    384.6%
    100
    370.4%
    Mild
    0
    0%
    0
    0%
    0
    0%
    Moderate
    0
    0%
    0
    0%
    0
    0%
    Severe
    0
    0%
    0
    0%
    0
    0%

    Adverse Events

    Time Frame Day 25, +30 days for serious adverse events.
    Adverse Event Reporting Description Adverse events were systematically collected at each study visit through Visit 8 (Day 25). Serious adverse events were reported through 30 days after product use. Spontaneously reported adverse events collected outside of the regularly scheduled visits were also recorded.
    Arm/Group Title 19292-116-A Control (Listerine®) 12027-019 12027-020
    Arm/Group Description Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL) 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
    All Cause Mortality
    19292-116-A Control (Listerine®) 12027-019 12027-020
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN) / (NaN)
    Serious Adverse Events
    19292-116-A Control (Listerine®) 12027-019 12027-020
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/27 (0%) 0/26 (0%) 0/27 (0%)
    Other (Not Including Serious) Adverse Events
    19292-116-A Control (Listerine®) 12027-019 12027-020
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/27 (0%) 0/26 (0%) 0/27 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    Principal investigator agreed not to publish the study results without prior sponsor approval.

    Results Point of Contact

    Name/Title Michael Lynch, DMD, PhD/Study Director
    Organization Johnson & Johnson Consumer and Personal Products Worldwide
    Phone 908-433-6423 USA EST
    Email mlynch23@its.jnj.com
    Responsible Party:
    Johnson & Johnson Consumer and Personal Products Worldwide
    ClinicalTrials.gov Identifier:
    NCT01156376
    Other Study ID Numbers:
    • KOXDHY0003
    First Posted:
    Jul 2, 2010
    Last Update Posted:
    Aug 24, 2015
    Last Verified:
    Aug 1, 2015