Effectiveness of Two Water-Based Potassium Oxalate Desensitizers on Dental Hypersensitivity
Study Details
Study Description
Brief Summary
This study will compare the safety and effectiveness of two water-based potassium oxalate desensitizers on existing dentinal hypersensitivity.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: potassium oxalate gel Professional application |
Device: Potassium oxalate
Professional application
|
| Active Comparator: Potassium oxalate liquid Professional application |
Device: Potassium oxalate
Professional application
|
Outcome Measures
Primary Outcome Measures
- Change From Baseline for Air Challenge [36 days]
The Schiff Sensitivity Scale was assessed for each test tooth via an evaporative air challenge. The examiner recorded the Schiff Index score corresponding to the response to the air challenge. The Schiff Index Sensitivity scale is scored as follows- 0: tooth/subject did not respond to stimulus, 1: tooth/subject responds to stimulus, but does not request discontinuation of stimulus, 2: tooth/subject responds to stimulus and requests discontinuation or moves form stimulus, 3: tooth/subject responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. The higher the Schiff score, the more sensitive the tooth. The mean change from Baseline was calculated for this measure.
Secondary Outcome Measures
- Change From Baseline in Dentin Sensitivity [36 days]
Visual Analog Scale (VAS) - subjects are asked to look at a VAS and designate the level of hypersensitivity they experienced as a result of the thermal and water challenges using a continuum scale of 0 = No tooth pain up to 100 = Worst tooth pain ever experienced.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Provide written informed consent to participate in the study
-
Be at least 18 years of age
-
Be in good general health, as determined by the Investigator/designee based on review of the health history/update for participation in the study
-
Agree to refrain from participating in any other oral/dental product studies for the duration of the study
-
Agree to refrain from receiving any elective dentistry (including dental prophylaxis) for the duration of the study
-
Agree to refrain from using any oral hygiene products other than the assigned study products for the duration of the study
-
Agree to comply with study/product usage instructions; and
-
Have at least one tooth with gingival recession and hypersensitivity evidenced by a score of ≥ 1 on the Cold Air Sensitivity Schiff scale during screening
Exclusion Criteria:
-
Gross oral neglect or urgent dental treatment needs
-
Severe periodontal disease and/or generalized mobility
-
Active treatment for periodontitis
-
Any disease or condition that could be expected to interfere with examination procedures or safe completion of the study
-
Self-reported pregnancy or nursing
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Tufts University School of Dental Medicine | Boston | Massachusetts | United States | 02111 |
Sponsors and Collaborators
- Procter and Gamble
Investigators
- Principal Investigator: Athena Papas, DMD, PhD, Tufts University School of Dental Medicine
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2013145
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Potassium Oxalate Gel | Potassium Oxalate Liquid |
|---|---|---|
| Arm/Group Description | Professional application Potassium oxalate: Professional application | Professional application Potassium oxalate: Professional application |
| Period Title: Overall Study | ||
| STARTED | 45 | 35 |
| COMPLETED | 44 | 34 |
| NOT COMPLETED | 1 | 1 |
Baseline Characteristics
| Arm/Group Title | Potassium Oxalate Gel | Potassium Oxalate Liquid | Total |
|---|---|---|---|
| Arm/Group Description | Professional application Potassium oxalate: Professional application | Professional application Potassium oxalate: Professional application | Total of all reporting groups |
| Overall Participants | 45 | 35 | 80 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
46.7
(13.26)
|
45.7
(13.72)
|
46.3
(13.39)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
23
51.1%
|
20
57.1%
|
43
53.8%
|
| Male |
22
48.9%
|
15
42.9%
|
37
46.3%
|
| Race/Ethnicity, Customized (Count of Participants) | |||
| Asian Indian |
2
4.4%
|
0
0%
|
2
2.5%
|
| Asian Oriental |
5
11.1%
|
4
11.4%
|
9
11.3%
|
| Black |
10
22.2%
|
11
31.4%
|
21
26.3%
|
| Caucasian |
22
48.9%
|
16
45.7%
|
38
47.5%
|
| Hispanic |
5
11.1%
|
3
8.6%
|
8
10%
|
| Multi-Racial |
1
2.2%
|
1
2.9%
|
2
2.5%
|
Outcome Measures
| Title | Change From Baseline for Air Challenge |
|---|---|
| Description | The Schiff Sensitivity Scale was assessed for each test tooth via an evaporative air challenge. The examiner recorded the Schiff Index score corresponding to the response to the air challenge. The Schiff Index Sensitivity scale is scored as follows- 0: tooth/subject did not respond to stimulus, 1: tooth/subject responds to stimulus, but does not request discontinuation of stimulus, 2: tooth/subject responds to stimulus and requests discontinuation or moves form stimulus, 3: tooth/subject responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. The higher the Schiff score, the more sensitive the tooth. The mean change from Baseline was calculated for this measure. |
| Time Frame | 36 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| Eighty (80) subjects received study products. Seventy-eight (78) subjects completed the study. Two subjects dropped from the study after the Day 6 visit. |
| Arm/Group Title | Potassium Oxalate Gel | Potassium Oxalate Liquid |
|---|---|---|
| Arm/Group Description | Professional application Potassium oxalate: Professional application | Professional application Potassium oxalate: Professional application |
| Measure Participants | 44 | 34 |
| Mean (Standard Error) [units on a scale] |
-1.18
(0.46)
|
-1.10
(0.56)
|
| Title | Change From Baseline in Dentin Sensitivity |
|---|---|
| Description | Visual Analog Scale (VAS) - subjects are asked to look at a VAS and designate the level of hypersensitivity they experienced as a result of the thermal and water challenges using a continuum scale of 0 = No tooth pain up to 100 = Worst tooth pain ever experienced. |
| Time Frame | 36 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| Eighty (80) subjects received product. Seventy-eight (78) subjects completed the study. Two subjects dropped from the study after the Day 6 visit. |
| Arm/Group Title | Potassium Oxalate Gel | Potassium Oxalate Liquid |
|---|---|---|
| Arm/Group Description | Professional application Potassium oxalate: Professional application | Professional application Potassium oxalate: Professional application |
| Measure Participants | 44 | 34 |
| Schiff Air Index |
-1.18
(0.46)
|
-1.10
(0.56)
|
| Visual Analog Scale |
-27.18
(21.10)
|
-30.57
(18.16)
|
Adverse Events
| Time Frame | 36 days | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Potassium Oxalate Gel | Potassium Oxalate Liquid | ||
| Arm/Group Description | Professional application Potassium oxalate: Professional application | Professional application Potassium oxalate: Professional application | ||
All Cause Mortality |
||||
| Potassium Oxalate Gel | Potassium Oxalate Liquid | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/45 (0%) | 0/35 (0%) | ||
Serious Adverse Events |
||||
| Potassium Oxalate Gel | Potassium Oxalate Liquid | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/45 (0%) | 0/35 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Potassium Oxalate Gel | Potassium Oxalate Liquid | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 2/45 (4.4%) | 1/35 (2.9%) | ||
| Gastrointestinal disorders | ||||
| Stomatitis | 1/45 (2.2%) | 0/35 (0%) | ||
| Tongue coated | 1/45 (2.2%) | 0/35 (0%) | ||
| Infections and infestations | ||||
| Gingival abscess | 0/45 (0%) | 1/35 (2.9%) | ||
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Written consent from Sponsor
Results Point of Contact
| Name/Title | Clinical Trial Manager |
|---|---|
| Organization | The Procter & Gamble Company |
| Phone | 513-622-2489 |
| peters.j.2@pg.com |
- 2013145