3M Oral Rinse Incidence and Patient Acceptance of Sloughing When Used With Sodium Lauryl Sulfate (SLS) Toothpastes

• Sponsor: 3M (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT04601103
• Collaborator: (none)
• Enrollment: 53
• Location: 1
• Arms: 3
• Actual Duration (Months): 2.1
• Patients Per Site Per Month: 25.2

Study Details

Study Description

Brief Summary

The primary objective of this study is to evaluate the incidence of oral tissue sloughing through self-report by study subjects and by professional dental examinations.

Condition or Disease	Intervention/Treatment	Phase
Oral Mucosal Disorder	Drug: No SLS toothpaste; Drug: Medium SLS toothpaste; Drug: High SLS toothpaste; Device: Anti-plaque

Detailed Description

The primary objective of this study is to evaluate the incidence of oral tissue sloughing through self-report by study subjects and by professional dental examinations. Adverse events will be tracked through study dental examinations and subject diaries with twice daily use of the 3M Oral Rinse used in combination with toothpaste containing one of three levels (no, medium, high) of Sodium Lauryl Sulfate (SLS).

Determine the subjects' acceptance of sloughing and/or other side effects

Study Design

• Study Type: Interventional
• Actual Enrollment: 53 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: The study was designed as an imbalanced 2 Period Crossover Study. However, the study was terminated during the washout period and the results reported here reflect only the period 1 results.The study was designed as an imbalanced 2 Period Crossover Study. However, the study was terminated during the washout period and the results reported here reflect only the period 1 results.
• Masking: Single (Outcomes Assessor)
• Masking Description: Assessors did not know what toothpaste subjects used.
• Primary Purpose: Basic Science
• Official Title: 3M Oral Rinse Evaluation of Incidence and Patient Acceptance of Sloughing When Used With Sodium Lauryl Sulfate (SLS) Toothpastes
• Actual Study Start Date: Jan 6, 2020
• Actual Primary Completion Date: Mar 10, 2020
• Actual Study Completion Date: Mar 10, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Comparator: No SLS Toothpaste 3M Oral Rinse in combination with no SLS toothpaste (A)	Drug: No SLS toothpaste; Toothpaste no Sodium Lauryl Sulfate; Other Names: Sensodyne ProNamel Fresh Breath Toothpaste ; Device: Anti-plaque; Rinse prevents bacterial adherence to teeth; Other Names: 3M Oral Rinse
Experimental: Comparator: Medium SLS Toothpaste 3M Oral Rinse in combination with medium SLS toothpaste (B)	Drug: Medium SLS toothpaste; Less than or equal to X ppm Sodium Lauryl Sulfate; Other Names: Clinpro Tooth Creme ; Device: Anti-plaque; Rinse prevents bacterial adherence to teeth; Other Names: 3M Oral Rinse
Experimental: Comparator: High SLS Toothpaste 3M Oral Rinse in combination with high SLS toothpaste (C)	Drug: High SLS toothpaste; More than or equal to X ppm Sodium Lauryl Sulfate; Other Names: Colgate Cavity Protection Toothpaste ; Device: Anti-plaque; Rinse prevents bacterial adherence to teeth; Other Names: 3M Oral Rinse

Outcome Measures

Primary Outcome Measures

1. Number of Participants With a Reported Oral Mucosal Exfoliation Adverse Event (Oral Sloughing Incidence) [End of treatment (3 weeks)]

   Evaluation of incidence rate of oral sloughing as assessed by the subject and/or assessor

Secondary Outcome Measures

1. The Number of Participants With a Given Range of Average Oral Mucosal Sloughing Index Scores [Mid-Treatment (10 days)]

   Average score based on the mean of sloughing scores over 12 intra-oral areas. The sloughing score uses a 6 point scale as follows: 0= no sloughing, 1=flecks of desquamation, 2=sheets of desquamation, 3=redness, not due to plaque, 4=erosion of mucosa, 5=ulcerated areas. The twelve intra-oral areas of the mouth are as follows: dorsal and ventral surfaces of the tongue, floor and roof of the mouth, right and left buccal mucosa, gingival tissue. (upper right, upper anterior, upper left, lower left, lower anterior, lower right)

2. The Number of Participants With a Given Range of Average Oral Mucosal Sloughing Index Scores. [End of Treatment (3 weeks)]

   Average score based on the mean of sloughing scores over 12 intra-oral areas. The sloughing score uses a 6 point scale as follows: 0= no sloughing, 1=flecks of desquamation, 2=sheets of desquamation, 3=redness, not due to plaque, 4=erosion of mucosa, 5=ulcerated areas. The twelve intra-oral areas of the mouth are as follows: dorsal and ventral surfaces of the tongue, floor and roof of the mouth, right and left buccal mucosa, gingival tissue. (upper right, upper anterior, upper left, lower left, lower anterior, lower right)

Other Outcome Measures

1. The Number of Participants Reporting Their Acceptance Levels of Side Effects [End of Treatment (3 weeks)]

   Subjects were questioned regarding how acceptable were your side effects. Using the following responses of: Completely unacceptable, somewhat unacceptable, somewhat acceptable, completely acceptable, did not experience side effects

Eligibility Criteria

Criteria

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

Inclusion Criteria

1. Able to understand and willing to sign the informed consent;

2. Willing to agree to maintain confidentiality of the study and study materials;

3. 3M employee aged 18 years and older;

4. Willing to return to the study facility for scheduled study visits and recalls;

5. Agree not to use other oral hygiene products (non-study toothpaste, non-study toothbrush, mouth rinse, chewing gum);

6. Agree to the study instruction and schedule

Exclusion Criteria:

1. A member of the Medical Clinical Affairs (MCA) staff or Panda product team for the device under investigation;

2. Have a dental appointment scheduled during study duration for professional cleaning;

3. Is pregnant, nursing, or planning to become pregnant within the study duration;

4. History of antibiotic therapy within the previous 30 days or have a condition that is likely to need antibiotic treatment over the course of the study (e.g., cardiac conditions requiring antibiotic prophylaxis such as heart murmurs, pacemakers, or prosthetic heart valves and prosthetic implants);

5. History of using a prescription antimicrobial mouth rinse during the past 3 months;

6. Currently taking medications which may alter gingival appearance/bleeding;

7. Currently using anticonvulsants, calcium channel blockers, or other medications with side effects known to impact oral health;

8. Participation in any other clinical study within the last 30 days;

9. Resides in the same household with a subject already enrolled in the study;

10. Known history of sensitivity to oral hygiene products;

11. Currently using tobacco products (cigarettes, chewing tobacco) or vaping products (ecigarettes);

12. History of diabetes;

13. Have removable partial/full dentures;

14. Have orthodontic appliances;

15. Have medical or oral conditions that may compromise the subject's safety or interfere with the conduct and outcome of the study;

16. Have known sloughing within the last 3 weeks;

17. Have dry mouth;

18. Have widespread caries or chronic neglect;

19. Have gross pathological changes of oral soft tissues;

20. Have advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive alveolar bone loss);

21. Unsuitable for enrollment in this study based on the professional opinion of the dental examiner based on the oral exam or other reasons not specified in the protocol

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	3M Health Care	Saint Paul	Minnesota	United States	55144

Sponsors and Collaborators

• 3M

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jan 7, 2020

More Information

Publications

None provided.

• Responsible Party: 3M
• ClinicalTrials.gov Identifier: NCT04601103
• Other Study ID Numbers: EM-11-050043
• First Posted: Oct 23, 2020
• Last Update Posted: Nov 19, 2021
• Last Verified: Oct 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No

Study Results

Participant Flow

Arm/Group Title	Comparator: No SLS Toothpaste	Comparator: Medium SLS Toothpaste	Comparator: High SLS Toothpaste
Arm/Group Description	3M Oral Rinse in combination with no SLS toothpaste (A) No SLS toothpaste: Toothpaste no Sodium Lauryl Phosphate Anti-plaque: Rinse prevents bacterial adherence to teeth	3M Oral Rinse in combination with medium SLS toothpaste (B) Medium SLS toothpaste: Less than or equal to X ppm Sodium Lauryl Phosphate Anti-plaque: Rinse prevents bacterial adherence to teeth	3M Oral Rinse in combination with high SLS toothpaste (C) High SLS toothpaste: More than or equal to X ppm Sodium Lauryl Phosphate Anti-plaque: Rinse prevents bacterial adherence to teeth
Period Title: Overall Study
STARTED	18	18	17
COMPLETED	0	0	0
NOT COMPLETED	18	18	17

Baseline Characteristics

Arm/Group Title	Comparator: No SLS Toothpaste	Comparator: Medium SLS Toothpaste	Comparator: High SLS Toothpaste	Total
Arm/Group Description	3M Oral Rinse in combination with no SLS toothpaste (A) No SLS toothpaste: Toothpaste no Sodium Lauryl Phosphate Anti-plaque: Rinse prevents bacterial adherence to teeth	3M Oral Rinse in combination with medium SLS toothpaste (B) Medium SLS toothpaste: Less than or equal to X ppm Sodium Lauryl Phosphate Anti-plaque: Rinse prevents bacterial adherence to teeth	3M Oral Rinse in combination with high SLS toothpaste (C) High SLS toothpaste: More than or equal to X ppm Sodium Lauryl Phosphate Anti-plaque: Rinse prevents bacterial adherence to teeth	Total of all reporting groups
Overall Participants	18	18	17	53
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	43.2 (10.3)	39.7 (12.09)	38.5 (11.82)	40.5 (11.38)
Sex: Female, Male (Count of Participants)
Female	11 61.1%	11 61.1%	9 52.9%	31 58.5%
Male	7 38.9%	7 38.9%	8 47.1%	22 41.5%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	2 11.1%	0 0%	1 5.9%	3 5.7%
Not Hispanic or Latino	16 88.9%	18 100%	16 94.1%	50 94.3%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%
Asian	0 0%	1 5.6%	0 0%	1 1.9%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%	0 0%
White	18 100%	17 94.4%	17 100%	52 98.1%
More than one race	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%
Region of Enrollment (Count of Participants)
United States	18 100%	18 100%	17 100%	53 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With a Reported Oral Mucosal Exfoliation Adverse Event (Oral Sloughing Incidence)
Description	Evaluation of incidence rate of oral sloughing as assessed by the subject and/or assessor
Time Frame	End of treatment (3 weeks)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Comparator: No SLS Toothpaste	Comparator: Medium SLS Toothpaste	Comparator: High SLS Toothpaste
Arm/Group Description	3M Oral Rinse in combination with no SLS toothpaste (A) No SLS toothpaste: Toothpaste no Sodium Lauryl Phosphate Anti-plaque: Rinse prevents bacterial adherence to teeth	3M Oral Rinse in combination with medium SLS toothpaste (B) Medium SLS toothpaste: Less than or equal to X ppm Sodium Lauryl Phosphate Anti-plaque: Rinse prevents bacterial adherence to teeth	3M Oral Rinse in combination with high SLS toothpaste (C) High SLS toothpaste: More than or equal to X ppm Sodium Lauryl Phosphate Anti-plaque: Rinse prevents bacterial adherence to teeth
Measure Participants	18	18	17
Count of Participants [Participants]	15 83.3%	14 77.8%	13 76.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Comparator: No SLS Toothpaste, Comparator: Medium SLS Toothpaste, Comparator: High SLS Toothpaste
	Comments
	Type of Statistical Test	Other
	Comments	Generalized Fisher's Exact Test was used to detect an association between the 3 treatment groups and the incidence of sloughing
Statistical Test of Hypothesis	p-Value	.916
	Comments
	Method	Fisher Exact
	Comments

2. Secondary Outcome

Title	The Number of Participants With a Given Range of Average Oral Mucosal Sloughing Index Scores
Description	Average score based on the mean of sloughing scores over 12 intra-oral areas. The sloughing score uses a 6 point scale as follows: 0= no sloughing, 1=flecks of desquamation, 2=sheets of desquamation, 3=redness, not due to plaque, 4=erosion of mucosa, 5=ulcerated areas. The twelve intra-oral areas of the mouth are as follows: dorsal and ventral surfaces of the tongue, floor and roof of the mouth, right and left buccal mucosa, gingival tissue. (upper right, upper anterior, upper left, lower left, lower anterior, lower right)
Time Frame	Mid-Treatment (10 days)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Comparator: No SLS Toothpaste	Comparator: Medium SLS Toothpaste	Comparator: High SLS Toothpaste
Arm/Group Description	3M Oral Rinse in combination with no SLS toothpaste (A) No SLS toothpaste: Toothpaste no Sodium Lauryl Phosphate Anti-plaque: Rinse prevents bacterial adherence to teeth	3M Oral Rinse in combination with medium SLS toothpaste (B) Medium SLS toothpaste: Less than or equal to X ppm Sodium Lauryl Phosphate Anti-plaque: Rinse prevents bacterial adherence to teeth	3M Oral Rinse in combination with high SLS toothpaste (C) High SLS toothpaste: More than or equal to X ppm Sodium Lauryl Phosphate Anti-plaque: Rinse prevents bacterial adherence to teeth
Measure Participants	18	18	16
0 no sloughing	8 44.4%	6 33.3%	7 41.2%
(0.0, 0.5]	9 50%	8 44.4%	6 35.3%
(0.5, 1.0]	1 5.6%	3 16.7%	2 11.8%
(1.0, 1.5]	0 0%	0 0%	1 5.9%
(1.5, 2.0]	0 0%	1 5.6%	0 0%

3. Secondary Outcome

Title	The Number of Participants With a Given Range of Average Oral Mucosal Sloughing Index Scores.
Description	Average score based on the mean of sloughing scores over 12 intra-oral areas. The sloughing score uses a 6 point scale as follows: 0= no sloughing, 1=flecks of desquamation, 2=sheets of desquamation, 3=redness, not due to plaque, 4=erosion of mucosa, 5=ulcerated areas. The twelve intra-oral areas of the mouth are as follows: dorsal and ventral surfaces of the tongue, floor and roof of the mouth, right and left buccal mucosa, gingival tissue. (upper right, upper anterior, upper left, lower left, lower anterior, lower right)
Time Frame	End of Treatment (3 weeks)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Comparator: No SLS Toothpaste	Comparator: Medium SLS Toothpaste	Comparator: High SLS Toothpaste
Arm/Group Description	3M Oral Rinse in combination with no SLS toothpaste (A) No SLS toothpaste: Toothpaste no Sodium Lauryl Phosphate Anti-plaque: Rinse prevents bacterial adherence to teeth	3M Oral Rinse in combination with medium SLS toothpaste (B) Medium SLS toothpaste: Less than or equal to X ppm Sodium Lauryl Phosphate Anti-plaque: Rinse prevents bacterial adherence to teeth	3M Oral Rinse in combination with high SLS toothpaste (C) High SLS toothpaste: More than or equal to X ppm Sodium Lauryl Phosphate Anti-plaque: Rinse prevents bacterial adherence to teeth
Measure Participants	18	18	16
0 No sloughing	6 33.3%	9 50%	7 41.2%
(0.0, 0.5]	9 50%	6 33.3%	6 35.3%
(0.5, 1.0]	3 16.7%	2 11.1%	2 11.8%
(1.0, 1.5]	0 0%	1 5.6%	1 5.9%

4. Other Pre-specified Outcome

Title	The Number of Participants Reporting Their Acceptance Levels of Side Effects
Description	Subjects were questioned regarding how acceptable were your side effects. Using the following responses of: Completely unacceptable, somewhat unacceptable, somewhat acceptable, completely acceptable, did not experience side effects
Time Frame	End of Treatment (3 weeks)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Comparator: No SLS Toothpaste	Comparator: Medium SLS Toothpaste	Comparator: High SLS Toothpaste
Arm/Group Description	3M Oral Rinse in combination with no SLS toothpaste (A) No SLS toothpaste: Toothpaste no Sodium Lauryl Phosphate Anti-plaque: Rinse prevents bacterial adherence to teeth	3M Oral Rinse in combination with medium SLS toothpaste (B) Medium SLS toothpaste: Less than or equal to X ppm Sodium Lauryl Phosphate Anti-plaque: Rinse prevents bacterial adherence to teeth	3M Oral Rinse in combination with high SLS toothpaste (C) High SLS toothpaste: More than or equal to X ppm Sodium Lauryl Phosphate Anti-plaque: Rinse prevents bacterial adherence to teeth
Measure Participants	18	18	17
Completely unacceptable	2 11.1%	1 5.6%	2 11.8%
Somewhat unacceptable	2 11.1%	0 0%	1 5.9%
Somewhat acceptable	1 5.6%	4 22.2%	4 23.5%
Completely acceptable	1 5.6%	4 22.2%	3 17.6%
Did not experience side effects	12 66.7%	9 50%	7 41.2%

Adverse Events

Time Frame	Within 3 weeks of starting treatment
Arm/Group Title	Comparator: No SLS Toothpaste		Comparator: Medium SLS Toothpaste		Comparator: High SLS Toothpaste
Arm/Group Description	3M Oral Rinse in combination with no SLS toothpaste (A) No SLS toothpaste: Toothpaste no Sodium Lauryl Phosphate Anti-plaque: Rinse prevents bacterial adherence to teeth		3M Oral Rinse in combination with medium SLS toothpaste (B) Medium SLS toothpaste: Less than or equal to X ppm Sodium Lauryl Phosphate Anti-plaque: Rinse prevents bacterial adherence to teeth		3M Oral Rinse in combination with high SLS toothpaste (C) High SLS toothpaste: More than or equal to X ppm Sodium Lauryl Phosphate Anti-plaque: Rinse prevents bacterial adherence to teeth
All Cause Mortality
	Comparator: No SLS Toothpaste		Comparator: Medium SLS Toothpaste		Comparator: High SLS Toothpaste
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/18 (0%)		0/18 (0%)		0/17 (0%)
Serious Adverse Events
	Comparator: No SLS Toothpaste		Comparator: Medium SLS Toothpaste		Comparator: High SLS Toothpaste
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/18 (0%)		0/18 (0%)		0/17 (0%)
Other (Not Including Serious) Adverse Events
	Comparator: No SLS Toothpaste		Comparator: Medium SLS Toothpaste		Comparator: High SLS Toothpaste
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	15/18 (83.3%)		15/18 (83.3%)		16/17 (94.1%)
Gastrointestinal disorders
Aphthous ulcer	1/18 (5.6%)	1	0/18 (0%)	0	0/17 (0%)	0
Breath odor	0/18 (0%)	0	0/18 (0%)	0	1/17 (5.9%)	1
Buccal mucosal roughening	1/18 (5.6%)	1	0/18 (0%)	0	0/17 (0%)	0
Dry mouth	3/18 (16.7%)	3	1/18 (5.6%)	1	3/17 (17.6%)	3
Dysgeusia	2/18 (11.1%)	2	2/18 (11.1%)	2	1/17 (5.9%)	1
Dyspepsia	0/18 (0%)	0	0/18 (0%)	0	1/17 (5.9%)	1
Glossitis	0/18 (0%)	0	0/18 (0%)	0	1/17 (5.9%)	1
Hyperaesthesia teeth	0/18 (0%)	0	1/18 (5.6%)	1	0/17 (0%)	0
Hypoaesthesia oral	1/18 (5.6%)	1	1/18 (5.6%)	1	2/17 (11.8%)	3
Mouth injury	0/18 (0%)	0	2/18 (11.1%)	2	1/17 (5.9%)	1
Oral discomfort	1/18 (5.6%)	1	0/18 (0%)	0	1/17 (5.9%)	1
Oral mucosal exfoliation	15/18 (83.3%)	15	14/18 (77.8%)	14	13/17 (76.5%)	13
Oral pain	1/18 (5.6%)	1	0/18 (0%)	0	0/17 (0%)	0
Salivary hypersecretion	1/18 (5.6%)	1	0/18 (0%)	0	0/17 (0%)	0
Sensitivity of teeth	0/18 (0%)	0	0/18 (0%)	0	1/17 (5.9%)	1
Stomatitis	0/18 (0%)	0	1/18 (5.6%)	1	1/17 (5.9%)	1
Tongue biting	1/18 (5.6%)	1	0/18 (0%)	0	0/17 (0%)	0
Tongue exfoliation	0/18 (0%)	0	0/18 (0%)	0	1/17 (5.9%)	1
Infections and infestations
Nasopharyngitis	0/18 (0%)	0	0/18 (0%)	0	1/17 (5.9%)	1
Musculoskeletal and connective tissue disorders
Ligament sprain	1/18 (5.6%)	1	0/18 (0%)	0	0/17 (0%)	0
Product Issues
Device failure	1/18 (5.6%)	1	0/18 (0%)	0	0/17 (0%)	0

Limitations/Caveats

The major limitation with this study is that the sample size goal was not reached given the early termination during the washout period of a two-period crossover design.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.