Trial Outcomes & Findings for 3M Oral Rinse Incidence and Patient Acceptance of Sloughing When Used With Sodium Lauryl Sulfate (SLS) Toothpastes (NCT NCT04601103)
NCT ID: NCT04601103
Last Updated: 2024-10-01
Results Overview
Percentage of participants who experienced oral sloughing as reported either by the subject or determined by the dental evaluator.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
53 participants
Primary outcome timeframe
End of treatment (3 weeks)
Results posted on
2024-10-01
Participant Flow
Participant milestones
| Measure |
Comparator: No SLS Toothpaste
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
|
Comparator: Medium SLS Toothpaste
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
|
Comparator: High SLS Toothpaste
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
|
|---|---|---|---|
|
Overall Study
STARTED
|
18
|
18
|
17
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
18
|
18
|
17
|
Reasons for withdrawal
| Measure |
Comparator: No SLS Toothpaste
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
|
Comparator: Medium SLS Toothpaste
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
|
Comparator: High SLS Toothpaste
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
|
|---|---|---|---|
|
Overall Study
Needed crown & cleaning
|
0
|
0
|
1
|
|
Overall Study
study was terminated
|
18
|
18
|
16
|
Baseline Characteristics
3M Oral Rinse Incidence and Patient Acceptance of Sloughing When Used With Sodium Lauryl Sulfate (SLS) Toothpastes
Baseline characteristics by cohort
| Measure |
Comparator: No SLS Toothpaste
n=18 Participants
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
|
Comparator: Medium SLS Toothpaste
n=18 Participants
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
|
Comparator: High SLS Toothpaste
n=17 Participants
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
n=53 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
43.2 years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
39.7 years
STANDARD_DEVIATION 12.09 • n=7 Participants
|
38.5 years
STANDARD_DEVIATION 11.82 • n=5 Participants
|
40.5 years
STANDARD_DEVIATION 11.38 • n=4 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
50 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
52 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
18 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
53 Participants
n=4 Participants
|
|
Number of Participants with Oral Tissue Sloughing at Baseline
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: End of treatment (3 weeks)Percentage of participants who experienced oral sloughing as reported either by the subject or determined by the dental evaluator.
Outcome measures
| Measure |
Comparator: No SLS Toothpaste
n=18 Participants
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
|
Comparator: Medium SLS Toothpaste
n=18 Participants
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
|
Comparator: High SLS Toothpaste
n=17 Participants
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
|
|---|---|---|---|
|
Number of Participants With Oral Mucosal Exfoliation (Oral Sloughing)
|
15 Participants
|
14 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: 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)
Outcome measures
| Measure |
Comparator: No SLS Toothpaste
n=18 Participants
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
|
Comparator: Medium SLS Toothpaste
n=18 Participants
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
|
Comparator: High SLS Toothpaste
n=16 Participants
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
|
|---|---|---|---|
|
The Number of Participants With a Given Range of Average Oral Mucosal Sloughing Index Scores
0 no sloughing
|
8 Participants
|
6 Participants
|
7 Participants
|
|
The Number of Participants With a Given Range of Average Oral Mucosal Sloughing Index Scores
(0.0, 0.5]
|
9 Participants
|
8 Participants
|
6 Participants
|
|
The Number of Participants With a Given Range of Average Oral Mucosal Sloughing Index Scores
(0.5, 1.0]
|
1 Participants
|
3 Participants
|
2 Participants
|
|
The Number of Participants With a Given Range of Average Oral Mucosal Sloughing Index Scores
(1.0, 1.5]
|
0 Participants
|
0 Participants
|
1 Participants
|
|
The Number of Participants With a Given Range of Average Oral Mucosal Sloughing Index Scores
(1.5, 2.0]
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 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)
Outcome measures
| Measure |
Comparator: No SLS Toothpaste
n=18 Participants
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
|
Comparator: Medium SLS Toothpaste
n=18 Participants
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
|
Comparator: High SLS Toothpaste
n=16 Participants
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
|
|---|---|---|---|
|
The Number of Participants With a Given Range of Average Oral Mucosal Sloughing Index Scores.
0 No sloughing
|
6 Participants
|
9 Participants
|
7 Participants
|
|
The Number of Participants With a Given Range of Average Oral Mucosal Sloughing Index Scores.
(0.0, 0.5]
|
9 Participants
|
6 Participants
|
6 Participants
|
|
The Number of Participants With a Given Range of Average Oral Mucosal Sloughing Index Scores.
(0.5, 1.0]
|
3 Participants
|
2 Participants
|
2 Participants
|
|
The Number of Participants With a Given Range of Average Oral Mucosal Sloughing Index Scores.
(1.0, 1.5]
|
0 Participants
|
1 Participants
|
1 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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
Outcome measures
| Measure |
Comparator: No SLS Toothpaste
n=18 Participants
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
|
Comparator: Medium SLS Toothpaste
n=18 Participants
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
|
Comparator: High SLS Toothpaste
n=17 Participants
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
|
|---|---|---|---|
|
The Number of Participants Reporting Their Acceptance Levels of Side Effects
Completely unacceptable
|
2 Participants
|
1 Participants
|
2 Participants
|
|
The Number of Participants Reporting Their Acceptance Levels of Side Effects
Somewhat unacceptable
|
2 Participants
|
0 Participants
|
1 Participants
|
|
The Number of Participants Reporting Their Acceptance Levels of Side Effects
Somewhat acceptable
|
1 Participants
|
4 Participants
|
4 Participants
|
|
The Number of Participants Reporting Their Acceptance Levels of Side Effects
Completely acceptable
|
1 Participants
|
4 Participants
|
3 Participants
|
|
The Number of Participants Reporting Their Acceptance Levels of Side Effects
Did not experience side effects
|
12 Participants
|
9 Participants
|
7 Participants
|
Adverse Events
Comparator: No SLS Toothpaste
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Comparator: Medium SLS Toothpaste
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Comparator: High SLS Toothpaste
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Comparator: No SLS Toothpaste
n=18 participants at risk
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
|
Comparator: Medium SLS Toothpaste
n=18 participants at risk
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
|
Comparator: High SLS Toothpaste
n=17 participants at risk
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
|
|---|---|---|---|
|
Gastrointestinal disorders
Aphthous ulcer
|
5.6%
1/18 • Number of events 1 • Within 3 weeks of starting treatment
|
0.00%
0/18 • Within 3 weeks of starting treatment
|
0.00%
0/17 • Within 3 weeks of starting treatment
|
|
Gastrointestinal disorders
Breath odor
|
0.00%
0/18 • Within 3 weeks of starting treatment
|
0.00%
0/18 • Within 3 weeks of starting treatment
|
5.9%
1/17 • Number of events 1 • Within 3 weeks of starting treatment
|
|
Gastrointestinal disorders
Buccal mucosal roughening
|
5.6%
1/18 • Number of events 1 • Within 3 weeks of starting treatment
|
0.00%
0/18 • Within 3 weeks of starting treatment
|
0.00%
0/17 • Within 3 weeks of starting treatment
|
|
Gastrointestinal disorders
Dry mouth
|
16.7%
3/18 • Number of events 3 • Within 3 weeks of starting treatment
|
5.6%
1/18 • Number of events 1 • Within 3 weeks of starting treatment
|
17.6%
3/17 • Number of events 3 • Within 3 weeks of starting treatment
|
|
Gastrointestinal disorders
Dysgeusia
|
11.1%
2/18 • Number of events 2 • Within 3 weeks of starting treatment
|
11.1%
2/18 • Number of events 2 • Within 3 weeks of starting treatment
|
5.9%
1/17 • Number of events 1 • Within 3 weeks of starting treatment
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/18 • Within 3 weeks of starting treatment
|
0.00%
0/18 • Within 3 weeks of starting treatment
|
5.9%
1/17 • Number of events 1 • Within 3 weeks of starting treatment
|
|
Gastrointestinal disorders
Glossitis
|
0.00%
0/18 • Within 3 weeks of starting treatment
|
0.00%
0/18 • Within 3 weeks of starting treatment
|
5.9%
1/17 • Number of events 1 • Within 3 weeks of starting treatment
|
|
Gastrointestinal disorders
Hyperaesthesia teeth
|
0.00%
0/18 • Within 3 weeks of starting treatment
|
5.6%
1/18 • Number of events 1 • Within 3 weeks of starting treatment
|
0.00%
0/17 • Within 3 weeks of starting treatment
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
5.6%
1/18 • Number of events 1 • Within 3 weeks of starting treatment
|
5.6%
1/18 • Number of events 1 • Within 3 weeks of starting treatment
|
11.8%
2/17 • Number of events 3 • Within 3 weeks of starting treatment
|
|
Gastrointestinal disorders
Mouth injury
|
0.00%
0/18 • Within 3 weeks of starting treatment
|
11.1%
2/18 • Number of events 2 • Within 3 weeks of starting treatment
|
5.9%
1/17 • Number of events 1 • Within 3 weeks of starting treatment
|
|
Gastrointestinal disorders
Oral discomfort
|
5.6%
1/18 • Number of events 1 • Within 3 weeks of starting treatment
|
0.00%
0/18 • Within 3 weeks of starting treatment
|
5.9%
1/17 • Number of events 1 • Within 3 weeks of starting treatment
|
|
Gastrointestinal disorders
Oral mucosal exfoliation
|
83.3%
15/18 • Number of events 15 • Within 3 weeks of starting treatment
|
77.8%
14/18 • Number of events 14 • Within 3 weeks of starting treatment
|
76.5%
13/17 • Number of events 13 • Within 3 weeks of starting treatment
|
|
Gastrointestinal disorders
Oral pain
|
5.6%
1/18 • Number of events 1 • Within 3 weeks of starting treatment
|
0.00%
0/18 • Within 3 weeks of starting treatment
|
0.00%
0/17 • Within 3 weeks of starting treatment
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
5.6%
1/18 • Number of events 1 • Within 3 weeks of starting treatment
|
0.00%
0/18 • Within 3 weeks of starting treatment
|
0.00%
0/17 • Within 3 weeks of starting treatment
|
|
Gastrointestinal disorders
Sensitivity of teeth
|
0.00%
0/18 • Within 3 weeks of starting treatment
|
0.00%
0/18 • Within 3 weeks of starting treatment
|
5.9%
1/17 • Number of events 1 • Within 3 weeks of starting treatment
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/18 • Within 3 weeks of starting treatment
|
5.6%
1/18 • Number of events 1 • Within 3 weeks of starting treatment
|
5.9%
1/17 • Number of events 1 • Within 3 weeks of starting treatment
|
|
Gastrointestinal disorders
Tongue biting
|
5.6%
1/18 • Number of events 1 • Within 3 weeks of starting treatment
|
0.00%
0/18 • Within 3 weeks of starting treatment
|
0.00%
0/17 • Within 3 weeks of starting treatment
|
|
Gastrointestinal disorders
Tongue exfoliation
|
0.00%
0/18 • Within 3 weeks of starting treatment
|
0.00%
0/18 • Within 3 weeks of starting treatment
|
5.9%
1/17 • Number of events 1 • Within 3 weeks of starting treatment
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/18 • Within 3 weeks of starting treatment
|
0.00%
0/18 • Within 3 weeks of starting treatment
|
5.9%
1/17 • Number of events 1 • Within 3 weeks of starting treatment
|
|
Musculoskeletal and connective tissue disorders
Ligament sprain
|
5.6%
1/18 • Number of events 1 • Within 3 weeks of starting treatment
|
0.00%
0/18 • Within 3 weeks of starting treatment
|
0.00%
0/17 • Within 3 weeks of starting treatment
|
|
Product Issues
Device failure
|
5.6%
1/18 • Number of events 1 • Within 3 weeks of starting treatment
|
0.00%
0/18 • Within 3 weeks of starting treatment
|
0.00%
0/17 • Within 3 weeks of starting treatment
|
Additional Information
Brenda Coalwell, Clinical Affairs Manager
3M Health Care Business Group
Phone: 16517362456
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place