3M Oral Rinse Evaluation of Incidence and Patient Acceptance of Sloughing When Used With Sodium Lauryl Sulfate (SLS) Toothpastes
Overview
- Phase
- Not Applicable
- Intervention
- Anti-plaque
- Conditions
- Oral Mucosal Disorder
- Sponsor
- Solventum US LLC
- Enrollment
- 53
- Locations
- 1
- Primary Endpoint
- Number of Participants With Oral Mucosal Exfoliation (Oral Sloughing)
- Status
- Terminated
- Last Updated
- last year
Overview
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.
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
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •A member of the Medical Clinical Affairs (MCA) staff or Panda product team for the device under investigation;
- •Have a dental appointment scheduled during study duration for professional cleaning;
- •Is pregnant, nursing, or planning to become pregnant within the study duration;
- •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);
- •History of using a prescription antimicrobial mouth rinse during the past 3 months;
- •Currently taking medications which may alter gingival appearance/bleeding;
- •Currently using anticonvulsants, calcium channel blockers, or other medications with side effects known to impact oral health;
- •Participation in any other clinical study within the last 30 days;
- •Resides in the same household with a subject already enrolled in the study;
- •Known history of sensitivity to oral hygiene products;
Arms & Interventions
Comparator: No SLS Toothpaste
3M Oral Rinse in combination with no SLS toothpaste (A)
Intervention: Anti-plaque
Comparator: No SLS Toothpaste
3M Oral Rinse in combination with no SLS toothpaste (A)
Intervention: No SLS toothpaste
Comparator: Medium SLS Toothpaste
3M Oral Rinse in combination with medium SLS toothpaste (B)
Intervention: Medium SLS toothpaste
Comparator: Medium SLS Toothpaste
3M Oral Rinse in combination with medium SLS toothpaste (B)
Intervention: Anti-plaque
Comparator: High SLS Toothpaste
3M Oral Rinse in combination with high SLS toothpaste (C)
Intervention: High SLS toothpaste
Comparator: High SLS Toothpaste
3M Oral Rinse in combination with high SLS toothpaste (C)
Intervention: Anti-plaque
Outcomes
Primary Outcomes
Number of Participants With Oral Mucosal Exfoliation (Oral Sloughing)
Time Frame: End of treatment (3 weeks)
Percentage of participants who experienced oral sloughing as reported either by the subject or determined by the dental evaluator.
Secondary Outcomes
- The Number of Participants With a Given Range of Average Oral Mucosal Sloughing Index Scores(Mid-Treatment (10 days))
- The Number of Participants With a Given Range of Average Oral Mucosal Sloughing Index Scores.(End of Treatment (3 weeks))