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

Not Applicable

Terminated

Conditions: Oral Mucosal Disorder

Interventions: Drug: No SLS toothpaste
Drug: Medium SLS toothpaste
Drug: High SLS toothpaste
Device: Anti-plaque

Registration Number: NCT04601103

Lead Sponsor: Solventum US LLC

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

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 53

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;
Currently using tobacco products (cigarettes, chewing tobacco) or vaping products (ecigarettes);
History of diabetes;
Have removable partial/full dentures;
Have orthodontic appliances;
Have medical or oral conditions that may compromise the subject's safety or interfere with the conduct and outcome of the study;
Have known sloughing within the last 3 weeks;
Have dry mouth;
Have widespread caries or chronic neglect;
Have gross pathological changes of oral soft tissues;
Have advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive alveolar bone loss);
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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Comparator: No SLS Toothpaste	No SLS toothpaste	3M Oral Rinse in combination with no SLS toothpaste (A)
Comparator: Medium SLS Toothpaste	Medium SLS toothpaste	3M Oral Rinse in combination with medium SLS toothpaste (B)
Comparator: High SLS Toothpaste	High SLS toothpaste	3M Oral Rinse in combination with high SLS toothpaste (C)
Comparator: No SLS Toothpaste	Anti-plaque	3M Oral Rinse in combination with no SLS toothpaste (A)
Comparator: High SLS Toothpaste	Anti-plaque	3M Oral Rinse in combination with high SLS toothpaste (C)
Comparator: Medium SLS Toothpaste	Anti-plaque	3M Oral Rinse in combination with medium SLS toothpaste (B)

Primary Outcome Measures

Name	Time	Method
Number of Participants With Oral Mucosal Exfoliation (Oral Sloughing)	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 Outcome Measures

Name	Time	Method
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)
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)