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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Oral Mucosal Disorder

Intervention / Treatment
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* Drug: No SLS toothpaste
* Drug: Medium SLS toothpaste
* Drug: High SLS toothpaste
* Device: Anti-plaque


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Able to understand and willing to sign the informed consent; Willing to agree to maintain confidentiality of the study and study materials; 3M employee aged 18 years and older; Willing to return to the study facility for scheduled study visits and recalls; Agree not to use other oral hygiene products (non-study toothpaste, non-study toothbrush, mouth rinse, chewing gum); Agree to the study instruction and schedule 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Oral Mucosal Exfoliation (Oral Sloughing) | Percentage of participants who experienced oral sloughing as reported either by the subject or determined by the dental evaluator. | End of treatment (3 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Number of Participants With a Given Range of Average Oral Mucosal Sloughing Index Scores | 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) | Mid-Treatment (10 days) | 
| The Number of Participants With a Given Range of Average Oral Mucosal Sloughing Index Scores. | 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) | End of Treatment (3 weeks) |