Clinical trial NCT04601103: 3M Oral Rinse Incidence and Patient Acceptance of Sloughing When Used With Sodium Lauryl Sulfate (SLS) Toothpastes
Official title: 3M Oral Rinse Evaluation of Incidence and Patient Acceptance of Sloughing When Used With Sodium Lauryl Sulfate (SLS) Toothpastes
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Oral Mucosal Disorder
Lead sponsor: Solventum US LLC
Sponsor class: INDUSTRY
Collaborators: name: 3M
First posted: 2020-10-23
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: BASIC_SCIENCE

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

Eligibility criteria: 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:
7. A member of the Medical Clinical Affairs (MCA) staff or Panda product team for the device under investigation;
8. Have a dental appointment scheduled during study duration for professional cleaning;
9. Is pregnant, nursing, or planning to become pregnant within the study duration;
10. 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);
11. History of using a prescription antimicrobial mouth rinse during the past 3 months;
12. Currently taking medications which may alter gingival appearance/bleeding;
13. Currently using anticonvulsants, calcium channel blockers, or other medications with side effects known to impact oral health;
14. Participation in any other clinical study within the last 30 days;
15. Resides in the same household with a subject already enrolled in the study;
16. Known history of sensitivity to oral hygiene products;
17. Currently using tobacco products (cigarettes, chewing tobacco) or vaping products (ecigarettes);
18. History of diabetes;
19. Have removable partial/full dentures;
20. Have orthodontic appliances;
21. Have medical or oral conditions that may compromise the subject's safety or interfere with the conduct and outcome of the study;
22. Have known sloughing within the last 3 weeks;
23. Have dry mouth;
24. Have widespread caries or chronic neglect;
25. Have gross pathological changes of oral soft tissues;
26. Have advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive alveolar bone loss);
27. 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

Primary outcomes:
measure: Number of Participants With Oral Mucosal Exfoliation (Oral Sloughing)
timeFrame: End of treatment (3 weeks)
Secondary outcomes:
measure: The Number of Participants With a Given Range of Average Oral Mucosal Sloughing Index Scores
timeFrame: Mid-Treatment (10 days)
measure: The Number of Participants With a Given Range of Average Oral Mucosal Sloughing Index Scores.
timeFrame: End of Treatment (3 weeks)
Other outcomes:
measure: The Number of Participants Reporting Their Acceptance Levels of Side Effects
timeFrame: End of Treatment (3 weeks)
Locations:
city: Saint Paul
country: United States
facility: 3M Health Care
state: Minnesota
Study officials:
affiliation: 3M Health Care Business Group
name: Brenda C Coalwell, BA
role: PRINCIPAL_INVESTIGATOR
References: