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

NCT ID: NCT04601103

Last Updated: 2024-10-01

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-06
• Study Completion Date: 2020-03-10

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

Conditions

Oral Mucosal Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Comparator: No SLS Toothpaste

3M Oral Rinse in combination with no SLS toothpaste (A)

Group Type: EXPERIMENTAL

No SLS toothpaste

Intervention Type: DRUG

Toothpaste no Sodium Lauryl Sulfate

Anti-plaque

Intervention Type: DEVICE

Rinse prevents bacterial adherence to teeth

Comparator: Medium SLS Toothpaste

3M Oral Rinse in combination with medium SLS toothpaste (B)

Group Type: EXPERIMENTAL

Medium SLS toothpaste

Intervention Type: DRUG

Less than or equal to X ppm Sodium Lauryl Sulfate

Anti-plaque

Intervention Type: DEVICE

Rinse prevents bacterial adherence to teeth

Comparator: High SLS Toothpaste

3M Oral Rinse in combination with high SLS toothpaste (C)

Group Type: EXPERIMENTAL

High SLS toothpaste

Intervention Type: DRUG

More than or equal to X ppm Sodium Lauryl Sulfate

Anti-plaque

Intervention Type: DEVICE

Rinse prevents bacterial adherence to teeth

Interventions

No SLS toothpaste

Toothpaste no Sodium Lauryl Sulfate

Intervention Type: DRUG

Medium SLS toothpaste

Less than or equal to X ppm Sodium Lauryl Sulfate

Intervention Type: DRUG

High SLS toothpaste

More than or equal to X ppm Sodium Lauryl Sulfate

Intervention Type: DRUG

Anti-plaque

Rinse prevents bacterial adherence to teeth

Intervention Type: DEVICE

Other Intervention Names

Sensodyne ProNamel Fresh Breath Toothpaste; Clinpro Tooth Creme; Colgate Cavity Protection Toothpaste; 3M Oral Rinse

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

3M

INDUSTRY

Sponsor Role: collaborator

Solventum US LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Brenda C Coalwell, BA

Role: PRINCIPAL_INVESTIGATOR

3M Health Care Business Group

Locations

3M Health Care

Saint Paul, Minnesota, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

EM-11-050043

Identifier Type: -

Identifier Source: org_study_id