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

NCT04601103 | Terminated Results FDA Device

• 1 other identifier: EM-11-050043
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

Oral Mucosal Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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)

Other Outcomes (1)

• The Number of Participants Reporting Their Acceptance Levels of Side Effects

  End of Treatment (3 weeks)

Study Arms (3)

Comparator: No SLS Toothpaste

EXPERIMENTAL

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

Drug: No SLS toothpaste; Device: Anti-plaque

Comparator: Medium SLS Toothpaste

EXPERIMENTAL

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

Drug: Medium SLS toothpaste; Device: Anti-plaque

Comparator: High SLS Toothpaste

EXPERIMENTAL

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

Drug: High SLS toothpaste; Device: Anti-plaque

Interventions

No SLS toothpaste DRUG

Toothpaste no Sodium Lauryl Sulfate

Also known as: Sensodyne ProNamel Fresh Breath Toothpaste

Comparator: No SLS Toothpaste

Medium SLS toothpaste DRUG

Less than or equal to X ppm Sodium Lauryl Sulfate

Also known as: Clinpro Tooth Creme

Comparator: Medium SLS Toothpaste

High SLS toothpaste DRUG

More than or equal to X ppm Sodium Lauryl Sulfate

Also known as: Colgate Cavity Protection Toothpaste

Comparator: High SLS Toothpaste

Anti-plaque DEVICE

Rinse prevents bacterial adherence to teeth

Also known as: 3M Oral Rinse

Comparator: High SLS Toothpaste; Comparator: Medium SLS Toothpaste; Comparator: No SLS Toothpaste

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to understand and willing to sign the informed consent;
• Willing to agree to maintain confidentiality of the study and study materials;
• M 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Solventum US LLC: lead
• 3M: collaborator

Study Sites (1)

3M Health Care

Saint Paul, Minnesota, 55144, United States

Location

Limitations and Caveats

The major limitation with this study is that the sample size goal was not reached given the early termination during the washout period of a two-period crossover design.

Results Point of Contact

• Title: Brenda Coalwell, Clinical Affairs Manager
• Organization: 3M Health Care Business Group

bccoalwell1@mmm.com

16517362456

Study Officials

• Brenda C Coalwell, BA

  3M Health Care Business Group

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessors did not know what toothpaste subjects used.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 13, 2020
• First Posted: October 23, 2020
• Study Start: January 6, 2020
• Primary Completion: March 10, 2020
• Study Completion: March 10, 2020
• Last Updated: October 1, 2024
• Results First Posted: November 19, 2021

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)