Trials Sponsors Conditions Drugs Pricing

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 toothpasteDevice: Anti-plaque

Comparator: Medium SLS Toothpaste

EXPERIMENTAL

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

Drug: Medium SLS toothpasteDevice: Anti-plaque

Comparator: High SLS Toothpaste

EXPERIMENTAL

Interventions

No SLS toothpasteDrug

Toothpaste no Sodium Lauryl Sulfate

Also known as: Sensodyne ProNamel Fresh Breath Toothpaste

Comparator: No SLS Toothpaste

Medium SLS toothpasteDrug

Less than or equal to X ppm Sodium Lauryl Sulfate

Also known as: Clinpro Tooth Creme

Eligibility Criteria

Age18 Years - 90 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (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;

Sponsors & Collaborators

Solventum US LLC
Industrylead
3M
Industrycollaborator

Study Sites (1)

3M Health Care

Saint Paul, Minnesota, 55144, United States

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

Study Officials

Brenda C Coalwell, BA
3M Health Care Business Group
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: Yes

Enrollment

53 participants (actual enrollment reported by the registry).

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

Study Record Dates

First Submitted

October 13, 2020

First Posted

October 23, 2020

Study Start

Study Stopped

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Other Outcomes (1)

Study Arms (3)

Comparator: No SLS Toothpaste

Comparator: Medium SLS Toothpaste

Comparator: High SLS Toothpaste

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Limitations and Caveats

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Other Outcomes (1)

Study Arms (3)

Comparator: No SLS Toothpaste

Comparator: Medium SLS Toothpaste

Comparator: High SLS Toothpaste

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Limitations and Caveats

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations