- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04601103
3M Oral Rinse Incidence and Patient Acceptance of Sloughing When Used With Sodium Lauryl Sulfate (SLS) Toothpastes
3M Oral Rinse Evaluation of Incidence and Patient Acceptance of Sloughing When Used With Sodium Lauryl Sulfate (SLS) Toothpastes
Study Overview
Status
Conditions
Intervention / Treatment
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
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Minnesota
-
Saint Paul, Minnesota, United States, 55144
- 3M Health Care
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Comparator: No SLS Toothpaste
3M Oral Rinse in combination with no SLS toothpaste (A)
|
Toothpaste no Sodium Lauryl Sulfate
Other Names:
Rinse prevents bacterial adherence to teeth
Other Names:
|
Experimental: Comparator: Medium SLS Toothpaste
3M Oral Rinse in combination with medium SLS toothpaste (B)
|
Rinse prevents bacterial adherence to teeth
Other Names:
Less than or equal to X ppm Sodium Lauryl Sulfate
Other Names:
|
Experimental: Comparator: High SLS Toothpaste
3M Oral Rinse in combination with high SLS toothpaste (C)
|
Rinse prevents bacterial adherence to teeth
Other Names:
More than or equal to X ppm Sodium Lauryl Sulfate
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Oral Mucosal Exfoliation (Oral Sloughing)
Time Frame: End of treatment (3 weeks)
|
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
Time Frame: Mid-Treatment (10 days)
|
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.
Time Frame: End of Treatment (3 weeks)
|
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)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Number of Participants Reporting Their Acceptance Levels of Side Effects
Time Frame: End of Treatment (3 weeks)
|
Subjects were questioned regarding how acceptable were your side effects.
Using the following responses of: Completely unacceptable, somewhat unacceptable, somewhat acceptable, completely acceptable, did not experience side effects
|
End of Treatment (3 weeks)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Brenda C Coalwell, BA, 3M Health Care Business Group
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- EM-11-050043
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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