Back to resultsA Study to Assess the Impact of a Non-SLS Toothpaste Upon Oral Mucosal Desquamation
Primary Purpose
Sloughing Skin, Mucosal Inflammation
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Treatment
Sponsored by
About this trial
This is an interventional other trial for Sloughing Skin
Eligibility Criteria
Inclusion Criteria:
- Internal (University of Birmingham Dental School) panellists only
- Willing to sign an informed consent form and complete a medical history questionnaire.
- Must be available for the duration of the study.
- Must be a current non-smoker and not chew tobacco.
- Have a minimum of 8 teeth in both upper and lower jaws, which are free from obvious untreated caries or significant periodontal disease
Exclusion Criteria:
- Show unwillingness, inability or lack of motivation to carry out the study procedures
- Are pregnant or breastfeeding females.
- Are diabetic.
- Have severe oral mucosal problems.
- Orthodontic banding or removable partial dentures
- Have an active cold sore.
- Have any oral piercings.
- Have a mouth ulcer or who experience mouth ulcers on a regular basis, Lichen Planus Vesiculo-Bullous disorders
- Obvious signs of untreated caries or significant periodontal disease, which in the opinion of the Study Dentist, will effect either the scientific validity of the study or if the volunteer's participation would affect their well being
- Volunteers who are at risk from transient bacteraemias.
- Regular use of medication, which could interfere with study objectives or affect the validity of the study.
- Have or have had a medical or dental condition, which in the option of the dentist would make them unsuitable for inclusion.
- Have problem of bleeding after brushing.
- Must not be a regular user of chlorhexidine mouthwash, or have used it within the past 6 weeks.
- Has allergic responses to dental/oral hygiene products or components in the formulation of the toothpaste.
- The subject is participating in other studies testing oral care products.
- The subject is an employee of Unilever.
Sites / Locations
- University of Birmingham
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Treatment
Comparator
Arm Description
Toothpaste containing 0.32%NaF and no sodium lauryl sulphate (SLS)
Toothpaste containing 0.8% sodium monofluorophosphate (SMFP) and sodium lauryl sulphate (SLS)
Outcomes
Primary Outcome Measures
Aggregate number of lesions
Total lesion count aggregated across all subjects
Aggregate number of lesions
Total lesion count aggregated across all subjects
Secondary Outcome Measures
Lesion severity
Subject level mucosal severity sloughing score
Lesion severity
Subject level mucosal severity sloughing score
Full Information
NCT ID
NCT03598881
First Posted
July 16, 2018
Last Updated
July 16, 2018
Sponsor
Unilever R&D
Collaborators
University of Birmingham
1. Study Identification
Unique Protocol Identification Number
NCT03598881
Brief Title
A Study to Assess the Impact of a Non-SLS Toothpaste Upon Oral Mucosal Desquamation
Official Title
A Study to Assess the Impact of a Non-SLS Toothpaste Upon Oral Mucosal Desquamation
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
September 19, 2016 (Actual)
Primary Completion Date
November 21, 2016 (Actual)
Study Completion Date
November 21, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Unilever R&D
Collaborators
University of Birmingham
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is to compare the effect on oral mucosal desquamation of a non-SLS toothpaste and an SLS-containing toothpaste..
Detailed Description
Subjects will use a wash out toothpaste for at least 10 days prior to each leg of the crossover design. Clinical assessment of oral mucosa status will be performed by a trained examiner before supervised product application, 30 minutes after product application and again after 4 days of twice daily brushing with product. Supervised product application consists of cap splint application of allocated toothpaste to maxillary arch followed by brushing whole mouth with toothpaste and swishing with resultant slurry around the mouth.
For visual sloughing evaluation, the oral mucosa will be divided into 12 assessment areas and each area evaluated for severity of sloughing on a 0 to 5 scale.
The following outcomes will be generated from the sloughing data:
Whole mouth data per subject: each non-zero severity score will be treated as one lesion count, giving a maximum score of 12;
Subject level mucosal severity sloughing score: severity score averaged over the 12 areas assessed.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sloughing Skin, Mucosal Inflammation
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
Toothpaste containing 0.32%NaF and no sodium lauryl sulphate (SLS)
Arm Title
Comparator
Arm Type
Active Comparator
Arm Description
Toothpaste containing 0.8% sodium monofluorophosphate (SMFP) and sodium lauryl sulphate (SLS)
Intervention Type
Other
Intervention Name(s)
Treatment
Primary Outcome Measure Information:
Title
Aggregate number of lesions
Description
Total lesion count aggregated across all subjects
Time Frame
30 minutes
Title
Aggregate number of lesions
Description
Total lesion count aggregated across all subjects
Time Frame
4 days
Secondary Outcome Measure Information:
Title
Lesion severity
Description
Subject level mucosal severity sloughing score
Time Frame
30 minutes
Title
Lesion severity
Description
Subject level mucosal severity sloughing score
Time Frame
4 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Internal (University of Birmingham Dental School) panellists only
Willing to sign an informed consent form and complete a medical history questionnaire.
Must be available for the duration of the study.
Must be a current non-smoker and not chew tobacco.
Have a minimum of 8 teeth in both upper and lower jaws, which are free from obvious untreated caries or significant periodontal disease
Exclusion Criteria:
Show unwillingness, inability or lack of motivation to carry out the study procedures
Are pregnant or breastfeeding females.
Are diabetic.
Have severe oral mucosal problems.
Orthodontic banding or removable partial dentures
Have an active cold sore.
Have any oral piercings.
Have a mouth ulcer or who experience mouth ulcers on a regular basis, Lichen Planus Vesiculo-Bullous disorders
Obvious signs of untreated caries or significant periodontal disease, which in the opinion of the Study Dentist, will effect either the scientific validity of the study or if the volunteer's participation would affect their well being
Volunteers who are at risk from transient bacteraemias.
Regular use of medication, which could interfere with study objectives or affect the validity of the study.
Have or have had a medical or dental condition, which in the option of the dentist would make them unsuitable for inclusion.
Have problem of bleeding after brushing.
Must not be a regular user of chlorhexidine mouthwash, or have used it within the past 6 weeks.
Has allergic responses to dental/oral hygiene products or components in the formulation of the toothpaste.
The subject is participating in other studies testing oral care products.
The subject is an employee of Unilever.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Iain Chapple, Professor
Organizational Affiliation
The University of Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Birmingham
City
Birmingham
ZIP/Postal Code
B5 7EG
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study to Assess the Impact of a Non-SLS Toothpaste Upon Oral Mucosal Desquamation
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