A Study to Assess the Impact of a Non-SLS Toothpaste Upon Oral Mucosal Desquamation
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|ClinicalTrials.gov Identifier: NCT03598881|
Recruitment Status : Completed
First Posted : July 25, 2018
Last Update Posted : July 25, 2018
|Condition or disease||Intervention/treatment||Phase|
|Sloughing Skin Mucosal Inflammation||Other: Treatment||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||A Study to Assess the Impact of a Non-SLS Toothpaste Upon Oral Mucosal Desquamation|
|Actual Study Start Date :||September 19, 2016|
|Actual Primary Completion Date :||November 21, 2016|
|Actual Study Completion Date :||November 21, 2016|
Toothpaste containing 0.32%NaF and no sodium lauryl sulphate (SLS)
Active Comparator: Comparator
Toothpaste containing 0.8% sodium monofluorophosphate (SMFP) and sodium lauryl sulphate (SLS)
- Aggregate number of lesions [ Time Frame: 30 minutes ]Total lesion count aggregated across all subjects
- Aggregate number of lesions [ Time Frame: 4 days ]Total lesion count aggregated across all subjects
- Lesion severity [ Time Frame: 30 minutes ]Subject level mucosal severity sloughing score
- Lesion severity [ Time Frame: 4 days ]Subject level mucosal severity sloughing score
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03598881
|University of Birmingham|
|Birmingham, United Kingdom, B5 7EG|
|Principal Investigator:||Iain Chapple, Professor||The University of Birmingham|