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A Study to Assess the Impact of a Non-SLS Toothpaste Upon Oral Mucosal Desquamation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03598881
Recruitment Status : Completed
First Posted : July 25, 2018
Last Update Posted : July 25, 2018
University of Birmingham
Information provided by (Responsible Party):
Unilever R&D

Brief Summary:
This study is to compare the effect on oral mucosal desquamation of a non-SLS toothpaste and an SLS-containing toothpaste..

Condition or disease Intervention/treatment Phase
Sloughing Skin Mucosal Inflammation Other: Treatment Not Applicable

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:

  1. Whole mouth data per subject: each non-zero severity score will be treated as one lesion count, giving a maximum score of 12;
  2. Subject level mucosal severity sloughing score: severity score averaged over the 12 areas assessed.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Other
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

Arm Intervention/treatment
Experimental: Treatment
Toothpaste containing 0.32%NaF and no sodium lauryl sulphate (SLS)
Other: Treatment
Active Comparator: Comparator
Toothpaste containing 0.8% sodium monofluorophosphate (SMFP) and sodium lauryl sulphate (SLS)
Other: Treatment

Primary Outcome Measures :
  1. Aggregate number of lesions [ Time Frame: 30 minutes ]
    Total lesion count aggregated across all subjects

  2. Aggregate number of lesions [ Time Frame: 4 days ]
    Total lesion count aggregated across all subjects

Secondary Outcome Measures :
  1. Lesion severity [ Time Frame: 30 minutes ]
    Subject level mucosal severity sloughing score

  2. Lesion severity [ Time Frame: 4 days ]
    Subject level mucosal severity sloughing score

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. Internal (University of Birmingham Dental School) panellists only
  2. Willing to sign an informed consent form and complete a medical history questionnaire.
  3. Must be available for the duration of the study.
  4. Must be a current non-smoker and not chew tobacco.
  5. 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:

  1. Show unwillingness, inability or lack of motivation to carry out the study procedures
  2. Are pregnant or breastfeeding females.
  3. Are diabetic.
  4. Have severe oral mucosal problems.
  5. Orthodontic banding or removable partial dentures
  6. Have an active cold sore.
  7. Have any oral piercings.
  8. Have a mouth ulcer or who experience mouth ulcers on a regular basis, Lichen Planus Vesiculo-Bullous disorders
  9. 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
  10. Volunteers who are at risk from transient bacteraemias.
  11. Regular use of medication, which could interfere with study objectives or affect the validity of the study.
  12. Have or have had a medical or dental condition, which in the option of the dentist would make them unsuitable for inclusion.
  13. Have problem of bleeding after brushing.
  14. Must not be a regular user of chlorhexidine mouthwash, or have used it within the past 6 weeks.
  15. Has allergic responses to dental/oral hygiene products or components in the formulation of the toothpaste.
  16. The subject is participating in other studies testing oral care products.
  17. The subject is an employee of Unilever.

Information from the National Library of Medicine

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 identifier (NCT number): NCT03598881

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United Kingdom
University of Birmingham
Birmingham, United Kingdom, B5 7EG
Sponsors and Collaborators
Unilever R&D
University of Birmingham
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Principal Investigator: Iain Chapple, Professor The University of Birmingham

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Responsible Party: Unilever R&D Identifier: NCT03598881     History of Changes
Other Study ID Numbers: ORL-OSS-2545
First Posted: July 25, 2018    Key Record Dates
Last Update Posted: July 25, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pathologic Processes
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases