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

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

Study Overview

• Status: Completed
• Conditions: Mucosal Inflammation; Sloughing Skin
• Intervention / Treatment: Other: Treatment

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Birmingham, United Kingdom, B5 7EG
    • University of Birmingham

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Aggregate number of lesions	Total lesion count aggregated across all subjects	30 minutes
Aggregate number of lesions	Total lesion count aggregated across all subjects	4 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lesion severity	Subject level mucosal severity sloughing score	30 minutes
Lesion severity	Subject level mucosal severity sloughing score	4 days

Collaborators and Investigators

• Sponsor: Unilever R&D
• Collaborators: University of Birmingham
• Investigators: Principal Investigator: Iain Chapple, Professor, The University of Birmingham

Study record dates

Study Major Dates

• Study Start (Actual): September 19, 2016
• Primary Completion (Actual): November 21, 2016
• Study Completion (Actual): November 21, 2016

Study Registration Dates

• First Submitted: July 16, 2018
• First Submitted That Met QC Criteria: July 16, 2018
• First Posted (Actual): July 26, 2018

Study Record Updates

• Last Update Posted (Actual): July 26, 2018
• Last Update Submitted That Met QC Criteria: July 16, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Stomatognathic Diseases; Mouth Diseases; Inflammation; Mucositis
• Other Study ID Numbers: ORL-OSS-2545

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No