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

NCT03598881 | Completed

• 1 other identifier: ORL-OSS-2545
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Sloughing Skin; Mucosal Inflammation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Lesion severity

  30 minutes

• Lesion severity

  4 days

Study Arms (2)

Treatment

EXPERIMENTAL

Toothpaste containing 0.32%NaF and no sodium lauryl sulphate (SLS)

Other: Treatment

Comparator

ACTIVE COMPARATOR

Toothpaste containing 0.8% sodium monofluorophosphate (SMFP) and sodium lauryl sulphate (SLS)

Other: Treatment

Interventions

Treatment OTHER

Comparator; Treatment

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• Unilever R&D: lead
• University of Birmingham: collaborator

Study Sites (1)

University of Birmingham

Birmingham, B5 7EG, United Kingdom

Location

MeSH Terms

Conditions

Necrosis; Mucositis

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Iain Chapple, Professor

  The University of Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2018
• First Posted: July 26, 2018
• Study Start: September 19, 2016
• Primary Completion: November 21, 2016
• Study Completion: November 21, 2016
• Last Updated: July 26, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)