Dentine Tubule Occlusion Assessment in a Modified in Situ Model

March 19, 2018 updated by: GlaxoSmithKline

Assessment of Dentine Tubule Occlusion in a Modified in Situ Model

This will be a single centre, single blind, randomized, three treatment, three period crossover design, modified, in situ, study in healthy participants. In this in situ model the tubule occlusion properties of dentifrices will be evaluated by comparing an experimental dentifrice formulation to a regular fluoride dentifrice and a negative control (mineral water) over a ten day period.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This modified in situ model study will evaluate the mode-of-action of an experimental dentifrice containing stannous fluoride to occlude tubules compared to a regular fluoride dentifrice and a negative control (mineral water). The study treatments will be administered for a total of 10 days, with participants wearing two appliances in their mouth that will hold samples of dentine. The dentine samples will be examined after 1, 4, 8 and 10 days of treatment using scanning electron microscopy (SEM) and the resulting images graded for the amount of occlusion. In addition, the robustness of any occlusion generated by the treatments will be tested by exposing the dentine samples to an acid challenge (orange juice) after 9 and 10 days treatment.

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Bristol, United Kingdom, BS1 2LY
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Demonstrates understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
  • Aged between 18 and 80 years
  • Understands and is willing, able and likely to comply with all study procedures and restrictions.
  • Good general and mental health with, in the opinion of the investigator or medically qualified designee: No clinically significant and relevant abnormalities in medical history or upon oral examination, absence of any condition that would impact on the participant's safety or well being or affect the individual's ability to understand and follow procedures and requirements.
  • Be able to accommodate the lower bi-lateral buccal intra-oral appliances each fitted with four dentine samples

Exclusion Criteria:

  • Women who are known to be pregnant or who are intending to become pregnant over the duration of the study.
  • Women who are breast-feeding
  • Current or recurrent disease/dental pathology that in the opinion of the investigator could affect the study outcomes.

Current susceptibility to acid regurgitation, any orthodontic appliances, restorations, bridgework or dentures that in the opinion of the investigator would interfere with the study outcomes, recurrent or regular aphthous ulcers, severe gingivitis, carious lesions and periodontal disease,signs of severe dental erosion, any condition or medication which in the opinion of the investigator is currently causing xerostomia, and individuals who require antibiotic prophylaxis for dental procedures

  • Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients
  • Participation in another study (clinical or cosmetic studies) or receipt of an investigational drug within 15 days of the screening visit, previous participation in this study.
  • Recent history (within the last year) of alcohol or other substance abuse
  • An employee of the sponsor or the study site or members of their immediate family. The site for this protocol is the Clinical Trials Unit in the Bristol Dental School and Hospital. Employees of the Bristol Dental School and Hospital not associated with the Clinical Trials Unit are eligible to participate
  • Any participant who, in the judgement of the investigator, should not participate in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Test Product (0.454% stannous fluoride)
Participants will use dentifrice containing 0.454% stannous fluoride. Appliances brushed ex situ in 1:3 slurry of freshly prepared dentifrice twice daily will be then returned to the participant's mouth. Each appliance will be brushed for 1 minute (2 minutes total for both of the participant's appliances) using an electric toothbrush in a 1:3 slurry of assigned dentifrice. Appliances will be returned to the participant's mouth and the participant will rinse with 10 mls of mineral water for 5 seconds.
Device: Stannous fluoride
Dentifrice containing 0.454% stannous fluoride
Active Comparator: Reference Product (0.76% sodium monofluorophosphate)
Participants will use dentifrice containing 0.76% sodium monofluorophosphate. Appliances brushed ex situ in 1:3 slurry of freshly prepared dentifrice twice daily will be then returned to the participant's mouth. Each appliance will be brushed for 1 minute (2 minutes total for both of the participant's appliances) using an electric toothbrush in a 1:3 slurry of assigned dentifrice. Appliances will be returned to the participant's mouth and the participant will rinse with 10 mls of mineral water for 5 seconds.
Other: Sodium monofluorophosphate
Dentifrice containing 0.76% sodium monofluorophosphate
Other: Negative Control (Mineral water)
Participants will use commercially available mineral water. Appliances brushed ex situ in mineral water twice daily will be then returned to the participant's mouth. Each appliance will be brushed for 1 minute (2 minutes total for both of the participant's appliances) using an electric toothbrush in mineral water. Appliances will be returned to the participant's mouth and the participant will rinse with 10 mls of mineral water for 5 seconds.
Other: Mineral water
Commercially available mineral water

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Mean Occlusion Scores After 8 Days Treatment Application
Time Frame: Baseline and Day 8
Change from baseline (pre-dose) in the mean occlusion classification score was calculated. The degree of occlusion was measured using the following classification grades; 0 Not Evaluable, 1 Occluded, 2 Mostly Occluded, 3 Equally Occluded/Unoccluded, 4 Mostly Unoccluded and 5 Unoccluded
Baseline and Day 8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Mean Occlusion Scores After 1, 4, & 10 Days Treatment Application
Time Frame: Baseline, Day 1, 4, and 10
Change from baseline (pre-dose) in the mean occlusion classification score was calculated. The degree of occlusion was measured using the following classification grades; 0 Not Evaluable, 1 Occluded, 2 Mostly Occluded, 3 Equally Occluded/Unoccluded, 4 Mostly Unoccluded and 5 Unoccluded
Baseline, Day 1, 4, and 10

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 6, 2016

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

September 21, 2016

Study Registration Dates

First Submitted

May 9, 2016

First Submitted That Met QC Criteria

May 9, 2016

First Posted (Estimate)

May 11, 2016

Study Record Updates

Last Update Posted (Actual)

June 25, 2018

Last Update Submitted That Met QC Criteria

March 19, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 205699

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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