Clinical Trial: Dentine Tubule Occlusion Assessment in a Modified in Situ Model

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Assessment of Dentine Tubule Occlusion in a Modified in Situ Model

Brief Summary: 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.

Detailed Summary: 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.
Sponsor: GlaxoSmithKline

Current Primary Outcome: Change from baseline in mean occlusion scores after 8 days treatment application [ Time Frame: Baseline to Day 8 ]

To measure the degree of occlusion using the following classification grades; 0 Not Evaluable, 1 Occluded, 2 Mostly Occluded, 3 Equally Occluded/Unoccluded, 4 Mostly Unoccluded and 5 Unoccluded


Original Primary Outcome: Same as current

Current Secondary Outcome: Change from baseline in mean occlusion scores after 1, 4, & 10 days treatment application [ Time Frame: Baseline, Day 1, Day 4, Day 10 ]

To measure the degree of occlusion using the following classification grades; 0 Not Evaluable, 1 Occluded, 2 Mostly Occluded, 3 Equally Occluded/Unoccluded, 4 Mostly Unoccluded and 5 Unoccluded


Original Secondary Outcome: Same as current

Information By: GlaxoSmithKline

Dates:
Date Received: May 9, 2016
Date Started: July 2016
Date Completion:
Last Updated: March 3, 2017
Last Verified: March 2017