NCT02768194

Dentine Tubule Occlusion Assessment in a Modified in Situ Model

Assessment of Dentine Tubule Occlusion in a Modified in Situ Model

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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 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.

Conditions

• Dentin Sensitivity

Interventions

Type	Name	Description
DEVICE	Stannous fluoride	Dentifrice containing 0.454% stannous fluoride
OTHER	Sodium monofluorophosphate	Dentifrice containing 0.76% sodium monofluorophosphate
OTHER	Mineral water	Commercially available mineral water

Timeline

• Start date: 2016-07-06
• Primary completion: 2016-09-01
• Completion: 2016-09-21
• First posted: 2016-05-11
• Last updated: 2018-06-25
• Results posted: 2018-03-13

Locations

1 site across 1 country: United Kingdom