NCT02731833

Short Term Clinical Study Investigating the Efficacy of an Occluding Dentifrice in Providing Relief From Dentinal Hypersensitivity

A Clinical Study Investigating the Efficacy of an Occluding Dentifrice in Providing Relief From Dentinal Hypersensitivity

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 229 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This single centre, comparative design study will be used to investigate the efficacy of an experimental stannous fluoride containing dentifrice in relieving dentinal hypersensitivity (DH) after short term use compared with a standard fluoride dentifrice

Detailed description

This will be a single centre, three day, randomised, examiner blind, two treatment arm, parallel design, stratified (by maximum baseline Schiff sensitivity score of the two selected test teeth), controlled study, in participants with at least two sensitive teeth that meet all the criteria at the screening and baseline (pre-treatment) visits. Dentinal hypersensitivity will be assessed at baseline (pre-treatment), post-treatment and after 3 days twice daily brushing

Conditions

• Dentin Sensitivity

Interventions

Type	Name	Description
OTHER	stannous fluoride	0.454% weight by weight (w/w) stannous fluoride containing 1100ppm fluoride
OTHER	sodium monofluorophosphate	0.76% w/w sodium monofluorophosphate containing 1000ppm fluoride

Timeline

• Start date: 2016-04-01
• Primary completion: 2016-05-01
• Completion: 2016-05-20
• First posted: 2016-04-08
• Last updated: 2017-05-17
• Results posted: 2017-03-15

Locations

1 site across 1 country: Canada