NCT02861664

Assessment of the Efficacy of an Experimental Occlusion Technology Dentifrice in Dentinal Hypersensitivity

A Study to Evaluate the Efficacy of an Experimental Occlusion Technology Dentifrice in the Relief of Dentinal Hypersensitivity

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 135 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This study will evaluate the effectiveness of an experimental dentifrice containing stannous fluoride, an established dentine tubule occlusion technology, at reducing dentine hypersensitivity (DH) compared to a negative control dentifrice. The test and control dentifrices will be administered for a total of 8 weeks, with assessments (via evaporative air and tactile stimuli) at baseline, and after 4 and 8 weeks twice-daily use.

Detailed description

This single centre, randomized, controlled, examiner-blind, 2 treatment arm, parallel group design study, stratified by maximum baseline Schiff sensitivity score (of the two selected teeth), with a treatment period of 8 weeks will investigate the clinical effectiveness of an experimental stannous fluoride dentifrice in the reduction of DH. DH will be assessed at Baseline, and after 4 and 8 weeks treatment to monitor clinical efficacy and safety.

Conditions

• Dentin Sensitivity

Interventions

Type	Name	Description
OTHER	Stannous fluoride (SnF2)	Dentifrice containing 0.454% weight by weight (w/w) SnF2 and 0.072% w/w NaF
OTHER	Sodium monofluorophosphate (SMFP)	Dentifrice containing 1400 ppm fluoride as SMFP

Timeline

• Start date: 2016-09-21
• Primary completion: 2016-12-01
• Completion: 2016-12-24
• First posted: 2016-08-10
• Last updated: 2018-08-10
• Results posted: 2018-08-10

Locations

1 site across 1 country: China