NCT03238352

A Study to Assess Efficacy of an Experimental Oral Rinse in Providing Long Term Relief From Dentinal Hypersensitivity

A Method Development Clinical Study Investigating the Efficacy of an Experimental Oral Rinse in Providing Long Term Relief From Dentinal Hypersensitivity

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 89 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

To investigate the efficacy of an experimental oral rinse, containing 1.5% potassium oxalate (KOX) and 0 parts per million (ppm) fluoride in relieving dentine hypersensitivity (DH) after 8 weeks use compared with a placebo oral rinse and a commercialized fluoride oral rinse.

Detailed description

This will be a single centre, eight week, randomized, examiner-blind, three treatment, parallel group, stratified study. It will be conducted in healthy participants, with at least two sensitive teeth that meet all of the study criteria at the Screening and Baseline visits. DH will be assessed at Baseline, and after 4 and 8 weeks twice daily treatment.

Conditions

• Dentin Sensitivity

Interventions

Type	Name	Description
DEVICE	Potassium oxalate	Oral rinse containing 1.5 percent (%) KOX and 0 ppm fluoride
DRUG	Sodium fluoride	Oral rinse containing 0.02% weight by weight (w/w) sodium fluoride (NaF)
OTHER	Placebo	Oral rinse containing 0% KOX and 0 ppm fluoride

Timeline

• Start date: 2017-08-07
• Primary completion: 2017-10-27
• Completion: 2017-10-27
• First posted: 2017-08-03
• Last updated: 2018-11-14
• Results posted: 2018-11-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study