drugset / Trial / NCT01827670

Investigating the Efficacy of a Dentifrice in Providing Long Term Relief From Dentinal Hypersensitivity

NCT01827670 ↗

Phase 3 Completed 119 enrolled GlaxoSmithKline
RandomizedParallel-groupSingle-blindTreatment

Summary

Clinical studies have demonstrated long term relief from dentine hypersensitivity with twice daily brushing of a toothpaste containing stannous fluoride in comparison to marketed (negative) controls. The aim of this study is to evaluate the effectiveness of a stannous fluoride dentifrice in the treatment of dentinal hypersensitivity compared to a marketed (negative) control, over a period of 56 days (8 weeks) with twice daily brushing.

Timeline

Start
2013-02
Primary completion
2013-05
Completion
2013-05

Outcome

Met primary endpoint

registry p <0.0001; Adjusted Mean -1.29 (95% CI -1.53 to -1.06); ANCOVA NCT01827670 ↗

paper At 4 and 8 weeks, between treatment analyses found the test dentifrice to be significantly better than the negative control dentifrice in relieving dentin hypersensitivity PMID 26437498 ↗

Drugs

EvaluationDrugModalityDoseRoute
Comparator sodium monofluorophosphate Unknown 0.76 % Topical
Subject stannous fluoride Small molecule 0.454 % Topical

Indications