drugset / Trial / NCT02709785

SmartMouth Advanced Clinical Formula Clinical Research Design Protocol

NCT02709785

RandomizedParallel-groupTriple-blindTreatment

Summary

The aim of this study is to provide evidence on the clinical efficacy of SmartMouth Advanced Clinical Formula mouthrinse in comparison to the efficacy of 0.12% chlorhexidine mouthrinse and a placebo mouthrinse. The placebo will be provided by the sponsor and will be identical to SmartMouth ACF (Advanced Clinical Formula), except it will not contain cetylpyridinium chloride, zinc chloride and sodium chlorite. The primary outcomes include measures of plaque and gingivitis. Secondary outcomes include evaluation of tooth discoloration, taste perception, malodor and calculus.

Timeline

Start
2016-03
Primary completion
2017-05
Completion
2017-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Chlorhexidine Small molecule 0.12 % Other
Subject SmartMouth Clinical DDS Unknown Other