drugset / Trial / NCT02709785
SmartMouth Advanced Clinical Formula Clinical Research Design Protocol
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Chlorhexidine | Small molecule | 0.12 % | Other |
| Subject | SmartMouth Clinical DDS | Unknown | — | Other |