CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 80 enrolled
Drug / intervention
SmartMouth Clinical DDS mouthrinse +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02709785
NCT02709785N/ACompleted

SmartMouth Advanced Clinical Formula Clinical Research Design Protocol

St. Louis University·interventional·Posted Mar 16, 2016·Updated Dec 4, 2018

In Brief

A clinical study evaluating SmartMouth Clinical DDS mouthrinse, 0.12% chlorhexidine rinse, and 1 other intervention for Gingivitis and Periodontitis. Completed, enrolled 80 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedMar 16, 2016
Enrollment StartMar 1, 2016
Primary CompletionMay 1, 2017
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 10.3 years ago

Interventions

SmartMouth Clinical DDS mouthrinsedrug

Subjects use SmartMouth Clinical DDS mouth rinse for six weeks.

0.12% chlorhexidine rinsedrug

Subjects use chlorhexidine mouth rinse for six weeks.

Placebo rinsedrug

Subjects use placebo mouth rinse for six weeks. The placebo rinse is the same as SmartMouth Clinical DDS, but without the active ingredients.