SmartMouth Advanced Clinical Formula Clinical Research Design Protocol

NCT02709785 NA COMPLETED Results posted

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.

Details

Lead sponsor	St. Louis University
Phase	NA
Status	COMPLETED
Enrolment	80
Start date	2016-03
Completion	2017-05

Conditions

• Gingivitis
• Periodontitis

Interventions

• SmartMouth Clinical DDS mouthrinse
• 0.12% chlorhexidine rinse
• Placebo rinse

Primary outcomes

• Gingival Index — 6 weeks
  Gingival Index scores gingival inflammation from 0 (healthy) to 3 (severe inflammation). The higher the score, the greater the gingival inflammation (worse outcome). Differences were assessed between treatment groups for changes in values from baseline to 6 weeks. If data were normally distributed, the paired t test was used to assess changes; otherwise the Wilcoxon signed rank test was used.

Countries

United States