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NCT02709785 · ClinicalTrials.gov registry record · NA

SmartMouth Advanced Clinical Formula Clinical Research Design Protocol

A NA study, sponsored by St. Louis University.

Completed
Registry status
NA
Development phase
80
Enrollment target

NCT02709785: Completed NA study, sponsored by St. Louis University.

NCT02709785 is a NA study that has completed, run by St. Louis University. The registered enrollment target is 80 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02709785, a NA study, has completed, sponsored by St. Louis University.

COMPLETED
Registry status
NA
Development phase
80 participants
Enrollment target

Study 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.

Primary Outcome

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.

Interventions

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

Trial Details

FieldValue
Enrollment Target 80 participants
Start Date 2016-03
Est. Completion 2017-05
Phase NA
St. Louis University

107 total trials

What the finished NCT02709785 record still lists

NCT02709785 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower).

The record links to 0 conditions, and to 3 interventions - of which SmartMouth Clinical DDS mouthrinse is the first listed.

NCT02709785 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02709785 about?

NCT02709785 is a clinical study titled "SmartMouth Advanced Clinical Formula Clinical Research Design Protocol". 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 (Adva...

What is the current status of trial NCT02709785?

This trial is currently completed. It is a NA study. The enrollment target is 80 participants. The study started on 2016-03. Estimated completion is 2017-05.

What interventions are being tested in trial NCT02709785?

The interventions under investigation include: SmartMouth Clinical DDS mouthrinse (DRUG), 0.12% chlorhexidine rinse (DRUG), Placebo rinse (DRUG).

Who is sponsoring clinical trial NCT02709785?

This trial is sponsored by St. Louis University, which has 107 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02709785's enrollment target sits among peer trials

80 994th of 2000 higher than 941 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02709785, the US trial registry maintained by the National Library of Medicine. NCT02709785 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.