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SmartMouth Advanced Clinical Formula Clinical Research Design Protocol

NCT02709785 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2018-12-04

Study results available
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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.

Conditions

  • Gingivitis
  • Periodontitis

Interventions

DRUG

SmartMouth Clinical DDS mouthrinse

Subjects use SmartMouth Clinical DDS mouth rinse for six weeks.

DRUG

0.12% chlorhexidine rinse

Subjects use chlorhexidine mouth rinse for six weeks.

DRUG

Placebo rinse

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

Sponsors & Collaborators

  • Triumph Pharmaceuticals

    collaborator UNKNOWN

  • St. Louis University

    lead OTHER

Principal Investigators

  • David D Miley, DMD · St. Louis University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2017-05-31
Completion
2017-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02709785 on ClinicalTrials.gov