N/A
N=80
SmartMouth Advanced Clinical Formula Clinical Research Design Protocol
Gingivitis · Periodontitis
Bottom Line
View on ClinicalTrials.gov: NCT02709785 ↗Enrolled (actual)
80
Serious AEs
0.0%
Results posted
Dec 2018
Primary outcome: Primary: Gingival Index — -0.22; -0.34; -0.19 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- SmartMouth Clinical DDS mouthrinse (Drug); 0.12% chlorhexidine rinse (Drug); Placebo rinse (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- St. Louis University
- Primary completion
- May 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Gingival Index |
-0.22; -0.34; -0.19 | — |
| SECONDARY Calculus Index |
-3.00; -5.00; -3.00 | — |
| SECONDARY Tooth Stain Index |
0; 3.5; 0 | — |
| SECONDARY Plaque Index |
-0.36; -0.62; -0.22 | — |
| SECONDARY Bleeding Score |
-0.39; -0.52; -0.43 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Subjects between the ages of 18 to 80
- Subjects with a diagnosis of gingivitis or chronic periodontitis
- Entry levels of gingival inflammation and plaque accumulation will be present (mean Gingival Index ≥ 0.4 and Plaque Index ≥ 1.0)
- Subjects that are in good medical health at time of the study
- At least 20 permanent natural teeth
Exclusion Criteria
- Use of local or systemic antibiotics during the course of the study
- Subjects that are pregnant or nursing mothers
- Subjects undergoing orthodontic therapy
- Subjects wearing removable prostheses
- Subjects taking medication which is altering the gingiva or causing inflammation
- Gingival overgrowth
- History of sensitivity or suspected allergies following the use of oral hygiene products
- Subjects taking anti-inflammatory or anticoagulant medications that would alter the gingiva and promote bleeding
- Subjects that require antibiotic prophylaxis prior to dental treatment
- Subjects that have acute dental problems requiring immediate treatment
Data sourced from ClinicalTrials.gov (NCT02709785). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.