Six Week Study of Experimental Mouth Rinses: Effect on Gingivitis and Plaque
Completed · Phase 1
Conditions studied: Gingivitis, Plaque
In brief
The purpose of this study is to evaluate the safety and efficacy of experimental mouth rinse formulations compared to a positive control mouth rinse and a hydroalcohol control mouth rinse for the reduction of gingivitis and plaque when used as an adjunct to tooth brushing during a six-week product usage period.
Key facts
- Study ID
- NCT04921371
- Run by
- Johnson & Johnson Consumer Inc. (J&JCI)
- People needed
- 157
- Starts
- 2019-10-08
- Expected to finish
- 2019-12-19
- Last updated by the study team
- 2023-09-28
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Adequate oral hygiene (That is brush teeth daily and exhibit no signs or oral neglect)
- A minimum of 20 gradable teeth including 4 molars with scorable facial and lingual surfaces. Teeth that are grossly carious, extensively restored, orthodontically banded, abutments, exhibiting severe generalized cervical and/or enamel abrasion, teeth with veneers, or third molars will not be included in the tooth count
- A mean gingival index greater than or equal to (>=) 1.95 per the Modified Gingival Index at Baseline (for those in the randomized treatment group)
- A mean gingival index less than or equals to (<=) 0.75 per the Modified Gingival Index at Baseline (for those in the healthy reference group)
- A mean plaque index >= 1.95 per the 6 site Turesky modification of the Quigley-Hein Plaque Index at Baseline (for those in randomized treatment groups)
- Greater than or equal to 10 percent (%) bleeding sites at baseline (for those in randomized treatment groups)
You may not qualify if…
- History of significant adverse effects, including sensitivities or suspected allergies, following use of oral hygiene products such as toothpastes, mouth rinses and red food dye
- Dental prophylaxis within four weeks prior to Screening/Baseline 1 visit
- More than three sites that have periodontal pockets depths measuring 5mm or greater in depth
- Teeth having periodontal pocket depths measuring more than 3 mm in depth (healthy reference group)
- History of medical conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures
- Use of Antibiotics, anti-inflammatory or anticoagulant therapy, phenytoin sodium or diphenylhydantoin, calcium channel blockers, cyclosporin A, immunostimulants/ immunomodulators during the study or within the one month prior to the Baseline 1 exam. Intermittent use of certain anti-inflammatory medication is acceptable at the discretion of the Investigator
Where it is running
- Salus Research, Inc. — Fort Wayne, Indiana, United States
Full record on ClinicalTrials.gov
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