A Three Month Bleeding-Model Clinical Study
Gingivitis
About this trial
This is an interventional treatment trial for Gingivitis
Eligibility Criteria
Inclusion Criteria: Be at least 18 years of age; Provide written informed consent prior to participation and be given a signed copy of the informed consent form; Be in general good health as determined by the Investigator based on a review of the health history/update for participation in the trial; Have at least 20 gradable teeth; Have established gingivitis with 10-70% bleeding sites; Agree to return for scheduled visits and follow the study procedures; Agree to refrain from use of any non-study oral hygiene products for the duration of the study; Agree to delay any elective dentistry, including dental prophylaxis, until the completion of the study. Exclusion Criteria: Having taken medications (antibiotic, anti-inflammatory, or anti-coagulant) which could alter gingival bleeding within 4 weeks of the Baseline Visit; Having any oral conditions that could interfere with study compliance and/or examination procedures, such as widespread caries, soft or hard tissue tumor of the oral cavity, or advanced periodontal disease; Having known hypersensitivity to the test products; Having removable oral appliances; Having fixed facial or lingual orthodontic appliances; Self-reported pregnancy or lactation; Having any diseases or condition that might interfere with the safe participation in the study; Having an inability to undergo study procedures.
Sites / Locations
- Silverstone Research Group
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Sham Comparator
Experimental
Positive Control
Negative Control
Experimental Control
2 brushings per day (AM and PM)
2 brushings per day (AM and PM)
Brush with Positive control in the morning and negative control in the evening