Efficacy of ClōSYS® Sensitive Fluoride Toothpaste and ClōSYS® Sensitive Rinse Regimen on MGI, PI … (NCT05258721) | Clinical Trial Compass
CompletedPhase 2
Efficacy of ClōSYS® Sensitive Fluoride Toothpaste and ClōSYS® Sensitive Rinse Regimen on MGI, PI and BOP
United States60 participantsStarted 2021-07-06
Plain-language summary
90-day, self-controlled, longitudinal, non-blinded clinical trial which will measure changes in clinical parameters in participants with gingivitis and Stage I or II periodontitis who apply ClōSYS® Sensitive Fluoride Toothpaste and ClōSYS® Sensitive Rinse.
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Subjects are between the ages of 18 to 80 years
* Subjects have a minimum of 20 permanent teeth, excluding third molars
* Subjects have been diagnosed with gingivitis or periodontitis (Stages I and II are based on the level of CAL and Bone Loss (BL). The diagnosis is Stage I if: (a) BL is less than 15% and (b) CAL is between 1-2mm. The diagnosis is Stage II if: (a) BL is between 15% and 33% and (b) CAL is between 3-4mm)
* Subjects exhibit bleeding upon probing in \>20% of sites
* Subject is seen every 3 months for routine dental prophylaxis/periodontal maintenance
* Subjects do not have a significant medical history or metabolic diseases (diabetes with A1C ≥ 7.0, pregnancy)
* Subject is currently a non-smoker or has discontinued smoking at least 6 months prior to enrollment
* Subject agrees to refrain from use of the following products: Peridex®, PerioGuard®, Listerine®, Cepacol®, Crest Pro-Health® rinse, Colgate Total® rinse, Colgate Total® toothpaste, Crest Pro Health® toothpaste, or any generic equivalent while participating in this study. Alcohol is not the active ingredient in any oral rinse product and does not produce a significant antibacterial effect
* Subject is able to read and provide written informed consent
* Subject is able to follow verbal and/or written instructions, perform oral hygiene procedures and return to the test facility for specified study examinations
* Subject agrees not to receive a dental "cleaning" (prophylaxis) while in …