Efficacy of ClōSYS® Sensitive Fluoride Toothpaste and ClōSYS® Sensitive Rinse Regimen on MGI, PI and BOP

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rowpar Pharmaceuticals, Inc.
• Treatments: Fluorides

Criteria

Inclusion Criteria:

• Subjects are between the ages of 18 to 75 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 the study

• Subject must permanently reside in Arizona

Exclusion Criteria:

• Subject has significant medical history or poorly controlled/uncontrolled diabetes (as defined above)

• Subject is pregnant

• Subject has a medical condition that requires antibiotic premedication prior to dental treatment

• Subject has taken antibiotics within 1 month of study enrollment

• Subject who takes multiple medications and/or herbal and dietary supplements known to alter bleeding and exhibits/reports spontaneous gingival bleeding

• Subject takes medications that may interfere with study results (eg. antibiotics, steroids, immunosuppressants, high dose aspirin (325+ mg/day), chemotherapy and/or radiation therapy for cancer).

• Subject is a current smoker

• Subject has a history of non-surgical or surgical periodontal therapy within 6 months of study participation

• Subject has Stage III or IV periodontitis, Grade B or C

• Subject is currently taking or in the past 28 days has taken another investigational drug or participated in other investigational studies that may impact study outcomes

• Subject has not had a dental cleaning within six months prior to the start of the study