Phase 2
N=60
Efficacy of ClōSYS® Sensitive Fluoride Toothpaste and ClōSYS® Sensitive Rinse Regimen on MGI, PI and BOP
Gingivitis · Periodontitis
Bottom Line
View on ClinicalTrials.gov: NCT05258721 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Mar 2023
Primary outcome: Primary: Changes in Modified Gingival Index (MGI) — 8.5; 1.5 score on a scale — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- ClōSYS® Sensitive Fluoride Toothpaste (Drug); ClōSYS® Sensitive Rinse (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Rowpar Pharmaceuticals, Inc.
- Primary completion
- Oct 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes in Modified Gingival Index (MGI) |
8.5; 1.5 | <0.001 sig |
| PRIMARY Changes in Plaque Index (PI) |
22.0; 8.0 | <0.001 sig |
| PRIMARY Changes in Bleeding On Probing (BOP) |
37.0; 15.0 | <0.001 sig |
| SECONDARY Adverse Events |
— | — |
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.
Eligibility Criteria
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 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
Data sourced from ClinicalTrials.gov (NCT05258721). 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.