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

Phase 2

Completed

Conditions: Gingivitis
Periodontitis

Interventions: Drug: ClōSYS® Sensitive Fluoride Toothpaste
Other: ClōSYS® Sensitive Rinse

Registration Number: NCT05258721

Lead Sponsor: Rowpar Pharmaceuticals, Inc.

Brief 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.

Detailed Description: The study will be conducted with 60 medically healthy participants between ages 18 to 75 years with gingival or periodontitis (Stage I or II) who are receiving routine preventive care and/or periodontal maintenance.

Subjects will brush with ClōSYS® Sensitive Fluoride Toothpaste twice daily and rinse with ClōSYS® Sensitive Rinse twice daily after brushing.

The primary response variables will be the Subjects' scores on the Plaque Index (PI), Gingival Index (GI) and the number of sites with bleeding upon probing (BOP). Probing depths and clinical attachment level will be assessed at baseline and 3 months. Adverse events will also be assessed and documented at each visit. In addition, Subjects will keep a usage diary documenting their daily use of the toothpaste and oral rinse and any comments or observations regarding usage or adverse events.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 60

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment Group	ClōSYS® Sensitive Fluoride Toothpaste	Participants with gingivitis or periodontitis (Stage I or II) brush with ClōSYS® Sensitive Fluoride Toothpaste twice daily and rinse with ClōSYS® Sensitive Rinse twice daily after brushing.
Treatment Group	ClōSYS® Sensitive Rinse	Participants with gingivitis or periodontitis (Stage I or II) brush with ClōSYS® Sensitive Fluoride Toothpaste twice daily and rinse with ClōSYS® Sensitive Rinse twice daily after brushing.

Primary Outcome Measures

Name	Time	Method
Changes in Modified Gingival Index (MGI)	Baseline and 12 weeks	MGI uses a rating score between 0 and 4, with 0 indicating a tooth with healthy gums and 4 the most severe inflammation. MGI scores were determined by visual exam of the gingiva on 4 surfaces for each tooth present except for third molars, for a total of 28 teeth. The total number of teeth exhibiting inflammation affecting all portions of the gingival unit (Score ≥ 2) were noted at each visit. The total number of teeth affected was evaluated for each visit in the final analysis. At baseline: Score range is (0-64) At 12 weeks: Score range is (0-32)
Changes in Plaque Index (PI)	Baseline and 12 weeks	The PI was recorded on all teeth except for third molars. PI was recorded on 4 surfaces of each tooth. PI uses a rating score between 0 and 3, with 0 indicating no plaque in gingival area and 3 heavy accumulation of plaque. Total score is reported. At baseline: Score range is 9 -157. At 12 weeks: Score range is 1 -147.
Changes in Probing Depths (PD)	90 Days	PD at six sites per tooth for all teeth
Changes in Clinical Attachment Level (CAL)	90 Days	CAL will be measured from the CEJ to the base of the pocket at 6 sites per tooth
Changes in Bleeding On Probing (BOP)	Baseline and 12 weeks	Bleeding On Probing (BOP) will be recorded as a dichotomous variable (present/absent) during the periodontal examination. The percentage of sites that bleed will be calculated by dividing the number of sites with bleeding by the total number of sites.