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

NCT05258721 | Completed Phase 2 Results FDA Drug

• 1 other identifier: ATSU-RPR-Oral rinse 2020
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Gingivitis; Periodontitis

Keywords

Gingivitis or periodontitis (Stage I or II)

Outcome Measures

Primary Outcomes (3)

• Changes in Modified Gingival Index (MGI)

  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)

  Baseline and 12 weeks

• Changes in Plaque Index (PI)

  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.

  Baseline and 12 weeks

• Changes in Bleeding On Probing (BOP)

  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.

  Baseline and 12 weeks

Secondary Outcomes (1)

• Adverse Events

  90 Days

Study Arms (1)

Treatment Group

EXPERIMENTAL

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.

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

Interventions

ClōSYS® Sensitive Fluoride Toothpaste DRUG

ClōSYS® Sensitive Fluoride Toothpaste is an over-the-counter drug product containing 0.12% stabilized chlorine dioxide (sodium chlorite in an aqueous solution) and 0.13% w/v fluoride ion.

Treatment Group

ClōSYS® Sensitive Rinse OTHER

ClōSYS® Sensitive Rinse is a cosmetic product containing 0.1% stabilized chlorine dioxide.

Treatment Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rowpar Pharmaceuticals, Inc.: lead

Study Sites (1)

Arizona School of Dentistry & Oral Health

Mesa, Arizona, 85206, United States

Location

MeSH Terms

Conditions

Gingivitis; Periodontitis

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Results Point of Contact

• Title: Jai Shewale
• Organization: Arcadia Consumer Healthcare, Inc.

jshewale@arcadiach.com

504-913-4344

Study Officials

• Jaiprakash Shewale, Ph.D.

  Rowpar Pharmaceuticals, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2022
• First Posted: February 28, 2022
• Study Start: July 6, 2021
• Primary Completion: October 31, 2022
• Study Completion: October 31, 2022
• Last Updated: August 15, 2025
• Results First Posted: March 15, 2023

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)