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

NCT05258721 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-08-15

Study results available
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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

Interventions

DRUG

ClōSYS® Sensitive Fluoride Toothpaste

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.

OTHER

ClōSYS® Sensitive Rinse

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

Sponsors & Collaborators

  • Rowpar Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Jaiprakash Shewale, Ph.D. · Rowpar Pharmaceuticals, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-06
Primary Completion
2022-10-31
Completion
2022-10-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05258721 on ClinicalTrials.gov