NCT05258721

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

Efficacy of ClōSYS® Sensitive Fluoride Toothpaste and ClōSYS® Sensitive Rinse Regimen on Plaque, Gingival Inflammation and Bleeding Upon Probing

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Rowpar Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Gingivitis
• Periodontitis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-07-06
• Primary completion: 2022-10-31
• Completion: 2022-10-31
• First posted: 2022-02-28
• Last updated: 2025-08-15
• Results posted: 2023-03-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study