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

Periodontitis Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05258721
Study type Interventional
Source Rowpar Pharmaceuticals, Inc.
Contact
Status Completed
Phase Phase 2
Start date July 6, 2021
Completion date October 31, 2022
View Details
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