To Compare the Effectiveness of Three Self-care Oral Hygiene Regimens

Status Completed

Clinical Trial Summary

The study is designed to evaluate the clinical changes in gingival health by measuring the reduction of gingival bleeding and inflammation over 4 weeks. Additionally, plaque removal will be evaluated after a single use (part 1) and over 4 weeks (part 2).

Clinical Trial Description

Data will be analyzed and reported as mean. The target population is approximately 105 healthy adult volunteers. there will be three groups with 35 subjects per group. Subjects will be randomized using a simple random sample. A computer-generated randomization schedule will be prepared by the study statistician. Based on the randomization schedule, subjects will be randomly assigned in a 1:1:1 ratio. With 35 subjects per group, the study will have 90% power to detect an average reduction in the percent of sites with BOP of 25%. The primary outcome will be the reduction in the percentage of sites with bleeding on probing (BOP) after 4 weeks. Reduction in the percentage of sites with BOP after 2 weeks (+/- 2 days). Reduction in the Modified Gingival index after 2 (+/- 2 days) and 4 weeks (+/- 2 days). Reduction in Rustogi Modification of Navy Plaque Index pre & Post, 2 weeks (+/- 2 days) and 4 weeks (+/- 2 days). Data will include whole mouth, approximal, marginal, facial, and lingual analysis for all indices. Intraoral examination will be performed and any adverse events will be reported and followed-up. Subjects will complete a questionnaure at the completion of the study. ;

Study Design

Related Conditions & MeSH terms

Gingivitis

Clinical Trial Details

NCT number	NCT04804670
Study type	Interventional
Source	Water Pik, Inc.
Contact
Status	Completed
Phase	N/A
Start date	October 19, 2020
Completion date	January 8, 2021

View Details

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