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A Clinical Study to Evaluate Effects of an Oral Rinse on Plaque and Gingivitis

Plaque Clinical Trial

Official title:
A Prospective, Randomized, Blinded, Clinical Study to Evaluate Effects of an Oral Rinse on Plaque and Gingivitis

Clinical Trial Summary

Rinse contains an anti-plaque agent that helps prevent the accumulation of dental plaque associated with gingivitis.

Clinical Trial Description

This is a prospective, single site, randomized, parallel, blinded clinical trial. Subjects will be randomly assigned to one of four treatment groups identified as Product A, Product B, Product C or Product D. Subjects will be screened for eligibility and entered into a washout period that is at least 7 days, during which time they will be provided with study toothbrush, toothpaste and dental floss. No oral rinses or medication that alters oral tissue health will be used or taken during the washout period. After randomization, the designated rinse will be placed into a non-transparent container so that other subjects and clinical examiners do not see the allocated rinse per the randomization schedule. Examinations for the clinical endpoints (PI, GI and BI) will be conducted at the baseline, 3-month, and 6-month visits. Interim visits will be scheduled to review diary, replenish study supplies, check study compliance, etc. Subjects will be provided Colgate Regular toothpaste, dental floss and a soft toothbrush (replaced at 3 months) for use during the 6-month study period. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03421145
Study type Interventional
Source 3M
Contact
Status Completed
Phase
Start date December 17, 2017
Completion date January 17, 2019
View Details
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