NCT03421145

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

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

• Status: Completed
• Phase: —
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Solventum US LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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

Detailed 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.

Conditions

• Plaque

Interventions

Type	Name	Description
DEVICE	3M™ Oral Rinse	The Investigational Rinse contains a sugar-based surfactant using a proprietary formula. The intended use of the product is to help prevent and reduce plaque accumulation on the teeth and related gum-tissue inflammation (gingivitis).
OTHER	Vehicle Control Oral Rinse	The Placebo Comparator oral rinse is similar to the Experimental Oral Rinse only it does not contain the active ingredient.
DEVICE	PerioShield™ Oral Health Rinse	PerioShield™ Oral Health Rinse (0.2% delmopinol hydrochloride) is marketed in the US and was purchased for use in this study.
OTHER	Water	Purified bottled water containing no active ingredients.

Timeline

• Start date: 2017-12-17
• Primary completion: 2019-01-17
• Completion: 2019-01-17
• First posted: 2018-02-05
• Last updated: 2024-10-01
• Results posted: 2023-09-28

Locations

1 site across 1 country: United States