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

NCT03421145 · Status: COMPLETED · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2024-10-01

Study results available
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Summary

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

Conditions

  • Plaque

Interventions

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.

Sponsors & Collaborators

  • 3M

    collaborator INDUSTRY

  • Solventum US LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-12-17
Primary Completion
2019-01-17
Completion
2019-01-17

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03421145 on ClinicalTrials.gov