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Determination of the Safety and Efficacy of a Novel Oral Rinse on Oral Health

NCT04197427 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2019-12-17

No results posted yet for this study

Summary

Since over 50% of the US population have gingivitis, mouthrinses serve as a valuable adjunct to brushing and flossing. The primary objective is to determine the effectiveness of the oral rinse in reducing plaque and gingivitis and improve a patient's breath

Conditions

  • Plaque
  • Gingivitis

Interventions

DEVICE

Experimental Oral Rinse

Experimental Oral Rinse is a proprietary formulation of GRAS ingredients

DEVICE

Placebo

Placebo formulation without the active ingredients

Sponsors & Collaborators

  • You First Services

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-03-01
Primary Completion
2020-11-30
Completion
2020-12-31
FDA Device
Yes

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 NCT04197427 on ClinicalTrials.gov