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Controlling Oral Malodor by ClōSYS Oral Rinse

NCT03160573 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 99

Last updated 2020-12-22

Study results available
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Summary

The purpose of this Study is to assess the efficacy of two ClōSYS Oral Rinse products in human subjects in controlling oral malodor in partial fulfillment of the requirements for recognition by the American Dental Association's (ADA) requirement for obtaining ADA Seal for malodor.

Conditions

  • Oral Malodor

Interventions

DRUG

ClōSYS® Unflavored Rinse

DRUG

ClōSYS® Flavored Rinse

OTHER

Placebo-Flavored Oral Rinse

Flavor-matched placebo rinse

OTHER

Placebo-Unflavored Oral Rinse

Unflavored-matched placebo rinse

Sponsors & Collaborators

  • University Health Resources Group, Inc.

    collaborator OTHER

  • Rowpar Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Sushma Nachnani, Ph.D. · University Health Resources Group, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2017-02-28
Completion
2017-02-28

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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 NCT03160573 on ClinicalTrials.gov