Controlling Oral Malodor by ClōSYS® Oral Rinse

NCT03160560 | Completed Results DMC

• 1 other identifier: LLUSD-RPR-Malodor-ADA-2016
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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 American Dental Association's (ADA) requirement for obtaining ADA Seal for malodor.

Conditions

Oral Malodor

Outcome Measures

Primary Outcomes (1)

• Change in Malodor as Measured by Organoleptic Score

  A 6-level organoleptic score from 0 - 5 will be used. Score of 0 indicating malodor cannot be detected and score of 5 indicating very strong malodor. Breath scores were compared to baseline with malodor intensity reduction recorded as negative.

  At baseline and weekly for 3 weeks for each condition and cross-over

Study Arms (3)

Test-Unflavored Rinse

ACTIVE COMPARATOR

CloSYS Oral Rinse product containing 0.1% stabilized chlorine dioxide (sodium chlorite) in aqueous solution.

Drug: ClōSYS® Unflavored Rinse

Test-Flavored Rinse

ACTIVE COMPARATOR

CloSYS Oral Rinse product containing 0.1% stabilized chlorine dioxide (sodium chlorite) in aqueous solution with mint flavoring.

Drug: ClōSYS® Flavored Rinse

Placebo

PLACEBO COMPARATOR

CloSYS Oral Rinse product (no chlorine dioxide)

Other: Placebo

Interventions

ClōSYS® Unflavored Rinse DRUG

Subjects in Test group will receive ClōSYS® Unflavored Rinse.

Also known as: Mouth rinse

Test-Unflavored Rinse

ClōSYS® Flavored Rinse DRUG

Subjects in Test group will receive ClōSYS® Flavored Rinse.

Also known as: Mouth rinse

Test-Flavored Rinse

Placebo OTHER

Subjects in Placebo group will receive Placebo Rinse.

Placebo

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Completion of the Informed Consent.
• Must be able to follow verbal/written instructions.
• Between 21 to 65 years of age, male or female.
• Has normal oral interior cheek wall tissues.
• In good general health.
• Should not have any severe or debilitating disease that may impede participation.
• Average organoleptic intensity rating of at \>2.6 but \<4.5 on an intensity scale of 0-5.

You may not qualify if:

• Pregnant or nursing.
• Diagnosis of Xerostomia, including medication induced Xerostomia.
• Oral or extraoral piercing that interferes with the clinical assessments in the mouth.
• Fixed or removable oral appliance.
• Advanced periodontal disease or excessive gingival recession.
• Known allergy or sensitivity to study products.
• Unwilling to abstain from all oral hygiene products other than those prescribed for the study.
• Heavy deposits of calculus, either supragingival and/or subgingival.
• History of severe transmittable infectious disease e.g. hepatitis, HIV, tuberculosis.
• Medical or dental condition that would be unduly affected by participation in this study.
• Any other condition that may interfere with the study.

Sponsors & Collaborators

• Rowpar Pharmaceuticals, Inc.: lead
• Loma Linda University: collaborator

MeSH Terms

Interventions

Mouthwashes

Intervention Hierarchy (Ancestors)

Biomedical and Dental Materials; Specialty Uses of Chemicals; Chemical Actions and Uses; Cosmetics; Manufactured Materials; Technology, Industry, and Agriculture

Results Point of Contact

• Title: Yiming Li, DDS, MSD, PhD, Professor and Associate Dean for Research
• Organization: Center for Dental Research, Loma Linda University

909-558-8069

Study Officials

• Yiming Li, DDS MSD PhD

  Center for Dental Research, Loma Linda University School of Dentistry

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2017
• First Posted: May 19, 2017
• Study Start: August 1, 2016
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: January 7, 2021
• Results First Posted: January 7, 2021

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: unlimited
• Access Criteria: Request