Controlling Oral Malodor by ClōSYS Oral Rinse

NCT03160573 | Completed Results DMC

• 1 other identifier: UHRG-RPR-Malodor-ADA-2016
• Study Type: interventional
• Target: 99
• 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 recognition by the American Dental Association's (ADA) requirement for obtaining ADA Seal for malodor.

Conditions

Oral Malodor

Outcome Measures

Primary Outcomes (1)

• Reduction 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.

  Weekly for three weeks

Study Arms (4)

Test-Unflavored Rinse then Placebo Unflavored Rinse

ACTIVE COMPARATOR

Participants will receive CloSYS unflavored rinse containing 0.1% stabilized chlorine dioxide (sodium chlorite) in an aqueous solution for 3 weeks,. After a washout period of 2 weeks, they will then receive Placebo unflavored rinse containing containing NO 0.1% stabilized chlorine dioxide for 3 weeks.

Drug: ClōSYS® Unflavored Rinse

Test-Flavored Rinse then Placebo Flavored Rinse

ACTIVE COMPARATOR

Participants will receive CloSYS mint-flavored rinse containing 0.1% stabilized chlorine dioxide (sodium chlorite) in an aqueous solution for 3 weeks. After a washout period of 2 weeks, they will then receive Placebo flavored rinse containing NO 0.1% stabilized chlorine dioxide for 3 weeks.

Drug: ClōSYS® Flavored Rinse

Flavored Oral Rinse-Placebo then Test-Flavored Rinse

PLACEBO COMPARATOR

Participants will receive CloSYS mint flavored rinse containing NO 0.1% stabilized chlorine dioxide for 3 weeks. After a washout period of 2 weeks, they will then receive CloSYS mint-flavored rinse containing 0.1% stabilized chlorine dioxide (sodium chlorite) in an aqueous solution for 3 weeks.

Other: Placebo-Flavored Oral Rinse

Unflavored Oral Rinse-Placebo then Test-Unflavored Rinse

PLACEBO COMPARATOR

Participants will receive CloSYS unflavored rinse containing NO 0.1% stabilized chlorine dioxide for 3 weeks. After a washout period of 2 weeks, they will then receive unflavored rinse containing 0.1% stabilized chlorine dioxide (sodium chlorite) in an aqueous solution for 3 weeks.

Other: Placebo-Unflavored Oral Rinse

Interventions

ClōSYS® Unflavored Rinse DRUG

Also known as: Mouth rinse

Test-Unflavored Rinse then Placebo Unflavored Rinse

ClōSYS® Flavored Rinse DRUG

Also known as: Mouth rinse

Test-Flavored Rinse then Placebo Flavored Rinse

Placebo-Flavored Oral Rinse OTHER

Flavor-matched placebo rinse

Flavored Oral Rinse-Placebo then Test-Flavored Rinse

Placebo-Unflavored Oral Rinse OTHER

Unflavored-matched placebo rinse

Unflavored Oral Rinse-Placebo then Test-Unflavored Rinse

Eligibility Criteria

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

You may qualify if:

• Subject has read, signed, and received a copy of the Informed Consent prior to Study initiation.
• Subject is able to follow verbal and/or written instructions, perform oral hygiene procedures and return to the test facility for specified Study examinations.
• Subject is between the ages of 21 and 65 years of age, male or female.
• Subject has normal oral interior cheek wall tissues.
• Subject is in good general health as determined by medical history and clinical judgment that no severe or debilitating disease exists that would impede participation in the Study.
• Subject must have an average organoleptic intensity rating of at least 2.6 but maximum 4.5 on an intensity scale of 0-5.

You may not qualify if:

• Pregnant or nursing per subject report.
• Diagnosis of Xerostomia, including medication induced Xerostomia.
• Any oral or extraoral piercing that interferes with the ability to perform study procedures and/or clinical assessments in the mouth.
• Fixed or removable oral appliance, such as orthodontic brackets or retainer, partial or complete dentures.
• Have advanced periodontal disease or excessive gingival recession, per Investigator/Examiner discretion.
• A known allergy or sensitivity to products planned for use in this study.
• Unwillingness to abstain from all other oral hygiene products other than those prescribed for the duration of the study.
• Heavy deposits of calculus, either supragingival and/or subgingival, per Investigator/Examiner discretion.
• Have a history of severe transmittable infectious disease (hepatitis, HIV, tuberculosis).
• Have a medical or dental condition that would be unduly affected by participation in this study, per Investigator discretion.
• Any other condition that Principal Investigator would consider interfering with the study.
• Smokers.

Sponsors & Collaborators

• Rowpar Pharmaceuticals, Inc.: lead
• University Health Resources Group, Inc.: 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: Sushma Nachnani, MS, PhD
• Organization: University Health Resources Group

sushnach@yahoo.com

(310) 645-8576

Study Officials

• Sushma Nachnani, Ph.D.

  University Health Resources Group, Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

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: November 1, 2016
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: December 22, 2020
• Results First Posted: December 22, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share