Controlling Oral Malodor by ClōSYS® Oral Rinse

• Status: Completed
• Trial end date: 2016-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Rowpar Pharmaceuticals, Inc.
• Collaborator: Loma Linda University

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.