Controlling Oral Malodor by ClōSYS Oral Rinse

• Status: Completed
• Trial end date: 2017-02-01
• 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 recognition by the 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.
• Collaborators: University Health Resources Group; University Health Resources Group, Inc.

Criteria

Inclusion Criteria:

1. Subject has read, signed, and received a copy of the Informed Consent prior to Study initiation.

2. Subject is able to follow verbal and/or written instructions, perform oral hygiene procedures and return to the test facility for specified Study examinations.

3. Subject is between the ages of 21 and 65 years of age, male or female.

4. Subject has normal oral interior cheek wall tissues.

5. 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.

6. Subject must have an average organoleptic intensity rating of at least 2.6 but maximum 4.5 on an intensity scale of 0-5.

Exclusion Criteria:

1. Pregnant or nursing per subject report.

2. Diagnosis of Xerostomia, including medication induced Xerostomia.

3. Any oral or extraoral piercing that interferes with the ability to perform study procedures and/or clinical assessments in the mouth.

4. Fixed or removable oral appliance, such as orthodontic brackets or retainer, partial or complete dentures.

5. Have advanced periodontal disease or excessive gingival recession, per Investigator/Examiner discretion.

6. A known allergy or sensitivity to products planned for use in this study.

7. Unwillingness to abstain from all other oral hygiene products other than those prescribed for the duration of the study.

8. Heavy deposits of calculus, either supragingival and/or subgingival, per Investigator/Examiner discretion.

9. Have a history of severe transmittable infectious disease (hepatitis, HIV, tuberculosis).

10. Have a medical or dental condition that would be unduly affected by participation in this study, per Investigator discretion.

11. Any other condition that Principal Investigator would consider interfering with the study.

12. Smokers.