CompletedNot Applicable

Controlling Oral Malodor by ClōSYS Oral Rinse

99 participantsStarted 2016-11

Plain-language 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.

Who can participate

Age range21 Years – 65 Years

SexALL

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Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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.

What they're measuring

Reduction in Malodor as Measured by Organoleptic Score

Timeframe: Weekly for three weeks

Trial details

NCT IDNCT03160573

SponsorRowpar Pharmaceuticals, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-02

Results submitted2020-09-07

View on ClinicalTrials.gov More Oral Malodor trials