Efficacy of ClōSYS Oral Rinse Products in Human Subjects in Controlling Oral Malodor

NCT03160573 NA COMPLETED Results posted

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.

Details

Lead sponsor	Rowpar Pharmaceuticals, Inc.
Phase	NA
Status	COMPLETED
Enrolment	99
Start date	2016-11
Completion	2017-02

Conditions

• Oral Malodor

Interventions

• ClōSYS® Unflavored Rinse
• ClōSYS® Flavored Rinse
• Placebo-Flavored Oral Rinse
• Placebo-Unflavored Oral Rinse

Primary outcomes

• Reduction in Malodor as Measured by Organoleptic Score — Weekly for three weeks
  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.