N/A
N=100
Controlling Oral Malodor by ClōSYS® Oral Rinse
Oral Malodor
Bottom Line
View on ClinicalTrials.gov: NCT03160560 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Jan 2021
Primary outcome: Primary: Change in Malodor as Measured by Organoleptic Score — 3.09; 3.08; 3.03; 3.23 score on a scale — p=<0.010
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- ClōSYS® Unflavored Rinse (Drug); ClōSYS® Flavored Rinse (Drug); Placebo (Other)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Rowpar Pharmaceuticals, Inc.
- Primary completion
- Nov 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Malodor as Measured by Organoleptic Score |
3.09; 3.08; 3.03; 3.23; 2.90; 2.92 | <0.010 sig |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT03160560). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.