Controlling Oral Malodor by ClōSYS Oral Rinse

Study Design:

The products used in this study are: ClōSYS Alcohol-Free Oral Rinse (referred here as ClōSYS Unflavored Oral Rinse) and ClōSYS justRIGHT MILD MINT Oral Rinse (referred here as ClōSYS Flavored Oral Rinse). This is an in-vivo, eight-week, a single-center, randomized, double-blind (subject/investigator), 2-waycross-overdesign clinical study. There will be two independent groups. Each subject of each group will be crossed over to the other group within a same group after the washout period. Each group will have their own control group. In the first phase, 25 subjects (50%) of each group will randomly be assigned to the active group; the other 25 subjects will be assigned to the control group. In the second phase, the participants will be crossed over of group assignment. The Study will enroll 100 subjects, aged 21 to 65 years, with a slight to strong intrinsic oral malodor, as determined by a panel of trained odor judges calibrated and standardized using a range of standard odorants sufficient to reflect the different patterns of nose receptors.

Study Plan:

Subjects will receive verbal and written oral hygiene instructions, and either one bottle (16 oz. each) of ClōSYS Unflavored Oral Rinse, ClōSYS Flavored Oral Rinse- or Placebo Oral Rinse each week. Subjects will also receive measuring cups for dispensing the rinse and a diary log for recording usage (the Oral Hygiene Kit) for use during the treatment. After a 2-week wash out period, each subject will receive another bottle of oral rinse according to their group assignment. The rinse bottles will be weighed prior to dispensing the product. A product log will be maintained and the weights of the bottles will be documented at each visit.

Subjects will be instructed to rinse twice a day, each in the morning and in the evening, with 15 mL mouth rinse for 30 seconds. They will note in their patient's log the date and time of rinsing.

Subjects will be instructed to continue with their normal oral hygiene practices, including tooth brushing and flossing but omitting any use of oral rinses or mouthwashes except for the Study materials. The subjects also will be instructed not to use other non-study related products such as breath mints, lozenge, gums, etc. as well as refraining from elective dental procedures during the study period.

• ClōSYS® Unflavored Rinse (Drug), also known as Mouth rinse
• ClōSYS® Flavored Rinse (Drug), also known as Mouth rinse
• Placebo-Flavored Oral Rinse (Other): Flavor-matched placebo rinse
• Placebo-Unflavored Oral Rinse (Other): Unflavored-matched placebo 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.

Sex: All, ages: 21 Years to 65 Years, accepts healthy volunteers

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.

Participant flow

Outcome results

• Reduction in Malodor as Measured by Organoleptic Score (Primary), Mean, score on a scale: Test-Unflavored Rinse Then Placebo Unflavored Rinse 3.58 +/- 0.67; Test-Flavored Rinse Then Placebo Flavored Rinse 3.60 +/- 0.63; Flavored Oral Rinse-Placebo Then Test Flavored Oral Rinse 3.63 +/- 0.62; Unflavored Oral Rinse-Placebo Then Test Unflavored Oral Rinse 3.65 +/- 0.66 (p <0.00001)

Adverse events

Time frame: 3 weeks for each intervention, 2 weeks for washout

• Study Protocol and Statistical Analysis Plan (PDF, 2017-03-01)

• Sushma Nachnani, Ph.D., Principal investigator, University Health Resources Group, Inc.