Controlling Oral Malodor by ClōSYS® Oral Rinse

Study Design:

The products used in the study are: ClōSYS Alcohol-Free Oral Rinse (also referred as ClōSYS Unflavored Oral Rinse) and ClōSYS justRIGHT MILD MINT Oral Rinse (also referred as ClōSYS Flavored Oral Rinse or Gentle Mint Flavored Oral Rinse). This is an in-vivo, eight-week, a single-center, randomized, double-blind (subject/investigator), 2-way cross-over design clinical study. There are two independent groups. Each subject of each group gets crossed over to the other sub-group within a same group after the washout period. Each group has their own control group. In the first phase, 25 subjects (50%) of each group are randomly assigned to the active group; the other 25 subjects are assigned to the control group. In the second phase, the participants will be crossed over within sub-group assignment. The Study enrolled 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.

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 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: Subjects in Test group will receive ClōSYS® Unflavored Rinse.
• ClōSYS® Flavored Rinse (Drug), also known as Mouth rinse: Subjects in Test group will receive ClōSYS® Flavored Rinse.
• Placebo (Other): Subjects in Placebo group will receive Placebo Rinse.

Primary outcomes

• Change in Malodor as Measured by Organoleptic Score [At baseline and weekly for 3 weeks for each condition and cross-over]: 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. Breath scores were compared to baseline with malodor intensity reduction recorded as negative.

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

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.

Participant flow

Outcome results

• Change in Malodor as Measured by Organoleptic Score (Primary), Mean, score on a scale: Unflavored Rinse, Then Placebo 3.09 +/- .34; Flavored Rinse, Then Placebo 3.08 +/- .38; Placebo Flavored, Then Flavored Rinse 3.03 +/- .19; Placebo Unflavored, Then Unflavored Rinse 3.23 +/- .41 (p <0.010)

Adverse events

Time frame: Eight weeks (the entire course of the study)

• Statistical Analysis Plan (PDF, 2016-03-01)

• Yiming Li, DDS MSD PhD, Principal investigator, Center for Dental Research, Loma Linda University School of Dentistry