CompletedNCT03160560Updated Jan 7, 2021Results posted

Controlling Oral Malodor by ClōSYS® Oral Rinse

An interventional study of ClōSYS® Unflavored Rinse and ClōSYS® Flavored Rinse in Oral Malodor, sponsored by Rowpar Pharmaceuticals, Inc.. Completed. Open to participants aged 21 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-01-07.

Sponsored by Rowpar Pharmaceuticals, Inc. · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 100
Allocation: Randomized
Ages: 21 Years to 65 Years
Sex: All

Study 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.

Read the detailed description

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.

Conditions studied

Oral Malodor

In context

Lead sponsor

Rowpar Pharmaceuticals, Inc. is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 21 Years to 65 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

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

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.

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover assignment
Masking: Double (Participant, Investigator)
Enrollment: 100 participants (actual)

Study arms

Active comparator
Test-Unflavored Rinse
CloSYS Oral Rinse product containing 0.1% stabilized chlorine dioxide (sodium chlorite) in aqueous solution.
Drug: ClōSYS® Unflavored Rinse
Active comparator
Test-Flavored Rinse
CloSYS Oral Rinse product containing 0.1% stabilized chlorine dioxide (sodium chlorite) in aqueous solution with mint flavoring.
Drug: ClōSYS® Flavored Rinse
Placebo comparator
Placebo
CloSYS Oral Rinse product (no chlorine dioxide)
Other: Placebo

Interventions

DrugClōSYS® Unflavored Rinse
Subjects in Test group will receive ClōSYS® Unflavored Rinse.
Also known as: Mouth rinse
DrugClōSYS® Flavored Rinse
Subjects in Test group will receive ClōSYS® Flavored Rinse.
Also known as: Mouth rinse
OtherPlacebo
Subjects in Placebo group will receive Placebo Rinse.

What researchers measure

Primary outcomes

Change in Malodor as Measured by Organoleptic Score
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.
Time frame: At baseline and weekly for 3 weeks for each condition and cross-over

Results

Posted Jan 7, 2021

Participant flow

Study panelists were recruited by placing IRB-approved advertisements in the the Loma Linda University newsletter and local communities. Potential subjects were interviewed by telephone and screened for their eligibility to participate in the study.

First Intervention (3 Weeks)

Participant flow — First Intervention (3 Weeks)
Milestone	Test-Unflavored Rinse, Then Placebo	Test-Flavored Rinse, Then Placebo	Placebo, Then Flavored Rinse	Placebo, Then Unflavored Rinse
Started	25	25	25	25
Completed	23	24	24	25
Not completed	2	1	1	0
Withdrew: Withdrawal by subject	2	1	1	0

Washout (2 Weeks)

Participant flow — Washout (2 Weeks)
Milestone	Test-Unflavored Rinse, Then Placebo	Test-Flavored Rinse, Then Placebo	Placebo, Then Flavored Rinse	Placebo, Then Unflavored Rinse
Started	23	24	24	25
Completed	23	24	24	25
Not completed	0	0	0	0

Second Intervention (3 Weeks)

Participant flow — Second Intervention (3 Weeks)
Milestone	Test-Unflavored Rinse, Then Placebo	Test-Flavored Rinse, Then Placebo	Placebo, Then Flavored Rinse	Placebo, Then Unflavored Rinse
Started	23	24	24	25
Completed	22	24	24	25
Not completed	1	0	0	0
Withdrew: Withdrawal by subject	1	0	0	0

Outcome measures

PrimaryChange in Malodor as Measured by Organoleptic Score

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.

Time frame:: At baseline and weekly for 3 weeks for each condition and cross-over
Reported as:: Mean · score on a scale

Change in Malodor as Measured by Organoleptic Score
score on a scale	Unflavored Rinse, Then Placebo	Flavored Rinse, Then Placebo	Placebo Flavored, Then Flavored Rinse	Placebo Unflavored, Then Unflavored Rinse
Baseline	3.09 ± .34	3.08 ± .38	3.03 ± .19	3.23 ± .41
Week 1	2.90 ± .52	2.92 ± .31	3.11 ± .46	3.19 ± .50
Week 2	2.64 ± .48	2.78 ± .40	3.07 ± .53	3.12 ± .43
Week 3	2.58 ± .43	2.68 ± .51	3.07 ± .44	3.19 ± .43
Baseline 2-Crossover	3.44 ± .50	3.20 ± .44	3.15 ± .42	3.14 ± .46
Week 6	3.18 ± .61	3.04 ± .49	3.17 ± .46	3.0 ± .41
Week 7	3.01 ± .59	2.94 ± .48	3.13 ± .40	3.10 ± .5
Week 8	2.96 ± .49	2.83 ± .44	3.10 ± .40	3.09 ± .43

Statistical analysis

Flavored Rinse, Then Placebo · Wilcoxon (Mann-Whitney) · p = <0.010
Placebo Flavored, Then Flavored Rinse · Wilcoxon (Mann-Whitney) · p = .932
Placebo Flavored, Then Flavored Rinse · Wilcoxon (Mann-Whitney) · p = .853
Flavored Rinse, Then Placebo · Wilcoxon (Mann-Whitney) · p = .032
Unflavored Rinse, Then Placebo · Wilcoxon (Mann-Whitney) · p = <0.001
Placebo Unflavored, Then Unflavored Rinse · Wilcoxon (Mann-Whitney) · p = .750
Placebo Unflavored, Then Unflavored Rinse · Wilcoxon (Mann-Whitney) · p = .810
Unflavored Rinse, Then Placebo · Wilcoxon (Mann-Whitney) · p = .006

Adverse events

Collected over Eight weeks (the entire course of the study). Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Test-Unflavored Rinse	0/50 (0%)	0/50 (0%)	0/50 (0%)
Test-Flavored Rinse	0/50 (0%)	0/50 (0%)	0/50 (0%)
Placebo Flavored Rinse	0/50 (0%)	0/50 (0%)	0/50 (0%)
Placebo Unflavored Rinse	0/50 (0%)	0/50 (0%)	0/50 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Test-Unflavored Rinse, Then Placebo	Test-Flavored Rinse, Then Placebo	Placebo, Then Flavored Rinse	Placebo, Then Unflavored Rinse	Total
<=18 years	0	0	0	0	0
Between 18 and 65 years	25	25	25	25	100
>=65 years	0	0	0	0	0

Age, Continuous
Age, Continuous(years)	Test-Unflavored Rinse, Then Placebo	Test-Flavored Rinse, Then Placebo	Placebo, Then Flavored Rinse	Placebo, Then Unflavored Rinse	Total
Mean	45.6 ± 13.5	40.6 ± 13.3	38.2 ± 13.3	45.7 ± 13.9	42.5 ± 13.5

Sex: Female, Male
Sex: Female, Male(Participants)	Test-Unflavored Rinse, Then Placebo	Test-Flavored Rinse, Then Placebo	Placebo, Then Flavored Rinse	Placebo, Then Unflavored Rinse	Total
Female	10	18	16	8	52
Male	13	6	8	17	44

Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)	Test-Unflavored Rinse, Then Placebo	Test-Flavored Rinse, Then Placebo	Placebo, Then Flavored Rinse	Placebo, Then Unflavored Rinse	Total
Count of participants	—	—	—	—	0

Region of Enrollment
Region of Enrollment(participants)	Test-Unflavored Rinse, Then Placebo	Test-Flavored Rinse, Then Placebo	Placebo, Then Flavored Rinse	Placebo, Then Unflavored Rinse	Total
United States	25	25	25	25	100

Study locations

No study locations are listed for this record.

References and documents

Study documents

Statistical analysis plan · Mar 1, 2016

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — Results are available upon request

Supporting information: Study protocol, Sap, Icf, Csr, Analytic code

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jan 7, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03160560
Lead sponsor: Rowpar Pharmaceuticals, Inc.
Collaborators: Loma Linda University
Responsible party: Sponsor
First posted: May 19, 2017
Start date: Aug 2016
Primary completion: Nov 2016
Completion: Nov 2016
Results posted: Jan 7, 2021
Last update: Jan 7, 2021

Study contacts

Yiming Li, DDS MSD PhD

principal investigator · Center for Dental Research, Loma Linda University School of Dentistry

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.

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