Oral MalodorNCT03160560
Controlling Oral Malodor by ClōSYS® Oral Rinse
A study testing ClōSYS® Unflavored Rinse and ClōSYS® Flavored Rinse in people with Oral Malodor, run by Rowpar Pharmaceuticals, Inc..
Trial 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 more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Malodor
- What is being tested?
- ClōSYS® Unflavored Rinse and ClōSYS® Flavored Rinse
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Aug 2016to Nov 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
About this study
Official title: Efficacy of ClōSYS® Oral Rinse Products in Human Subjects in Controlling Oral Malodor
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
- Oral Malodor
- Being tested
- ClōSYS® Unflavored Rinse, ClōSYS® Flavored Rinse, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClōSYS® Unflavored RinseDrug
Also called Mouth rinse
Subjects in Test group will receive ClōSYS® Unflavored Rinse.
ClōSYS® Flavored RinseDrug
Also called Mouth rinse
Subjects in Test group will receive ClōSYS® Flavored Rinse.
PlaceboOther
Subjects in Placebo group will receive Placebo Rinse.
| Study group | Role | What they receive |
|---|---|---|
| Test-Unflavored Rinse | Active comparator | CloSYS Oral Rinse product containing 0.1% stabilized chlorine dioxide (sodium chlorite) in aqueous solution. Receives: Drug: ClōSYS® Unflavored Rinse |
| Test-Flavored Rinse | Active comparator | CloSYS Oral Rinse product containing 0.1% stabilized chlorine dioxide (sodium chlorite) in aqueous solution with mint flavoring. Receives: Drug: ClōSYS® Flavored Rinse |
| Placebo | Placebo comparator | CloSYS Oral Rinse product (no chlorine dioxide) Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline and weekly for 3 weeks for each condition and cross-over
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2017
- Study startAug 2016
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Oral MalodorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rowpar Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Loma Linda University
- Responsible party
- Sponsor
- Investigators
- Yiming Li, DDS MSD PhD, Principal investigator, Center for Dental Research, Loma Linda University School of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03160560
- Sponsor's protocol ID
- LLUSD-RPR-Malodor-ADA-2016
- Status last verified
- Dec 2020
- First submitted
- 10 May 2017
- Last updated
- 7 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Results are available upon request
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of ClōSYS® Oral Rinse Products in Human Subjects in Controlling Oral Malodor
- ClinicalTrials.gov ID
- NCT03160560
- Acronym / sponsor ID
- LLUSD-RPR-Malodor-ADA-2016
- Conditions
- Oral Malodor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Rowpar Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Loma Linda University
- Study start
- Aug 2016
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 19 May 2017 (actual)
- Results
- Posted 7 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Test-Unflavored Rinse | Active comparator | Drug: ClōSYS® Unflavored RinseCloSYS Oral Rinse product containing 0.1% stabilized chlorine dioxide (sodium chlorite) in aqueous solution. |
| Test-Flavored Rinse | Active comparator | Drug: ClōSYS® Flavored RinseCloSYS Oral Rinse product containing 0.1% stabilized chlorine dioxide (sodium chlorite) in aqueous solution with mint flavoring. |
| Placebo | Placebo comparator | Other: PlaceboCloSYS Oral Rinse product (no chlorine dioxide) |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ClōSYS® Unflavored RinseAlso: Mouth rinseSubjects in Test group will receive ClōSYS® Unflavored Rinse. | Drug | Test-Unflavored Rinse |
| ClōSYS® Flavored RinseAlso: Mouth rinseSubjects in Test group will receive ClōSYS® Flavored Rinse. | Drug | Test-Flavored Rinse |
| PlaceboSubjects in Placebo group will receive Placebo Rinse. | Other | Placebo |
Primary outcome
Change in Malodor as Measured by Organoleptic Score
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Results are available upon request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yiming Li, DDS MSD PhD principal investigator
Center for Dental Research, Loma Linda University School of Dentistry
Questions about this trial
What is this clinical trial studying?
A study testing ClōSYS® Unflavored Rinse and ClōSYS® Flavored Rinse in people with Oral Malodor, run by Rowpar Pharmaceuticals, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Malodor as Measured by Organoleptic Score (time frame: At baseline and weekly for 3 weeks for each condition and cross-over). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2021.