Oral MalodorNCT03160573
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 recognition by the 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
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 99 participants
- Where
- No sites listed yet
- Study dates
- Nov 2016to Feb 2017
- 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
- Subject has read, signed, and received a copy of the Informed Consent prior to Study initiation.
- Subject is able to follow verbal and/or written instructions, perform oral hygiene procedures and return to the test facility for specified Study examinations.
- Subject is between the ages of 21 and 65 years of age, male or female.
- Subject has normal oral interior cheek wall tissues.
- 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.
- Subject must have an average organoleptic intensity rating of at least 2.6 but maximum 4.5 on an intensity scale of 0-5.
Who cannot join
- Pregnant or nursing per subject report.
- Diagnosis of Xerostomia, including medication induced Xerostomia.
- Any oral or extraoral piercing that interferes with the ability to perform study procedures and/or clinical assessments in the mouth.
- Fixed or removable oral appliance, such as orthodontic brackets or retainer, partial or complete dentures.
- Have advanced periodontal disease or excessive gingival recession, per Investigator/Examiner discretion.
- A known allergy or sensitivity to products planned for use in this study.
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- Unwillingness to abstain from all other oral hygiene products other than those prescribed for the duration of the study.
- Heavy deposits of calculus, either supragingival and/or subgingival, per Investigator/Examiner discretion.
- Have a history of severe transmittable infectious disease (hepatitis, HIV, tuberculosis).
- Have a medical or dental condition that would be unduly affected by participation in this study, per Investigator discretion.
- Any other condition that Principal Investigator would consider interfering with the study.
- Smokers.
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 recognition by the American Dental Association's (ADA) requirement for obtaining ADA Seal for malodor.
Read the detailed description
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.
- Conditions
- Oral Malodor
- Being tested
- ClōSYS® Unflavored Rinse, ClōSYS® Flavored Rinse, Placebo-Flavored Oral Rinse, Placebo-Unflavored Oral Rinse
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
ClōSYS® Flavored RinseDrug
Also called Mouth rinse
Placebo-Flavored Oral RinseOther
Flavor-matched placebo rinse
Placebo-Unflavored Oral RinseOther
Unflavored-matched placebo rinse
| Study group | Role | What they receive |
|---|---|---|
| Test-Unflavored Rinse then Placebo Unflavored Rinse | Active comparator | Participants will receive CloSYS unflavored rinse containing 0.1% stabilized chlorine dioxide (sodium chlorite) in an aqueous solution for 3 weeks,. After a washout period of 2 weeks, they will then receive Placebo unflavored rinse containing containing NO 0.1% stabilized chlorine dioxide for 3 weeks. Receives: Drug: ClōSYS® Unflavored Rinse |
| Test-Flavored Rinse then Placebo Flavored Rinse | Active comparator | Participants will receive CloSYS mint-flavored rinse containing 0.1% stabilized chlorine dioxide (sodium chlorite) in an aqueous solution for 3 weeks. After a washout period of 2 weeks, they will then receive Placebo flavored rinse containing NO 0.1% stabilized chlorine dioxide for 3 weeks. Receives: Drug: ClōSYS® Flavored Rinse |
| Flavored Oral Rinse-Placebo then Test-Flavored Rinse | Placebo comparator | Participants will receive CloSYS mint flavored rinse containing NO 0.1% stabilized chlorine dioxide for 3 weeks. After a washout period of 2 weeks, they will then receive CloSYS mint-flavored rinse containing 0.1% stabilized chlorine dioxide (sodium chlorite) in an aqueous solution for 3 weeks. Receives: Other: Placebo-Flavored Oral Rinse |
| Unflavored Oral Rinse-Placebo then Test-Unflavored Rinse | Placebo comparator | Participants will receive CloSYS unflavored rinse containing NO 0.1% stabilized chlorine dioxide for 3 weeks. After a washout period of 2 weeks, they will then receive unflavored rinse containing 0.1% stabilized chlorine dioxide (sodium chlorite) in an aqueous solution for 3 weeks. Receives: Other: Placebo-Unflavored Oral Rinse |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction 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.
Measured: Weekly for three weeks
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 startNov 2016
- Primary completionFeb 2017
- Study completionFeb 2017
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
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rowpar Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University Health Resources Group, Inc.
- Responsible party
- Sponsor
- Investigators
- Sushma Nachnani, Ph.D., Principal investigator, University Health Resources Group, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03160573
- Sponsor's protocol ID
- UHRG-RPR-Malodor-ADA-2016
- Status last verified
- Nov 2020
- First submitted
- 10 May 2017
- Last updated
- 22 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2020. 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
- NCT03160573
- Acronym / sponsor ID
- UHRG-RPR-Malodor-ADA-2016
- Conditions
- Oral Malodor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Rowpar Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Collaborators
- University Health Resources Group, Inc.
- Study start
- Nov 2016 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 19 May 2017 (actual)
- Results
- Posted 22 Dec 2020
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 recognition by the American Dental Association's (ADA) requirement for obtaining ADA Seal for malodor.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Test-Unflavored Rinse then Placebo Unflavored Rinse | Active comparator | Drug: ClōSYS® Unflavored RinseParticipants will receive CloSYS unflavored rinse containing 0.1% stabilized chlorine dioxide (sodium chlorite) in an aqueous solution for 3 weeks,. After a washout period of 2 weeks, they will then receive Placebo unflavored rinse containing containing NO 0.1% stabilized chlorine dioxide for 3 weeks. |
| Test-Flavored Rinse then Placebo Flavored Rinse | Active comparator | Drug: ClōSYS® Flavored RinseParticipants will receive CloSYS mint-flavored rinse containing 0.1% stabilized chlorine dioxide (sodium chlorite) in an aqueous solution for 3 weeks. After a washout period of 2 weeks, they will then receive Placebo flavored rinse containing NO 0.1% stabilized chlorine dioxide for 3 weeks. |
| Flavored Oral Rinse-Placebo then Test-Flavored Rinse | Placebo comparator | Other: Placebo-Flavored Oral RinseParticipants will receive CloSYS mint flavored rinse containing NO 0.1% stabilized chlorine dioxide for 3 weeks. After a washout period of 2 weeks, they will then receive CloSYS mint-flavored rinse containing 0.1% stabilized chlorine dioxide (sodium chlorite) in an aqueous solution for 3 weeks. |
| Unflavored Oral Rinse-Placebo then Test-Unflavored Rinse | Placebo comparator | Other: Placebo-Unflavored Oral RinseParticipants will receive CloSYS unflavored rinse containing NO 0.1% stabilized chlorine dioxide for 3 weeks. After a washout period of 2 weeks, they will then receive unflavored rinse containing 0.1% stabilized chlorine dioxide (sodium chlorite) in an aqueous solution for 3 weeks. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subject has read, signed, and received a copy of the Informed Consent prior to Study initiation.
- Subject is able to follow verbal and/or written instructions, perform oral hygiene procedures and return to the test facility for specified Study examinations.
- Subject is between the ages of 21 and 65 years of age, male or female.
- Subject has normal oral interior cheek wall tissues.
- 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.
Key exclusion criteria (12 listed)
- Pregnant or nursing per subject report.
- Diagnosis of Xerostomia, including medication induced Xerostomia.
- Any oral or extraoral piercing that interferes with the ability to perform study procedures and/or clinical assessments in the mouth.
- Fixed or removable oral appliance, such as orthodontic brackets or retainer, partial or complete dentures.
- Have advanced periodontal disease or excessive gingival recession, per Investigator/Examiner discretion.
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 rinse | Drug | Test-Unflavored Rinse then Placebo Unflavored Rinse |
| ClōSYS® Flavored RinseAlso: Mouth rinse | Drug | Test-Flavored Rinse then Placebo Flavored Rinse |
| Placebo-Flavored Oral RinseFlavor-matched placebo rinse | Other | Flavored Oral Rinse-Placebo then Test-Flavored Rinse |
| Placebo-Unflavored Oral RinseUnflavored-matched placebo rinse | Other | Unflavored Oral Rinse-Placebo then Test-Unflavored Rinse |
Primary outcome
Reduction in Malodor as Measured by Organoleptic Score
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Sushma Nachnani, Ph.D. principal investigator
University Health Resources Group, Inc.
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 6 inclusion and 12 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 22 Dec 2020. 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 22 Dec 2020). 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?
Reduction in Malodor as Measured by Organoleptic Score (time frame: Weekly for three weeks). 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 22 Dec 2020.