HalitosisNCT02665780
Assessing the Effect of Periodontal Debridement, Tongue Cleaning and Mouth Rinsing for the Treatment of Oral Malodour
A study testing Periodontal debridement and Cetylpyridium chloride in people with Halitosis, run by University of British Columbia.
Trial summary
This study evaluates the short and long term effect of dental cleaning and mouthrinsing for the treatment of bad breath Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Halitosis
- What is being tested?
- Periodontal debridement and Cetylpyridium chloride
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2017to 10 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Organoleptic score of 2 or more, and volatile sulfur compound score of greater than 1.5ng/10ml of hydrogen sulfide and 0.5ng/10ml of methyl mercaptan
- -
Who cannot join
- Moderate to severe periodontal disease, systemic illness or dental disease associated with halitosis, antibiotic use in the past month, need for antibiotic prophylaxis for dental procedures and current smokers
About this study
This study evaluates the short and long term effect of dental cleaning and mouthrinsing for the treatment of bad breath
Read the detailed description
The majority of bad breath producing bacteria can be found in pockets around the gums and the top of the tongue. It is generally agreed that one of the most effective means of controlling the production of bad breath gases from these bacteria is their mechanical removal. Tongue cleaning has shown consistent results in the reduction of bad breath, while dental cleaning has shown positive, but less conclusive results. The addition of a mouth rinse to mechanical measures has shown medium-term effectiveness, however there is currently no information available that describes the long-term impact of mechanical and chemical measures for the treatment of bad breath and the appropriate interval for follow-up and on-going management to prevent difficult cases.
- Conditions
- Halitosis
- Being tested
- Periodontal debridement, Cetylpyridium chloride
- Keywords
- halitosis, periodontal debridement, chemotherapeutics
- Medical subject headings
- Halitosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Periodontal debridementProcedure or surgery
teeth cleaning
Cetylpyridium chlorideOther
mouthrinse
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Periodontal debridement, tongue cleaning, mouth rinsing with 20ml Cetylpyridium Chloride daily for 24 weeks Receives: Procedure: Periodontal debridement; Other: Cetylpyridium chloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of oral malodour below threshold
Measured: 1, 12, 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2016 (estimated)
- Study startOct 2017 (estimated)
- Primary completion10 Oct 2018
- Study completion10 Oct 2018
Why it stopped: funding was not secured
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HalitosisStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leeann Donnelly, University of British Columbia
- Investigators
- Leeann Donnelly, PhD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02665780
- Sponsor's protocol ID
- H15-02159
- Status last verified
- Oct 2018
- First submitted
- 25 Jan 2016
- Last updated
- 15 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Effect of Periodontal Debridement, Tongue Cleaning and Mouth Rinsing for the Treatment of Oral Malodour
- ClinicalTrials.gov ID
- NCT02665780
- Acronym / sponsor ID
- H15-02159
- Conditions
- Halitosis
- Keywords
- halitosis, periodontal debridement, chemotherapeutics
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: funding was not secured
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Oct 2017 (estimated)
- Primary completion
- 10 Oct 2018 (actual)
- Study completion
- 10 Oct 2018 (actual)
- First posted
- 28 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the short and long term effect of dental cleaning and mouthrinsing for the treatment of bad breath
Detailed description
The majority of bad breath producing bacteria can be found in pockets around the gums and the top of the tongue. It is generally agreed that one of the most effective means of controlling the production of bad breath gases from these bacteria is their mechanical removal. Tongue cleaning has shown consistent results in the reduction of bad breath, while dental cleaning has shown positive, but less conclusive results. The addition of a mouth rinse to mechanical measures has shown medium-term effectiveness, however there is currently no information available that describes the long-term impact of mechanical and chemical measures for the treatment of bad breath and the appropriate interval for follow-up and on-going management to prevent difficult cases.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Procedure: Periodontal debridement, Other: Cetylpyridium chloridePeriodontal debridement, tongue cleaning, mouth rinsing with 20ml Cetylpyridium Chloride daily for 24 weeks |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Organoleptic score of 2 or more, and volatile sulfur compound score of greater than 1.5ng/10ml of hydrogen sulfide and 0.5ng/10ml of methyl mercaptan
- -
Key exclusion criteria (1 listed)
- Moderate to severe periodontal disease, systemic illness or dental disease associated with halitosis, antibiotic use in the past month, need for antibiotic prophylaxis for dental procedures and current smokers
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 |
|---|---|---|
| Periodontal debridementteeth cleaning | Procedure or surgery | Treatment |
| Cetylpyridium chloridemouthrinse | Other | Treatment |
Primary outcome
Reduction of oral malodour below threshold
Time frame: 1, 12, 24 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2018.
- 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.
Leeann Donnelly, PhD principal investigator
University of British Columbia
Questions about this trial
What is this clinical trial studying?
A study testing Periodontal debridement and Cetylpyridium chloride in people with Halitosis, run by University of British Columbia.
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 2 inclusion and 1 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: withdrawn, as of the sponsor's last update on 15 Oct 2018. 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. 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?
The study was withdrawn before enrolling participants, so there are no results.
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 of oral malodour below threshold (time frame: 1, 12, 24 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 15 Oct 2018.