HalitosisPhase 1/2BCHSNCT00875927
Effects of Breezy Candy on Halitosis
A Phase 1/2 study testing no scraping microcapsules, scraping microcapsules containing inert TCP microcapsules and scraping microcapsules containing Propolis in people with Halitosis, run by Breezy Industries Ltd. at 1 site in Israel.
Trial summary
Users of Breezy candy will utilize the candy's abrasiveness to scrape tongue surface. The scraping action together with the release of compounds contained inside the abrasive microcapsules will result in significant reduction of oral halitosis. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Halitosis
- What is being tested?
- no scraping microcapsules, scraping microcapsules containing inert TCP microcapsules and scraping microcapsules containing Propolis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteIsrael
- Study dates
- May 2009to Jul 2009
- Phase
- Phase 1/2
- 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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- adult
- healthy
- male
- female
- bad breath
Who cannot join
- subject suffering from Diabetes
- subject suffering from renal disease
- pregnant women
- cigarette smokers
- any illness of oral cavity for the last 3 months
- subjects undergoing chemotherapy
- treatment by antibiotic
- treatment by anti-inflammatory
Trial locations and contacts
1 site in 1 country.
Israel1 site
Hillel Yaffe Medical Center
Hadera, 38100
Shlomi Ashtar, 972-4-6304930, shlomia@hy.health.gov.il
Shlomo Barak, MD
About this study
Official title: Breezy Candy Halitosis Study
Users of Breezy candy will utilize the candy's abrasiveness to scrape tongue surface. The scraping action together with the release of compounds contained inside the abrasive microcapsules will result in significant reduction of oral halitosis.
- Conditions
- Halitosis
- Being tested
- no scraping microcapsules, scraping microcapsules containing inert TCP microcapsules, scraping microcapsules containing Propolis, scraping microcapsules containing and Zinc, scraping microcapsules containing Propolis and Zinc
- Keywords
- Halitosis
- Medical subject headings
- Halitosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no scraping microcapsulesOther
1, 4 grams isomalt candy containing no scraping microcapsules
scraping microcapsules containing inert TCP microcapsulesOther
1, 4 grams isomalt candy containing 2% inert TCP scraping microcapsules
scraping microcapsules containing PropolisOther
1, 4 grams, isomalt candy containing 2% Propolis scraping microcapsules
scraping microcapsules containing and ZincOther
1, 4 grams, isomalt candy containing 2% Zinc scraping microcapsules
scraping microcapsules containing Propolis and ZincOther
1, 4 grams, isomalt candy containing 2% Propolis and Zinc scraping microcapsules
| Study group | Role | What they receive |
|---|---|---|
| 1 - control | Active comparator | candy not including scraping microcapsules Receives: Other: no scraping microcapsules |
| 2 - Scraping | Active comparator | candy including scraping TCP microcapsules Receives: Other: scraping microcapsules containing inert TCP microcapsules |
| 3 - Scraping plus Propolis | Active comparator | candy including scraping Propolis microcapsules Receives: Other: scraping microcapsules containing Propolis |
| 4 - Scraping plus Zinc | Active comparator | candy including scraping Zinc microcapsules Receives: Other: scraping microcapsules containing and Zinc |
| 5 - Scraping plus Propolis and Zinc | Active comparator | candy including scraping Propolis and Zinc microcapsules Receives: Other: scraping microcapsules containing Propolis and Zinc |
What is being measured
The primary outcome is the main question the study is designed to answer.
Users of Breezy Candy will have fresher breath over Control
Measured: 150 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2009 (estimated)
- Study startMay 2009
- Primary completionJun 2009 (estimated)
- Study completionJul 2009 (estimated)
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.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Breezy Industries Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Shlomo Barak, MD, Principal investigator, Mouth and Jaw institute, Hillel Yaffe Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00875927
- Sponsor's protocol ID
- BCHS
- Acronym
- BCHS
- Status last verified
- Apr 2009
- First submitted
- 10 Mar 2009
- Last updated
- 7 Apr 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breezy Candy Halitosis Study
- ClinicalTrials.gov ID
- NCT00875927
- Acronym / sponsor ID
- BCHS / BCHS
- Conditions
- Halitosis
- Keywords
- Halitosis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Breezy Industries Ltd.Industry (pharma, biotech, devices)
- Study start
- May 2009
- Primary completion
- Jun 2009 (estimated)
- Study completion
- Jul 2009 (estimated)
- First posted
- 6 Apr 2009 (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.
Users of Breezy candy will utilize the candy's abrasiveness to scrape tongue surface. The scraping action together with the release of compounds contained inside the abrasive microcapsules will result in significant reduction of oral halitosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1 - control | Active comparator | Other: no scraping microcapsulescandy not including scraping microcapsules |
| 2 - Scraping | Active comparator | Other: scraping microcapsules containing inert TCP microcapsulescandy including scraping TCP microcapsules |
| 3 - Scraping plus Propolis | Active comparator | Other: scraping microcapsules containing Propoliscandy including scraping Propolis microcapsules |
| 4 - Scraping plus Zinc | Active comparator | Other: scraping microcapsules containing and Zinccandy including scraping Zinc microcapsules |
| 5 - Scraping plus Propolis and Zinc | Active comparator | Other: scraping microcapsules containing Propolis and Zinccandy including scraping Propolis and Zinc microcapsules |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- adult
- healthy
- male
- female
- bad breath
Key exclusion criteria (8 listed)
- subject suffering from Diabetes
- subject suffering from renal disease
- pregnant women
- cigarette smokers
- any illness of oral cavity for the last 3 months
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 |
|---|---|---|
| no scraping microcapsules1, 4 grams isomalt candy containing no scraping microcapsules | Other | 1 - control |
| scraping microcapsules containing inert TCP microcapsules1, 4 grams isomalt candy containing 2% inert TCP scraping microcapsules | Other | 2 - Scraping |
| scraping microcapsules containing Propolis1, 4 grams, isomalt candy containing 2% Propolis scraping microcapsules | Other | 3 - Scraping plus Propolis |
| scraping microcapsules containing and Zinc1, 4 grams, isomalt candy containing 2% Zinc scraping microcapsules | Other | 4 - Scraping plus Zinc |
| scraping microcapsules containing Propolis and Zinc1, 4 grams, isomalt candy containing 2% Propolis and Zinc scraping microcapsules | Other | 5 - Scraping plus Propolis and Zinc |
Primary outcome
Users of Breezy Candy will have fresher breath over Control
Time frame: 150 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2009.
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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.
Shlomo Barak, MD principal investigator
Mouth and Jaw institute, Hillel Yaffe Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing no scraping microcapsules, scraping microcapsules containing inert TCP microcapsules and scraping microcapsules containing Propolis in people with Halitosis, run by Breezy Industries Ltd. at 1 site in Israel.
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 5 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 7 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maya Eshed, MSc, MBA (972-54-4498669, mayae@breezy.co.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Users of Breezy Candy will have fresher breath over Control (time frame: 150 minutes). 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 Apr 2009.