Back to resultsEffects of Breezy Candy on Halitosis (BCHS)
Primary Purpose
Halitosis
Status
Unknown status
Phase
Phase 1
Locations
Israel
Study Type
Interventional
Intervention
no scraping microcapsules
scraping microcapsules containing inert TCP microcapsules
scraping microcapsules containing Propolis
scraping microcapsules containing and Zinc
scraping microcapsules containing Propolis and Zinc
Sponsored by
About this trial
This is an interventional treatment trial for Halitosis focused on measuring Halitosis
Eligibility Criteria
Inclusion Criteria:
- adult
- healthy
- male
- female
- bad breath
Exclusion Criteria:
- 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
Sites / Locations
- Hillel Yaffe Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
1 - control
2 - Scraping
3 - Scraping plus Propolis
4 - Scraping plus Zinc
5 - Scraping plus Propolis and Zinc
Arm Description
candy not including scraping microcapsules
candy including scraping TCP microcapsules
candy including scraping Propolis microcapsules
candy including scraping Zinc microcapsules
candy including scraping Propolis and Zinc microcapsules
Outcomes
Primary Outcome Measures
Users of Breezy Candy will have fresher breath over Control
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00875927
Brief Title
Effects of Breezy Candy on Halitosis
Acronym
BCHS
Official Title
Breezy Candy Halitosis Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2009
Overall Recruitment Status
Unknown status
Study Start Date
May 2009 (undefined)
Primary Completion Date
June 2009 (Anticipated)
Study Completion Date
July 2009 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Breezy Industries Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Halitosis
Keywords
Halitosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
75 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1 - control
Arm Type
Active Comparator
Arm Description
candy not including scraping microcapsules
Arm Title
2 - Scraping
Arm Type
Active Comparator
Arm Description
candy including scraping TCP microcapsules
Arm Title
3 - Scraping plus Propolis
Arm Type
Active Comparator
Arm Description
candy including scraping Propolis microcapsules
Arm Title
4 - Scraping plus Zinc
Arm Type
Active Comparator
Arm Description
candy including scraping Zinc microcapsules
Arm Title
5 - Scraping plus Propolis and Zinc
Arm Type
Active Comparator
Arm Description
candy including scraping Propolis and Zinc microcapsules
Intervention Type
Other
Intervention Name(s)
no scraping microcapsules
Intervention Description
1, 4 grams isomalt candy containing no scraping microcapsules
Intervention Type
Other
Intervention Name(s)
scraping microcapsules containing inert TCP microcapsules
Intervention Description
1, 4 grams isomalt candy containing 2% inert TCP scraping microcapsules
Intervention Type
Other
Intervention Name(s)
scraping microcapsules containing Propolis
Intervention Description
1, 4 grams, isomalt candy containing 2% Propolis scraping microcapsules
Intervention Type
Other
Intervention Name(s)
scraping microcapsules containing and Zinc
Intervention Description
1, 4 grams, isomalt candy containing 2% Zinc scraping microcapsules
Intervention Type
Other
Intervention Name(s)
scraping microcapsules containing Propolis and Zinc
Intervention Description
1, 4 grams, isomalt candy containing 2% Propolis and Zinc scraping microcapsules
Primary Outcome Measure Information:
Title
Users of Breezy Candy will have fresher breath over Control
Time Frame
150 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
adult
healthy
male
female
bad breath
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maya Eshed, MSc, MBA
Phone
972-54-4498669
Email
mayae@breezy.co.il
First Name & Middle Initial & Last Name or Official Title & Degree
Yoram Rubin
Phone
972-4-8342155
Email
info@medicguide.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shlomo Barak, MD
Organizational Affiliation
Mouth and Jaw institute, Hillel Yaffe Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hillel Yaffe Medical Center
City
Hadera
ZIP/Postal Code
38100
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shlomi Ashtar
Phone
972-4-6304930
Email
shlomia@hy.health.gov.il
First Name & Middle Initial & Last Name & Degree
Shlomo Barak, MD
12. IPD Sharing Statement
Learn more about this trial
Effects of Breezy Candy on Halitosis
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