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NCT00875927 Clinical Trial

Effects of Breezy Candy on Halitosis

Halitosis Clinical Trial

— BCHS  

Official title:
Breezy Candy Halitosis Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT00875927
Other study ID # BCHS
Secondary ID
Status Not yet recruiting
Phase Phase 1/Phase 2
First received March 10, 2009
Last updated April 5, 2009
Start date May 2009
Est. completion date July 2009

Study information
Verified date April 2009
Source Breezy Industries Ltd.
Contact Maya Eshed, MSc, MBA
Phone 972-54-4498669
Email mayae@breezy.co.il
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Interventional

Clinical 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 75
Est. completion date July 2009
Est. primary completion date June 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 75 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Other:
• no scraping microcapsules
1, 4 grams isomalt candy containing no scraping microcapsules
• scraping microcapsules containing inert TCP microcapsules
1, 4 grams isomalt candy containing 2% inert TCP scraping microcapsules
• scraping microcapsules containing Propolis
1, 4 grams, isomalt candy containing 2% Propolis scraping microcapsules
• scraping microcapsules containing and Zinc
1, 4 grams, isomalt candy containing 2% Zinc scraping microcapsules
• scraping microcapsules containing Propolis and Zinc
1, 4 grams, isomalt candy containing 2% Propolis and Zinc scraping microcapsules

Locations
Country Name City State
Israel Hillel Yaffe Medical Center Hadera

Sponsors (1)
Lead Sponsor Collaborator
Breezy Industries Ltd.

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Users of Breezy Candy will have fresher breath over Control 150 minutes Yes
See also
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