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| Sponsor: | Breezy Industries Ltd. |
|---|---|
| Information provided by: | Breezy Industries Ltd. |
| ClinicalTrials.gov Identifier: | NCT00875927 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Halitosis |
Other: no scraping microcapsules Other: scraping microcapsules containing inert TCP microcapsules Other: scraping microcapsules containing Propolis Other: scraping microcapsules containing and Zinc Other: scraping microcapsules containing Propolis and Zinc |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Breezy Candy Halitosis Study |
| Estimated Enrollment: | 75 |
| Study Start Date: | May 2009 |
| Estimated Study Completion Date: | July 2009 |
| Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1 - control
candy not including scraping microcapsules
|
Other: no scraping microcapsules
1, 4 grams isomalt candy containing no scraping microcapsules
|
|
Active Comparator: 2 - Scraping
candy including scraping TCP microcapsules
|
Other: scraping microcapsules containing inert TCP microcapsules
1, 4 grams isomalt candy containing 2% inert TCP scraping microcapsules
|
|
Active Comparator: 3 - Scraping plus Propolis
candy including scraping Propolis microcapsules
|
Other: scraping microcapsules containing Propolis
1, 4 grams, isomalt candy containing 2% Propolis scraping microcapsules
|
|
Active Comparator: 4 - Scraping plus Zinc
candy including scraping Zinc microcapsules
|
Other: scraping microcapsules containing and Zinc
1, 4 grams, isomalt candy containing 2% Zinc scraping microcapsules
|
|
Active Comparator: 5 - Scraping plus Propolis and Zinc
candy including scraping Propolis and Zinc microcapsules
|
Other: scraping microcapsules containing Propolis and Zinc
1, 4 grams, isomalt candy containing 2% Propolis and Zinc scraping microcapsules
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Maya Eshed, MSc, MBA | 972-54-4498669 | mayae@breezy.co.il |
| Contact: Yoram Rubin | 972-4-8342155 | info@medicguide.com |
| Israel | |
| Hillel Yaffe Medical Center | Not yet recruiting |
| Hadera, Israel, 38100 | |
| Contact: Shlomi Ashtar 972-4-6304930 shlomia@hy.health.gov.il | |
| Principal Investigator: Shlomo Barak, MD | |
| Principal Investigator: | Shlomo Barak, MD | Mouth and Jaw institute, Hillel Yaffe Medical Center |
More Information
| Responsible Party: | Maya Eshed, CEO, Breezy Industries Ltd. |
| ClinicalTrials.gov Identifier: | NCT00875927 History of Changes |
| Other Study ID Numbers: | BCHS |
| Study First Received: | March 10, 2009 |
| Last Updated: | April 5, 2009 |
| Health Authority: | Israel: Ministry of Health |
|
Halitosis |
|
Halitosis Signs and Symptoms, Digestive Signs and Symptoms Propolis Zinc Anti-Infective Agents |
Therapeutic Uses Pharmacologic Actions Trace Elements Micronutrients Growth Substances Physiological Effects of Drugs |
