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Effects of Breezy Candy on Halitosis (BCHS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00875927
Recruitment Status : Unknown
Verified April 2009 by Breezy Industries Ltd..
Recruitment status was:  Not yet recruiting
First Posted : April 6, 2009
Last Update Posted : April 7, 2009
Sponsor:
Information provided by:

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.

Condition or disease Intervention/treatment 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 1 Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Breezy Candy Halitosis Study
Study Start Date : May 2009
Estimated Primary Completion Date : June 2009
Estimated Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bad Breath
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Users of Breezy Candy will have fresher breath over Control [ Time Frame: 150 minutes ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00875927


Contacts
Contact: Maya Eshed, MSc, MBA 972-54-4498669 mayae@breezy.co.il
Contact: Yoram Rubin 972-4-8342155 info@medicguide.com

Locations
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         
Sponsors and Collaborators
Breezy Industries Ltd.
Investigators
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
First Posted: April 6, 2009    Key Record Dates
Last Update Posted: April 7, 2009
Last Verified: April 2009

Keywords provided by Breezy Industries Ltd.:
Halitosis

Additional relevant MeSH terms:
Halitosis
Signs and Symptoms, Digestive
Signs and Symptoms
Zinc
Propolis
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Anti-Infective Agents