Effects of Breezy Candy on Halitosis (BCHS)

The recruitment status of this study is unknown because the information has not been verified recently.

Verified April 2009 by Breezy Industries Ltd..
Recruitment status was Not yet recruiting

Sponsor:

Information provided by:

Breezy Industries Ltd.

ClinicalTrials.gov Identifier:

NCT00875927

First received: March 10, 2009

Last updated: April 5, 2009

Last verified: April 2009

History of Changes

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 1 Phase 2

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

Resource links provided by NLM:

MedlinePlus related topics: Bad Breath

U.S. FDA Resources

Further study details as provided by Breezy Industries Ltd.:

Primary Outcome Measures:

Users of Breezy Candy will have fresher breath over Control [ Time Frame: 150 minutes ] [ Designated as safety issue: Yes ]

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

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

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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

Keywords provided by Breezy Industries Ltd.:

Halitosis

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on May 16, 2013

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