Trial record 2 of 7 for:    Open Studies | "Halitosis"

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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Zinc
Propolis
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014