Effects of Breezy Candy on Halitosis (BCHS)

April 5, 2009 updated by: Breezy Industries Ltd.

Breezy Candy Halitosis Study

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

75

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Israel
      • Hadera, Israel, 38100
        • Hillel Yaffe Medical Center
        • Contact:
        • Principal Investigator:
          • Shlomo Barak, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Users of Breezy Candy will have fresher breath over Control
Time Frame: 150 minutes
150 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Breezy Industries Ltd.

Investigators

  • Principal Investigator: Shlomo Barak, MD, Mouth and Jaw institute, Hillel Yaffe Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Anticipated)

June 1, 2009

Study Completion (Anticipated)

July 1, 2009

Study Registration Dates

First Submitted

March 10, 2009

First Submitted That Met QC Criteria

April 3, 2009

First Posted (Estimate)

April 6, 2009

Study Record Updates

Last Update Posted (Estimate)

April 7, 2009

Last Update Submitted That Met QC Criteria

April 5, 2009

Last Verified

April 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BCHS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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