NCT00875927

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started May 2009

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 10, 2009

Completed
27 days until next milestone

First Posted

Study publicly available on registry

April 6, 2009

Completed
25 days until next milestone

Study Start

First participant enrolled

May 1, 2009

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

April 7, 2009

Status Verified

April 1, 2009

Enrollment Period

1 month

First QC Date

March 10, 2009

Last Update Submit

April 5, 2009

Conditions

Keywords

Halitosis

Outcome Measures

Primary Outcomes (1)

  • Users of Breezy Candy will have fresher breath over Control

    150 minutes

Study Arms (5)

1 - control

ACTIVE COMPARATOR

candy not including scraping microcapsules

Other: no scraping microcapsules

2 - Scraping

ACTIVE COMPARATOR

candy including scraping TCP microcapsules

Other: scraping microcapsules containing inert TCP microcapsules

3 - Scraping plus Propolis

ACTIVE COMPARATOR

candy including scraping Propolis microcapsules

Other: scraping microcapsules containing Propolis

4 - Scraping plus Zinc

ACTIVE COMPARATOR

candy including scraping Zinc microcapsules

Other: scraping microcapsules containing and Zinc

5 - Scraping plus Propolis and Zinc

ACTIVE COMPARATOR

candy including scraping Propolis and Zinc microcapsules

Other: scraping microcapsules containing Propolis and Zinc

Interventions

1, 4 grams isomalt candy containing no scraping microcapsules

1 - control

1, 4 grams isomalt candy containing 2% inert TCP scraping microcapsules

2 - Scraping

1, 4 grams, isomalt candy containing 2% Propolis scraping microcapsules

3 - Scraping plus Propolis

1, 4 grams, isomalt candy containing 2% Zinc scraping microcapsules

4 - Scraping plus Zinc

1, 4 grams, isomalt candy containing 2% Propolis and Zinc scraping microcapsules

5 - Scraping plus Propolis and Zinc

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adult
  • healthy
  • male
  • female
  • bad breath

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hillel Yaffe Medical Center

Hadera, 38100, Israel

Location

MeSH Terms

Conditions

Halitosis

Interventions

Zinc

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Metals, HeavyElementsInorganic ChemicalsTransition ElementsMetals

Study Officials

  • Shlomo Barak, MD

    Mouth and Jaw institute, Hillel Yaffe Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Maya Eshed, MSc, MBA

CONTACT

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 10, 2009

First Posted

April 6, 2009

Study Start

May 1, 2009

Primary Completion

June 1, 2009

Study Completion

July 1, 2009

Last Updated

April 7, 2009

Record last verified: 2009-04

Locations