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Effects of a Chewing Gum Containing POs-Ca and Fluoride on Enamel

This study has been completed.
Sponsor:
Information provided by:
Tokyo Medical and Dental University
ClinicalTrials.gov Identifier:
NCT01377493
First received: June 17, 2011
Last updated: June 20, 2011
Last verified: June 2011
History of Changes
  Purpose

There were no differences in the degree of enamel remineralization of subsurface lesions among the chewing gums containing or not containing POs-Ca and fluoride.


Condition Intervention Phase
Enamel Subsurface Lesion
 Dietary Supplement: chewing gum
 Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of a Chewing Gum Containing POs-Ca and Fluoride on Remineralization of Enamel Subsurface Lesions in Situ

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Tokyo Medical and Dental University:

Primary Outcome Measures:
  • Mineral content of enamel [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Mineral content of bovine enamel blocks inserted into the subject mouth during chewing of the gums was assessed.


Enrollment: 36
Study Start Date: December 2009
Study Completion Date: June 2011
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: placebo Dietary Supplement: chewing gum
chewing gum containing no active ingredients, or Ca-P bioavailable ions, or Ca-P and F bioavailable ions
Active Comparator: POs-Ca Dietary Supplement: chewing gum
chewing gum containing no active ingredients, or Ca-P bioavailable ions, or Ca-P and F bioavailable ions
Active Comparator: POs-Ca+F Dietary Supplement: chewing gum
chewing gum containing no active ingredients, or Ca-P bioavailable ions, or Ca-P and F bioavailable ions

  Eligibility

Ages Eligible for Study:   20 Years to 31 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy adult subjects
  • More than 22 permanent teeth

Exclusion Criteria:

  • Alcohol addiction
  • Smoking
  • Active caries
  • Periodontal pockets
  • Low-saliva flow (less than 0.3ml/min)
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided by Tokyo Medical and Dental University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Yuichi Kitasako, Tokyo Medical and Dental University
ClinicalTrials.gov Identifier: NCT01377493     History of Changes
Other Study ID Numbers: 1B116
Study First Received: June 17, 2011
Last Updated: June 20, 2011
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Tokyo Medical and Dental University:
chewing-gum
enamel subsurface lesion
calcium additives
fluoride
in situ

Additional relevant MeSH terms:
Fluorides
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013