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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01377493
First Posted: June 21, 2011
Last Update Posted: June 21, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Tokyo Medical and Dental University
  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 Early Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, 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:


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

Primary Outcome Measures:
  • Mineral content of enamel [ Time Frame: 2 weeks ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 31 Years   (Adult)
Sexes Eligible for Study:   All
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

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
First Submitted: June 17, 2011
First Posted: June 21, 2011
Last Update Posted: June 21, 2011
Last Verified: June 2011

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