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

June 20, 2011 updated by: Tokyo Medical and Dental University

Effects of a Chewing Gum Containing POs-Ca and Fluoride on Remineralization of Enamel Subsurface Lesions in Situ

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Early Phase 1

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

20 years to 31 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

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: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 weeks

Collaborators and Investigators

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

Sponsor

Tokyo Medical and Dental University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

December 1, 2009

Primary Completion (Actual)

February 1, 2010

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

June 17, 2011

First Submitted That Met QC Criteria

June 20, 2011

First Posted (Estimate)

June 21, 2011

Study Record Updates

Last Update Posted (Estimate)

June 21, 2011

Last Update Submitted That Met QC Criteria

June 20, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1B116

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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