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

NCT ID: NCT01377493

Last Updated: 2011-06-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2011-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Enamel Subsurface Lesion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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placebo

Group Type PLACEBO_COMPARATOR

chewing gum

Intervention Type DIETARY_SUPPLEMENT

chewing gum containing no active ingredients, or Ca-P bioavailable ions, or Ca-P and F bioavailable ions

POs-Ca

Group Type ACTIVE_COMPARATOR

chewing gum

Intervention Type DIETARY_SUPPLEMENT

chewing gum containing no active ingredients, or Ca-P bioavailable ions, or Ca-P and F bioavailable ions

POs-Ca+F

Group Type ACTIVE_COMPARATOR

chewing gum

Intervention Type DIETARY_SUPPLEMENT

chewing gum containing no active ingredients, or Ca-P bioavailable ions, or Ca-P and F bioavailable ions

Interventions

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chewing gum

chewing gum containing no active ingredients, or Ca-P bioavailable ions, or Ca-P and F bioavailable ions

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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)
Minimum Eligible Age

20 Years

Maximum Eligible Age

31 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tokyo Medical and Dental University

OTHER

Sponsor Role lead

Responsible Party

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Tokyo Medical and Dental University

References

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Kitasako Y, Sadr A, Hamba H, Ikeda M, Tagami J. Gum containing calcium fluoride reinforces enamel subsurface lesions in situ. J Dent Res. 2012 Apr;91(4):370-5. doi: 10.1177/0022034512439716. Epub 2012 Feb 15.

Reference Type DERIVED
PMID: 22337700 (View on PubMed)

Kitasako Y, Tanaka M, Sadr A, Hamba H, Ikeda M, Tagami J. Effects of a chewing gum containing phosphoryl oligosaccharides of calcium (POs-Ca) and fluoride on remineralization and crystallization of enamel subsurface lesions in situ. J Dent. 2011 Nov;39(11):771-9. doi: 10.1016/j.jdent.2011.08.009. Epub 2011 Aug 19.

Reference Type DERIVED
PMID: 21875640 (View on PubMed)

Other Identifiers

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1B116

Identifier Type: -

Identifier Source: org_study_id

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