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A Trial of Caries Prevention Effect of Fissure Sealants

NCT ID: NCT02063815

Last Updated: 2014-02-14

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

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2013-02-28

Brief Summary

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The purpose of this randomized clinical trial was to compare caries prevention of a conventional resin-based sealant and a glass-ionomer sealant placed on occlusal pits and fissures over a one year period in a high caries children group. Additionally the concentration of Fluoride in saliva was evaluated.

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Detailed Description

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Conditions

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Caries Prevention Fissure Sealant Fluoride Concentration Glass Ionomer Cement Resin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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glass ionomer based fissure sealant

fissure sealant application

Group Type ACTIVE_COMPARATOR

Fissure sealant application

Intervention Type PROCEDURE

resin based fissure sealant

fissure sealant application

Group Type ACTIVE_COMPARATOR

Fissure sealant application

Intervention Type PROCEDURE

Interventions

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Fissure sealant application

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 1.Age range of 6 to 10 years 2.Having caries free, fully erupted first permanent molars 3.Deep and/or intermediate pits or fissures 4.dft ≥ 2

Exclusion Criteria

* 1.Having any systemic disease 2.Topical fluoride was applied last six months 3.dft = 0
Minimum Eligible Age

6 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Marmara University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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SAG-A-040609-0167

Identifier Type: -

Identifier Source: org_study_id

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