Performance of Glass-ionomer Cements: 2-year Follow-up

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

PHASE1

Total Enrollment

147 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2010-08-31

Brief Summary

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The purpose of this randomized clinical trial was evaluate the performance of two conventional glass-ionomer cements in the pit and fissure sealing and atraumatic restorative treatment in high caries risk children.

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Detailed Description

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Sealants were applied on sound permanent first molars by "press finger technique" and carious deciduous molars that required either class I or class II restorations were restored according to manufacturers' recommendations in order to caries prevention and control.

Conditions

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Dental Caries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

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Ketac Molar® (3M/ESPE) - Glass ionomer

Pit and fissure sealing using conventional glass-ionomer cement

Group Type ACTIVE_COMPARATOR

Glass ionomer

Intervention Type OTHER

Application of preventive agent

Maxxion® (FGM) - Glass ionomer cement

Pit and fissure sealing using conventional glass-ionomer cement

Group Type EXPERIMENTAL

Glass ionomer cement

Intervention Type OTHER

Application of preventive agent

Ketac Molar® (3M/ESPE) - Glass ionomer -

Restoration using conventional glass-ionomer cement

Group Type ACTIVE_COMPARATOR

-Glass ionomer-

Intervention Type OTHER

Atraumatic Restorative Treatment

Maxxion® (FGM) - Glass ionomer cement -

Restoration using conventional glass-ionomer cement

Group Type EXPERIMENTAL

-Glass ionomer cement-

Intervention Type OTHER

Atraumatic Restorative Treatment

Interventions

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Glass ionomer

Application of preventive agent

Intervention Type OTHER

Glass ionomer cement

Application of preventive agent

Intervention Type OTHER

-Glass ionomer-

Atraumatic Restorative Treatment

Intervention Type OTHER

-Glass ionomer cement-

Atraumatic Restorative Treatment

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Volunteers that having at least two permanent first molars of opposite sides of the mouth, erupted in the oral cavity, caries-free and high-risk disease (presence of white spots, history of caries, plaque in smooth surfaces and gingivitis);
* Children who had one or two bilateral matched pairs of carious deciduous molars that required either class I or class II restorations.

Exclusion Criteria

* Children who did not meet the minimum requirements for the achievement of sealants or parents / guardians did not agree to participate;
* No history of spontaneous pulpal pain.

Minimum Eligible Age

5 Years

Maximum Eligible Age

9 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes