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

Study Overview
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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.

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.

Official Title
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Performance of Glass-ionomer Cements in the Pit and Fissure Sealing and Atraumatic Restorative Treatment: a Randomized 2-year Clinical Trial

Conditions
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Dental Caries

Intervention / Treatment
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* Other: Glass ionomer
* Other: Glass ionomer cement
* Other: -Glass ionomer-
* Other: -Glass ionomer cement-


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 9 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ketac Molar® (3M/ESPE) - Glass ionomer<br>Pit and fissure sealing using conventional glass-ionomer cement | Other: Glass ionomer<br>* Application of preventive agent<br>|
| Experimental: Maxxion® (FGM) - Glass ionomer cement<br>Pit and fissure sealing using conventional glass-ionomer cement | Other: Glass ionomer cement<br>* Application of preventive agent<br>|
| Active Comparator: Ketac Molar® (3M/ESPE) - Glass ionomer -<br>Restoration using conventional glass-ionomer cement | Other: -Glass ionomer-<br>* Atraumatic Restorative Treatment<br>|
| Experimental: Maxxion® (FGM) - Glass ionomer cement -<br>Restoration using conventional glass-ionomer cement | Other: -Glass ionomer cement-<br>* Atraumatic Restorative Treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of the teeth with glass-ionomer cement retention and prevention of caries. | Criteria established by Frencken et al. (1998) was used. | 6-month | 
| Number of the teeth with good restoration and caries absence. | Criteria established by Frencken et al. (1998) was used. | 6-month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of loss of the sealing material and prevention of caries. | Criteria established by Frencken et al. (1998) was used. | 6-month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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glass-ionomer cement, atraumatic restorative treatment, pit and fissure sealants