Giomer vs Glass Ionomer Cement for ART Occlusoproximal Restorations: a Randomized Clinical Trial

Study Overview
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Brief Summary
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Although the Atraumatic Restorative Treatment (ART) is well settled in the literature regarding occlusal-proximal cavities, the longevity of these restorations is still lower when compared to occlusal ones. This factor is often associated with low mechanical properties of glass ionomer cements (GIC). The objective of this randomized clinical trial is to evaluate the long-term cost-effectiveness of two different materials: an encapsulated GIC - Equia (GC Corp), compared with Giomer (Beautifill Bulk Restorative - Shofu) used as restoratives materials in occlusal-proximal ART restorations of primary molars. Children aged between 4 and 8 years, will be selected in schools in the city of Cerquilho, São Paulo. All restorations will be held following the precepts of the ART and the manufacturer's instructions. The restorations will be evaluated after 3, 6, 12, 18 and 24 months according to Roeleveld et al. (2006) criteria. To verify the survival of the restorations will be used Kaplan-Meier survival analysis and log rank test. To evaluate the association between the clinical variables, Cox regression test will be applied. For the cost analysis will be used analysis of variance. The level of significance for all tests will be considered to 5%.

Official Title
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Giomer vs Glass Ionomer Cement for ART Occlusoproximal Restorations: a Randomized Clinical Trial

Conditions
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Dental Caries

Intervention / Treatment
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* Procedure: ART with Equia
* Procedure: ART with Giomer Beautifil-Bulk Restorative


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children aging between 4 and 8 years Children presenting good health conditions Children whose parents or legal guardians accept and sign the consent form Children with at least one occlusal proximal caries lesion in primary molars only occlusal-proximal surfaces with caries lesions with dentin involvement Exclusion Criteria: severe behavioral issues presence of fistula or abscess near the selected tooth presence of pulp exposure in the selected tooth presence of mobility in the selected tooth

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ART with Equia<br>Occlusal-proximal restoration in primary molars using Equia (Easy/Quick/Unique/Intelligent/Aesthetic) from GC Corp, encapsulated, pre-dosed and mechanized handling. | Procedure: ART with Equia<br>* Occlusal-proximal ART restorations in primary molars using Equia (Easy/Quick/Unique/ Intelligent/Aesthetic) will be performed. No local anesthesia will be used. Infected carious tissue will be removed with hand instruments, and the cavities restored with GIC (Glass Ionomer Cement). The cavity will be filled with GIC. After the press-finger technique, the excess of material will be removed and occlusion will be checked.<br>|
| Experimental: ART with Giomer Beautifil-Bulk Restorative<br>Occlusal-proximal restoration in primary molars using Giomer Beautifil-Bulk Restorative (SHOFU Inc) | Procedure: ART with Giomer Beautifil-Bulk Restorative<br>* Occlusal-proximal ART restorations in primary molars using Giomer will be performed. No local anesthesia will be used. Infected carious tissue will be removed with hand instruments, and the cavities restored with Giomer Beautifil-Bulk Restorative and occlusion will be checked.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Longevity of atraumatic restoration using Roeleveld et al. (2006) criteria | The treatments will be classified as successful when they present a clinical satisfactory aspect. Otherwise, minor failure will be analyzed. Minor failures are those in which there is a defect in the restoration, but it does not interfere in the tooth health. | up to 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost-effiectiveness assessment | The direct cost analysis of the ART performed with the encapsulated GICs will be based on previous publications (Takanashi et al., 2004; Oscarson et al., 2003) adjusted to the Brazilian reality (Floriano et al., 2013). For this, we will consider professional cost and cost of the procedure itself. | an average of 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atraumatic Restorative Treatment, glass ionomer cement, primary teeth, dental caries.