An interventional study of ART with Equia and ART with Giomer Beautifil-Bulk Restorative in Dental Caries, sponsored by University of Sao Paulo. Completed at 1 site in Brazil. Open to participants aged 4 Years to 8 Years. Per ClinicalTrials.gov, last updated 2021-03-03.
Sponsored by University of Sao Paulo · Not applicable, Interventional, and Treatment
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%.
1,109 studies on the registry are indexed under Dental Caries; 197 are open to participants now.
This study's enrollment of 182 is above the median of 60 across 916 interventional studies indexed under Dental Caries.
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Exclusion Criteria:
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
Occlusal-proximal restoration in primary molars using Giomer Beautifil-Bulk Restorative (SHOFU Inc)
Procedure: ART with Giomer Beautifil-Bulk Restorative
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.
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.
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.
Time frame: up to 24 months
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.
Time frame: an average of 24 months
Plan to share: No
This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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University of Sao Paulo