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

University of Sao Paulo

Status: Completed

Conditions: Dental Caries

Treatments: Procedure: ART with Equia; Procedure: ART with Giomer Beautifil-Bulk Restorative

Study type: Interventional

Funder types: Other

Identifiers

NCT02962713

GIOMERART

Details and patient eligibility

About

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%.

Enrollment: 182 patients

Sex: All

Ages: 4 to 8 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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182 participants in 2 patient groups

ART with Equia

Active Comparator group

Description:

Occlusal-proximal restoration in primary molars using Equia (Easy/Quick/Unique/Intelligent/Aesthetic) from GC Corp, encapsulated, pre-dosed and mechanized handling.

Treatment:

Procedure: ART with Equia

ART with Giomer Beautifil-Bulk Restorative

Experimental group

Description:

Occlusal-proximal restoration in primary molars using Giomer Beautifil-Bulk Restorative (SHOFU Inc)

Treatment:

Procedure: ART with Giomer Beautifil-Bulk Restorative