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

Not Applicable

Completed

• Conditions: Dental Caries
• Interventions: Procedure: ART with Equia; Procedure: ART with Giomer Beautifil-Bulk Restorative

• Registration Number: NCT02962713
• Lead Sponsor: University of Sao Paulo

Brief Summary

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%.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2016-08-30
• Study First Submitted QC: 2016-11-09
• Study First Posted: 2016-11-11
• Study Start: 2017-11-06
• Primary Completion: 2019-11-20
• Study Completion: 2019-11-20
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-01
• Last Update Posted: 2021-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 182

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ART with Equia	ART with Equia	Occlusal-proximal restoration in primary molars using Equia (Easy/Quick/Unique/Intelligent/Aesthetic) from GC Corp, encapsulated, pre-dosed and mechanized handling.
ART with Giomer Beautifil-Bulk Restorative	ART with Giomer Beautifil-Bulk Restorative	Occlusal-proximal restoration in primary molars using Giomer Beautifil-Bulk Restorative (SHOFU Inc)

Primary Outcome Measures

Name	Time	Method
Longevity of atraumatic restoration using Roeleveld et al. (2006) criteria	up to 24 months	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.

Secondary Outcome Measures

Name	Time	Method
Cost-effiectiveness assessment	an average of 24 months	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.

Trial Locations

Locations (1)

University of Sao Paulo; 🇧🇷 Sao Paulo, Brazil