Clinical trial NCT02962713: Giomer vs Glass Ionomer Cement for ART Occlusoproximal Restorations: a Randomized Clinical Trial
Official title: Giomer vs Glass Ionomer Cement for ART Occlusoproximal Restorations: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Caries
Keywords: Atraumatic Restorative Treatment
glass ionomer cement
primary teeth
dental caries.
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2016-11-11
Enrollment: 182
Sex: ALL
Minimum age (years): 4
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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%.


Eligibility criteria: 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

Primary outcomes:
measure: Longevity of atraumatic restoration using Roeleveld et al. (2006) criteria
timeFrame: up to 24 months
Secondary outcomes:
measure: Cost-effiectiveness assessment
timeFrame: an average of 24 months
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: University of Sao Paulo
Study officials:
affiliation: University of Sao Paulo
name: Daniela P Raggio, Professor
role: PRINCIPAL_INVESTIGATOR
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