An interventional study of Subjective vs objective criteria in selective excavation and Glass-ionomer vs Bulk fill composites in the ART approach in Dental Caries, Dental Atraumatic Restorative Treatment and Oral Health, sponsored by University of Brasilia. Terminated at 1 site in Brazil. Open to participants aged 6 Years to 8 Years. Per ClinicalTrials.gov, last updated 2021-10-01.
Sponsored by University of Brasilia · Not applicable, Interventional, and Treatment
The present study aims evaluate the oral health conditions of schoolchildren and its relation to growth, development and well-being. Also, it seeks to evaluate different restorative interventions performed at school premises in primary teeth and its impact on the quality of life.
Schoolchildren, aged 6-8 years old, from the six public schools of a deprived suburban area of Brasília, Brazil will be recruited. In the stage 1 of the study, an epidemiological survey of the oral health status and an anthropometric evaluation of the children will be performed. Potential patient for study's stage 2 will be recruited. Quality of life surveys, patterns of oral hygiene and socio-demographic data will be collected.
Children with restorative treatment needs will be included in the study's stage 2. In this second stage, primary molars with deep dentin lesions will be treated according to two techniques for selective excavation of carious dentin: subjective criteria or using an objective criteria (polymer burs). For both groups restorations will be performed using a high-viscosity glass-ionomer. In shallow and medium depth dentin lesions, carious dentin will be excavated using hand instruments only (ART approach) and restored using two materials: a high-viscosity glass-ionomer or a combination of a self-etch adhesive and a bulk fill composite.
All children will be followed up (study's stage 3) to assess efficacy of the restorative interventions and impact of the restorative treatment on children's quality of life and development.
1,109 studies on the registry are indexed under Dental Caries; 197 are open to participants now.
This study's enrollment of 270 is above the median of 60 across 916 interventional studies indexed under Dental Caries.
Browse Dental Caries studies →University of Brasilia is the lead sponsor of 63 studies on the registry; 11 are open to participants now.
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Exclusion Criteria:
Subjective vs objective criteria in selective excavation of carious lesions Group 1: selective carious dentin excavation using subjective criteria (standard protocol in Dentistry) Group 2: selective carious dentin excavation using objective criteria (polymer burs) All restorations performed using high-viscosity glass-ionomer.
Other: Subjective vs objective criteria in selective excavation
Glass-ionomer vs Bulk fill composites in the ART approach All cavities excavated using hand-instruments only (ART approach) Group 1: restorations using high-viscosity glass-ionomer Group 2: restorations using self-etch adhesive and bulk fill composite
Other: Glass-ionomer vs Bulk fill composites in the ART approach
Subjective vs Objective criteria (Polymer burs) to perform selective excavation of dentin caries in deep lesions
High-viscosity glass-ionomer vs Bulk fill composite to restore shallow and medium depth dentin lesions using the ART approach
Success of the restorative procedure
Success of the restorative treatment, not requiring any re-intervention (as endo or extraction). Success will be measured at different time frames.
Time frame: Through study completion, an average of 3 years
Survival of the restoration
ART criteria for restoration survival will be used to assess survival of restoration (see Hilgert, 2014)
Time frame: Through study completion, an average of 3 years
Quality of life (and change in quality of life)
Quality of life - Brazilian version of the Early Childhood Oral Health Impact Scale (B-ECOHIS) Questionnaires
Time frame: Baseline and 12months after intervention (change in quality of life)
Treatment costs
Initial and follow-up treatment costs to allow cost-effectiveness analysis
Time frame: Through study completion, an average of 3 years
Plan to share: No
This study is terminated, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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University of Brasilia