Oral Health and Its Relation to Development and Well-being of Schoolchildren Before and After Restorative Treatments

University of Brasilia

Status: Terminated

Conditions: Dental Caries; Oral Health; Dental Atraumatic Restorative Treatment

Treatments: Other: Subjective vs objective criteria in selective excavation; Other: Glass-ionomer vs Bulk fill composites in the ART approach

Study type: Interventional

Funder types: Other

Identifiers

NCT02754466

1.400.687/2016

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 270 patients

Sex: All

Ages: 6 to 8 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Children 6-8 years old;
• Good general health;
• minimum one cavitated dentin carious lesion in a primary molar with sensible asymptomatic pulp.

Exclusion criteria

• participating in other study;
• plan to move or not residents;
• systemic disease or general disability;
• expected limited compliance; known allergy to study material; expected exfoliation of primary molars within 18 months.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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270 participants in 2 patient groups

Deep dentin lesions

Experimental group

Description:

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.

Treatment:

Other: Subjective vs objective criteria in selective excavation

Shallow and medium depth dentin lesion

Experimental group

Description:

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

Treatment:

Other: Glass-ionomer vs Bulk fill composites in the ART approach