NCT02754466

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

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 270 (actual)
• Sponsor: University of Brasilia · Academic / Other
• Sex: All
• Age: 6 Years – 8 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Dental Caries
• Dental Atraumatic Restorative Treatment
• Oral Health

Interventions

Type	Name	Description
OTHER	Subjective vs objective criteria in selective excavation	Subjective vs Objective criteria (Polymer burs) to perform selective excavation of dentin caries in deep lesions
OTHER	Glass-ionomer vs Bulk fill composites in the ART approach	High-viscosity glass-ionomer vs Bulk fill composite to restore shallow and medium depth dentin lesions using the ART approach

Timeline

• Start date: 2017-05-02
• Primary completion: 2020-03-15
• Completion: 2021-09-28
• First posted: 2016-04-28
• Last updated: 2021-10-01

Locations

1 site across 1 country: Brazil