Oral Health and Its Relation to Growth, Development and Well-being of Schoolchildren Before and After Restorative Treatments
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Enrollment
- 270
- Locations
- 2
- Primary Endpoint
- Success of the restorative procedure
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 6 Years to 8 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Success of the restorative procedure
Time Frame: Through study completion, an average of 3 years
Success of the restorative treatment, not requiring any re-intervention (as endo or extraction). Success will be measured at different time frames.
Secondary Outcomes
- Treatment costs(Through study completion, an average of 3 years)
- Survival of the restoration(Through study completion, an average of 3 years)
- Quality of life (and change in quality of life)(Baseline and 12months after intervention (change in quality of life))
Investigators
Leandro Hilgert
Professor of Operative Dentistry
University of Brasilia