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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Dental Caries, Dental Atraumatic Restorative Treatment, Oral Health

Intervention / Treatment
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* Other: Subjective vs objective criteria in selective excavation
* Other: Glass-ionomer vs Bulk fill composites in the ART approach


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Deep dentin lesions<br>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<br>* Subjective vs Objective criteria (Polymer burs) to perform selective excavation of dentin caries in deep lesions<br>|
| Experimental: Shallow and medium depth dentin lesion<br>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<br>* High-viscosity glass-ionomer vs Bulk fill composite to restore shallow and medium depth dentin lesions using the ART approach<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Through study completion, an average of 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival of the restoration | ART criteria for restoration survival will be used to assess survival of restoration (see Hilgert, 2014) | 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 | Baseline and 12months after intervention (change in quality of life) | 
| Treatment costs | Initial and follow-up treatment costs to allow cost-effectiveness analysis | Through study completion, an average of 3 years |