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

Not Applicable

Terminated

• Conditions: Dental Atraumatic Restorative Treatment; Dental Caries; Oral Health
• Interventions: Other: Glass-ionomer vs Bulk fill composites in the ART approach; Other: Subjective vs objective criteria in selective excavation

• Registration Number: NCT02754466
• Lead Sponsor: University of Brasilia

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 Timeline

• Study First Submitted: 2016-04-18
• Study First Submitted QC: 2016-04-27
• Study First Posted: 2016-04-28
• Study Start: 2017-05-02
• Primary Completion: 2020-03-15
• Status Verified: 2021-09
• Study Completion: 2021-09-28
• Last Update Submitted: 2021-09-28
• Last Update Posted: 2021-10-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 270

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Shallow and medium depth dentin lesion	Glass-ionomer vs Bulk fill composites in the ART approach	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
Deep dentin lesions	Subjective vs objective criteria in selective excavation	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.

Primary Outcome Measures

Name	Time	Method
Success of the restorative procedure	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 Outcome Measures

Name	Time	Method
Treatment costs	Through study completion, an average of 3 years	Initial and follow-up treatment costs to allow cost-effectiveness analysis
Survival of the restoration	Through study completion, an average of 3 years	ART criteria for restoration survival will be used to assess survival of restoration (see Hilgert, 2014)
Quality of life (and change in quality of life)	Baseline and 12months after intervention (change in quality of life)	Quality of life - Brazilian version of the Early Childhood Oral Health Impact Scale (B-ECOHIS) Questionnaires

Trial Locations

Locations (1)

Escolas Públicas do Paranoá / Universidade de Brasília; 🇧🇷 Brasília, DF, Brazil