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

September 28, 2021 updated by: Leandro Hilgert, University of Brasilia

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

270

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • DF
      • Brasília, DF, Brazil, 70910-900
        • Escolas Públicas do Paranoá / Universidade de Brasília

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 8 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival of the restoration
Time Frame: Through study completion, an average of 3 years
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)
Time Frame: 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
Baseline and 12months after intervention (change in quality of life)
Treatment costs
Time Frame: Through study completion, an average of 3 years
Initial and follow-up treatment costs to allow cost-effectiveness analysis
Through study completion, an average of 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Brasilia

Collaborators

Charite University, Berlin, Germany

Investigators

  • Principal Investigator: Leandro A Hilgert, PhD, University of Brasilia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 2, 2017

Primary Completion (Actual)

March 15, 2020

Study Completion (Actual)

September 28, 2021

Study Registration Dates

First Submitted

April 18, 2016

First Submitted That Met QC Criteria

April 27, 2016

First Posted (Estimate)

April 28, 2016

Study Record Updates

Last Update Posted (Actual)

October 1, 2021

Last Update Submitted That Met QC Criteria

September 28, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1.400.687/2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Dental Caries

Clinical Trials on Subjective vs objective criteria in selective excavation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ecuador

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe