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

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ClinicalTrials.gov Identifier: NCT02754466
Recruitment Status : Recruiting
First Posted : April 28, 2016
Last Update Posted : May 3, 2017
Sponsor:
Collaborator:
Charite University, Berlin, Germany
Information provided by (Responsible Party):
Leandro Hilgert, 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.

Condition or disease Intervention/treatment Phase
Dental Caries Dental Atraumatic Restorative Treatment Oral Health Other: Subjective vs objective criteria in selective excavation Other: Glass-ionomer vs Bulk fill composites in the ART approach Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Oral Health and Its Relation to Growth, Development and Well-being of Schoolchildren Before and After Restorative Treatments
Actual Study Start Date : May 2, 2017
Estimated Primary Completion Date : May 2, 2018
Estimated Study Completion Date : May 2, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dental Health

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




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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)

  2. 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

  3. Treatment costs [ Time Frame: Through study completion, an average of 3 years ]
    Initial and follow-up treatment costs to allow cost-effectiveness analysis



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Ages Eligible for Study:   6 Years to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02754466


Contacts
Contact: Leandro A Hilgert, PhD +55(61)32028350 leandrohilgert@gmail.com
Contact: Soraya C Leal, PhD +55(61) 31071802 sorayaodt@yahoo.com

Locations
Brazil
Escolas Públicas do Paranoá / Universidade de Brasília Recruiting
Brasília, DF, Brazil, 70910-900
Contact: Leandro A Hilgert, PhD       leandrohilgert@gmail.com   
Contact: Soraya C Leal, PhD       sorayaodt@yahoo.com   
Sponsors and Collaborators
University of Brasilia
Charite University, Berlin, Germany

Publications:

Responsible Party: Leandro Hilgert, Professor of Operative Dentistry, University of Brasilia
ClinicalTrials.gov Identifier: NCT02754466     History of Changes
Other Study ID Numbers: 1.400.687/2016
First Posted: April 28, 2016    Key Record Dates
Last Update Posted: May 3, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases