Oral Health and Its Relation to Development and Well-being of Schoolchildren Before and After Restorative Treatments
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02754466|
Recruitment Status : Recruiting
First Posted : April 28, 2016
Last Update Posted : May 3, 2017
|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|
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|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|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|
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
- 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.
- 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)
- 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
- Treatment costs [ Time Frame: Through study completion, an average of 3 years ]Initial and follow-up treatment costs to allow cost-effectiveness analysis
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
|Contact: Leandro A Hilgert, PhD||+55(61)email@example.com|
|Contact: Soraya C Leal, PhD||+55(61) firstname.lastname@example.org|
|Escolas Públicas do Paranoá / Universidade de Brasília||Recruiting|
|Brasília, DF, Brazil, 70910-900|
|Contact: Leandro A Hilgert, PhD email@example.com|
|Contact: Soraya C Leal, PhD firstname.lastname@example.org|