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

Primary Purpose

Dental Caries, Dental Atraumatic Restorative Treatment, Oral Health

Status
Terminated
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Subjective vs objective criteria in selective excavation
Glass-ionomer vs Bulk fill composites in the ART approach
Sponsored by
University of Brasilia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Caries

Eligibility Criteria

6 Years - 8 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Escolas Públicas do Paranoá / Universidade de Brasília

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Deep dentin lesions

Shallow and medium depth dentin lesion

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Survival of the restoration
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)
Quality of life - Brazilian version of the Early Childhood Oral Health Impact Scale (B-ECOHIS) Questionnaires
Treatment costs
Initial and follow-up treatment costs to allow cost-effectiveness analysis

Full Information

First Posted
April 18, 2016
Last Updated
September 28, 2021
Sponsor
University of Brasilia
Collaborators
Charite University, Berlin, Germany
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1. Study Identification

Unique Protocol Identification Number
NCT02754466
Brief Title
Oral Health and Its Relation to Development and Well-being of Schoolchildren Before and After Restorative Treatments
Official Title
Oral Health and Its Relation to Growth, Development and Well-being of Schoolchildren Before and After Restorative Treatments
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Terminated
Why Stopped
Children could not be examined longer than 2 years due to COVID-19 pandemic and schools closure.
Study Start Date
May 2, 2017 (Actual)
Primary Completion Date
March 15, 2020 (Actual)
Study Completion Date
September 28, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Brasilia
Collaborators
Charite University, Berlin, Germany

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries, Dental Atraumatic Restorative Treatment, Oral Health

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
270 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Deep dentin lesions
Arm Type
Experimental
Arm Description
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.
Arm Title
Shallow and medium depth dentin lesion
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Subjective vs objective criteria in selective excavation
Intervention Description
Subjective vs Objective criteria (Polymer burs) to perform selective excavation of dentin caries in deep lesions
Intervention Type
Other
Intervention Name(s)
Glass-ionomer vs Bulk fill composites in the ART approach
Intervention Description
High-viscosity glass-ionomer vs Bulk fill composite to restore shallow and medium depth dentin lesions using the ART approach
Primary Outcome Measure Information:
Title
Success of the restorative procedure
Description
Success of the restorative treatment, not requiring any re-intervention (as endo or extraction). Success will be measured at different time frames.
Time Frame
Through study completion, an average of 3 years
Secondary Outcome Measure Information:
Title
Survival of the restoration
Description
ART criteria for restoration survival will be used to assess survival of restoration (see Hilgert, 2014)
Time Frame
Through study completion, an average of 3 years
Title
Quality of life (and change in quality of life)
Description
Quality of life - Brazilian version of the Early Childhood Oral Health Impact Scale (B-ECOHIS) Questionnaires
Time Frame
Baseline and 12months after intervention (change in quality of life)
Title
Treatment costs
Description
Initial and follow-up treatment costs to allow cost-effectiveness analysis
Time Frame
Through study completion, an average of 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leandro A Hilgert, PhD
Organizational Affiliation
University of Brasilia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Escolas Públicas do Paranoá / Universidade de Brasília
City
Brasília
State/Province
DF
ZIP/Postal Code
70910-900
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23543523
Citation
Ricketts D, Lamont T, Innes NP, Kidd E, Clarkson JE. Operative caries management in adults and children. Cochrane Database Syst Rev. 2013 Mar 28;(3):CD003808. doi: 10.1002/14651858.CD003808.pub3.
Results Reference
background
PubMed Identifier
25132283
Citation
Hilgert LA, de Amorim RG, Leal SC, Mulder J, Creugers NH, Frencken JE. Is high-viscosity glass-ionomer-cement a successor to amalgam for treating primary molars? Dent Mater. 2014 Oct;30(10):1172-8. doi: 10.1016/j.dental.2014.07.010. Epub 2014 Aug 15.
Results Reference
background
PubMed Identifier
26331379
Citation
Schwendicke F, Stolpe M, Innes N. Conventional treatment, Hall Technique or immediate pulpotomy for carious primary molars: a cost-effectiveness analysis. Int Endod J. 2016 Sep;49(9):817-826. doi: 10.1111/iej.12537. Epub 2015 Sep 19.
Results Reference
background
PubMed Identifier
26971353
Citation
Schwendicke F, Stangvaltaite L, Holmgren C, Maltz M, Finet M, Elhennawy K, Eriksen I, Kuzmiszyn TC, Kerosuo E, Domejean S. Dentists' attitudes and behaviour regarding deep carious lesion management: a multi-national survey. Clin Oral Investig. 2017 Jan;21(1):191-198. doi: 10.1007/s00784-016-1776-5. Epub 2016 Mar 12.
Results Reference
background
PubMed Identifier
25511906
Citation
Schwendicke F, Paris S, Stolpe M. Cost-effectiveness of caries excavations in different risk groups - a micro-simulation study. BMC Oral Health. 2014 Dec 15;14:153. doi: 10.1186/1472-6831-14-153.
Results Reference
background
PubMed Identifier
21524172
Citation
De Menezes Abreu DM, Leal SC, Mulder J, Frencken JE. Dental anxiety in 6-7-year-old children treated in accordance with conventional restorative treatment, ART and ultra-conservative treatment protocols. Acta Odontol Scand. 2011 Nov;69(6):410-6. doi: 10.3109/00016357.2011.572561. Epub 2011 Apr 27.
Results Reference
background
PubMed Identifier
22824915
Citation
Frencken JE, Leal SC, Navarro MF. Twenty-five-year atraumatic restorative treatment (ART) approach: a comprehensive overview. Clin Oral Investig. 2012 Oct;16(5):1337-46. doi: 10.1007/s00784-012-0783-4. Epub 2012 Jul 24.
Results Reference
background
PubMed Identifier
21384127
Citation
de Amorim RG, Figueiredo MJ, Leal SC, Mulder J, Frencken JE. Caries experience in a child population in a deprived area of Brazil, using ICDAS II. Clin Oral Investig. 2012 Apr;16(2):513-20. doi: 10.1007/s00784-011-0528-9. Epub 2011 Mar 8.
Results Reference
background
PubMed Identifier
30552261
Citation
Schwendicke F, Leal S, Schlattmann P, Paris S, Dias Ribeiro AP, Gomes Marques M, Hilgert LA. Selective carious tissue removal using subjective criteria or polymer bur: study protocol for a randomised controlled trial (SelecCT). BMJ Open. 2018 Dec 14;8(12):e022952. doi: 10.1136/bmjopen-2018-022952.
Results Reference
derived

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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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