NCT02754466

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
270

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 18, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 28, 2016

Completed
1 year until next milestone

Study Start

First participant enrolled

May 2, 2017

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2020

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 28, 2021

Completed
Last Updated

October 1, 2021

Status Verified

September 1, 2021

Enrollment Period

2.9 years

First QC Date

April 18, 2016

Last Update Submit

September 28, 2021

Conditions

Dental CariesDental Atraumatic Restorative TreatmentOral Health

Outcome Measures

Primary Outcomes (1)

  • 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.

    Through study completion, an average of 3 years

Secondary Outcomes (3)

  • Survival of the restoration

    Through study completion, an average of 3 years

  • Quality of life (and change in quality of life)

    Baseline and 12months after intervention (change in quality of life)

  • Treatment costs

    Through study completion, an average of 3 years

Study Arms (2)

Deep dentin lesions

EXPERIMENTAL

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

Shallow and medium depth dentin lesion

EXPERIMENTAL

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

Interventions

Subjective vs objective criteria in selective excavationOTHER

Subjective vs Objective criteria (Polymer burs) to perform selective excavation of dentin caries in deep lesions

Deep dentin lesions
Glass-ionomer vs Bulk fill composites in the ART approachOTHER

High-viscosity glass-ionomer vs Bulk fill composite to restore shallow and medium depth dentin lesions using the ART approach

Shallow and medium depth dentin lesion

Eligibility Criteria

Age6 Years - 8 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children 6-8 years old;
  • Good general health;
  • minimum one cavitated dentin carious lesion in a primary molar with sensible asymptomatic pulp.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Escolas Públicas do Paranoá / Universidade de Brasília

Brasília, Federal District, 70910-900, Brazil

Location

Related Publications (9)

  • 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.

    PMID: 23543523BACKGROUND

  • 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.

    PMID: 25132283BACKGROUND

  • 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.

    PMID: 26331379BACKGROUND

  • 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.

    PMID: 26971353BACKGROUND

  • 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.

    PMID: 25511906BACKGROUND

  • 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.

    PMID: 21524172BACKGROUND

  • 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.

    PMID: 22824915BACKGROUND

  • 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.

    PMID: 21384127BACKGROUND

  • 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.

    PMID: 30552261DERIVED

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Study Officials

  • Leandro A Hilgert, PhD

    University of Brasilia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Operative Dentistry

Study Record Dates

First Submitted

April 18, 2016

First Posted

April 28, 2016

Study Start

May 2, 2017

Primary Completion

March 15, 2020

Study Completion

September 28, 2021

Last Updated

October 1, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)