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

Dental Caries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02754466
• Other study ID #: 1.400.687/2016
• Status: Terminated
• Phase: N/A
• Start date: May 2, 2017
• Est. completion date: September 28, 2021

Study information

• Verified date: September 2021
• Source: University of Brasilia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 270
• Est. completion date: September 28, 2021
• Est. primary completion date: March 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 8 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dental Atraumatic Restorative Treatment
• Dental Caries
• Oral Health

Intervention

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

Locations

Country	Name	City	State
Brazil	Escolas Públicas do Paranoá / Universidade de Brasília	Brasília	DF

Sponsors (2)

Lead Sponsor	Collaborator
University of Brasilia	Charite University, Berlin, Germany

Country where clinical trial is conducted

Brazil, 

References & Publications (8)

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. — View 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. — View 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. Review. — View 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. — View 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. Review. Update in: Cochrane Database Syst Rev. 2019 Jul 24;7:CD003808. — View 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. — View Citation

Schwendicke F, Stangvaltaite L, Holmgren C, Maltz M, Finet M, Elhennawy K, Eriksen I, Kuzmiszyn TC, Kerosuo E, Doméjean 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Survival of the restoration	ART criteria for restoration survival will be used to assess survival of restoration (see Hilgert, 2014)	Through study completion, an average of 3 years
Secondary	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	Baseline and 12months after intervention (change in quality of life)
Secondary	Treatment costs	Initial and follow-up treatment costs to allow cost-effectiveness analysis	Through study completion, an average of 3 years