Impact of Detecting Initial and Active Caries Lesions in Primary Teeth

NCT02473107 | Completed DMC

• 1 other identifier: CARDEC-02
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

Brief Summary

The present study aims to evaluate the impact of detecting active initial caries lesions in primary teeth regarding effectiveness, cost-effectiveness, applicability (acceptability and satisfaction) and quality of life. For this, 248 children 3-6 years with complete primary dentition will be examined and treated in a mobile dental unit, which will temporarily be parked in public schools of Sao Paulo. The caries detection will be conducted using the International Caries Detection and Assessment System (ICDAS) and, depending on allocation, an adjunct criterion for caries activity assessment. Children will be randomized in two groups according to the caries threshold to be detected: Group A (only advanced lesions will be detected and treated, independently of their activity status) and Group B (all caries lesions, including initial ones, will be detected and all active lesions will be treated). After this, the treatment plan for each child will be made according to strategies mentioned above. Data concerning the cost-effectiveness of the procedures, acceptability / satisfaction of children and quality of life will be collected after diagnosis, after the end of treatment and 12 and 24 months from the initial examination. For comparison between groups, multilevel regression analyses will be performed. The primary outcome will be sites which need of operative treatment during the follow-up periods and the secondary outcomes will be the cost-effectiveness of each strategy, the acceptability / satisfaction of the child and the impact on quality of life.

Conditions

Dental Caries

Keywords

Dental caries; Primary tooth; Caries Detection

Outcome Measures

Primary Outcomes (1)

• Incremental number of dental surfaces with operative treatment needs

  This outcome will be assessed by the new caries lesions and / or progression of lesions previously diagnosed / treated and number of treated surfaces which will need restoration replacement, endodontic treatment or extraction after the initial treatment.

  After 12 and 24 months from allocation

Secondary Outcomes (3)

• Cost-efficacy

  After 12 and 24 months from the allocation

• Discomfort

  immediately after the allocation and after 12 and 24 months

• Impact of oral health on quality of life

  12 and 24 months after the allocation

Other Outcomes (1)

• Costs

  Immediately after allocation

Study Arms (2)

Control Caries Detection Strategy

OTHER

Detection and treatment based on more advanced lesions, despite activity status - Advanced caries lesions detection (no activity assessment)

Other: Advanced caries lesions detection (no activity assessment)

Test Caries Detection Strategy

OTHER

Detection and treatment based on all detected caries lesions, considering their activity status as a differential in clinical decision-making - All caries lesions detection (+activity assessment)

Other: All caries lesions detection (+activity assessment)

Interventions

Advanced caries lesions detection (no activity assessment) OTHER

The diagnosis strategy will based on detection of only moderate and advanced caries lesions (ICDAS scores 3 to 6). Initial caries lesions will be considered as sound surfaces. Caries activity status will not be evaluated. Clinical decision-making will be proposed for all lesions detected, based on evidence-based protocols.

Also known as: WHO criteria, Advanced caries lesions, Extensive Decays

Control Caries Detection Strategy

All caries lesions detection (+activity assessment) OTHER

The diagnosis strategy will based on detection of initial, moderate and advanced caries lesions (ICDAS scores 1 to 6). Caries activity status will be also evaluated. Clinical decision-making will be proposed for all active lesions detected, based on evidence-based protocols. inactive caries lesions will not be treated.

Also known as: Caries activity assessment, initial caries lesions, early detection

Test Caries Detection Strategy

Eligibility Criteria

• Age: 36 Months - 83 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Individuals aged 36 months to 83 months;
• Should have complete primary dentition;
• Children must assent to participate and their parents must consent to their participation by signing the consent form.

You may not qualify if:

• Medical and/or behavioral conditions that requires special considerations regarding management/treatment of the child;
• Children involved in other research that may impact on this study;
• Families who are expected to move out of the coverage area of study during the first year of enrollment.

Sponsors & Collaborators

• University of Sao Paulo: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator
• Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.: collaborator

Study Sites (1)

University of Sao Paulo

São Paulo, 05508000, Brazil

Location

Related Publications (20)

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  PMID: 9088694 BACKGROUND

• Nyvad B. Diagnosis versus detection of caries. Caries Res. 2004 May-Jun;38(3):192-8. doi: 10.1159/000077754.

  PMID: 15153688 BACKGROUND

• Baelum V, Heidmann J, Nyvad B. Dental caries paradigms in diagnosis and diagnostic research. Eur J Oral Sci. 2006 Aug;114(4):263-77. doi: 10.1111/j.1600-0722.2006.00383.x.

  PMID: 16911097 BACKGROUND

• Ismail AI. Clinical diagnosis of precavitated carious lesions. Community Dent Oral Epidemiol. 1997 Feb;25(1):13-23. doi: 10.1111/j.1600-0528.1997.tb00895.x.

  PMID: 9088688 BACKGROUND

• Pitts NB. Are we ready to move from operative to non-operative/preventive treatment of dental caries in clinical practice? Caries Res. 2004 May-Jun;38(3):294-304. doi: 10.1159/000077769.

  PMID: 15153703 BACKGROUND

• Ekstrand KR. Improving clinical visual detection--potential for caries clinical trials. J Dent Res. 2004;83 Spec No C:C67-71. doi: 10.1177/154405910408301s13.

  PMID: 15286125 BACKGROUND

• Kidd E, Fejerskov O. Changing concepts in cariology: forty years on. Dent Update. 2013 May;40(4):277-8, 280-2, 285-6. doi: 10.12968/denu.2013.40.4.277.

  PMID: 23829008 BACKGROUND

• Baelum V, Machiulskiene V, Nyvad B, Richards A, Vaeth M. Application of survival analysis to carious lesion transitions in intervention trials. Community Dent Oral Epidemiol. 2003 Aug;31(4):252-60. doi: 10.1034/j.1600-0528.2003.00045.x.

  PMID: 12846847 BACKGROUND

• Ismail AI, Sohn W, Tellez M, Amaya A, Sen A, Hasson H, Pitts NB. The International Caries Detection and Assessment System (ICDAS): an integrated system for measuring dental caries. Community Dent Oral Epidemiol. 2007 Jun;35(3):170-8. doi: 10.1111/j.1600-0528.2007.00347.x.

  PMID: 17518963 BACKGROUND

• Piovesan C, Ardenghi TM, Guedes RS, Ekstrand KR, Braga MM, Mendes FM. Activity assessment has little impact on caries parameters reduction in epidemiological surveys with preschool children. Community Dent Oral Epidemiol. 2013 Jun;41(3):204-11. doi: 10.1111/cdoe.12004. Epub 2012 Sep 25.

  PMID: 23004568 BACKGROUND

• Mendes FM, Braga MM, Oliveira LB, Antunes JL, Ardenghi TM, Bonecker M. Discriminant validity of the International Caries Detection and Assessment System (ICDAS) and comparability with World Health Organization criteria in a cross-sectional study. Community Dent Oral Epidemiol. 2010 Oct;38(5):398-407. doi: 10.1111/j.1600-0528.2010.00557.x.

  PMID: 20636415 BACKGROUND

• Walsh T, Worthington HV, Glenny AM, Appelbe P, Marinho VC, Shi X. Fluoride toothpastes of different concentrations for preventing dental caries in children and adolescents. Cochrane Database Syst Rev. 2010 Jan 20;(1):CD007868. doi: 10.1002/14651858.CD007868.pub2.

  PMID: 20091655 BACKGROUND

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  PMID: 22736448 BACKGROUND

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  PMID: 16856019 BACKGROUND

• JOE Editorial Board. Treatment of the primary tooth: an online study guide. J Endod. 2008 May;34(5 Suppl):e107-10. doi: 10.1016/j.joen.2007.08.004.

  PMID: 18457686 BACKGROUND

• Garber AM, Phelps CE. Economic foundations of cost-effectiveness analysis. J Health Econ. 1997 Feb;16(1):1-31. doi: 10.1016/s0167-6296(96)00506-1.

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• Martins-Junior PA, Ramos-Jorge J, Paiva SM, Marques LS, Ramos-Jorge ML. Validations of the Brazilian version of the Early Childhood Oral Health Impact Scale (ECOHIS). Cad Saude Publica. 2012 Feb;28(2):367-74. doi: 10.1590/s0102-311x2012000200015.

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• Floriano I, Bonini GC, Matos R, Novaes TF, Ekstrand KR, Mendes FM, Braga MM. How different do visuo-tactile criteria assess caries lesions activity status on occlusal surfaces? Oral Dis. 2015 Apr;21(3):299-307. doi: 10.1111/odi.12265. Epub 2014 Aug 14.

  PMID: 24912618 RESULT

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Mariana M Braga

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

• Isabela Floriano

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

• Fausto M Mendes

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Senior Lecturer

Study Record Dates

• First Submitted: June 9, 2015
• First Posted: June 16, 2015
• Study Start: September 1, 2015
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2018
• Last Updated: December 28, 2022

Record last verified: 2022-12

Locations

BR (1)