Clinical trial NCT03520309: Clinical Criteria for the Evaluation of Caries Lesions Around Restorations in Primary Teeth (CARDEC-03)
Official title: CARies DEtection in Children 03 - The Impact of Two Different Clinical Criteria for the Evaluation of Caries Lesions Around Restorations in Primary Teeth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Caries
Secondary Dental Caries
Keywords: Diagnosis
Visual inspection
Quality of Life
Restorations
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2018-05-09
Enrollment: 163
Sex: ALL
Minimum age (years): 3
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: There is still great divergence in the aspects related to caries lesions around restorations. The methods and the systems used for the detection of secondary caries lesions have presented low validity. Also, the consequent treatment decisions of this kind of lesions have presented a lot of variation. However, the correct diagnosis of secondary caries may guarantee greater longevity to the restorative treatment, as well as oral health to the patients, reducing the cost and clinical time of the dentists. Therefore, the investigators aimed to perform this study to evaluate and compare two visual criteria for the evaluation of restorations in primary teeth in medium and long term outcomes for the patients, through a randomized clinical study. These criteria are the system proposed by the World Dental Federation (FDI) and the International Caries Classification and Management System - ICCMS.

Detailed description: Among the available diagnosis criteria to detect caries lesions around restorations, there are the World Dental Federation (FDI) criteria and the International Caries Classification and Management System - ICCMS. However, few studies have evaluated the accuracy of both methods. The impact of the use of these methods in the treatment decisions regarding the restorations was also not evaluated. In relation to the detection of caries lesions around restorations in primary teeth, no randomized clinical study was performed, so the aim of this study is to establish the best diagnosis and treatment decision to caries around restorations in children. For this, three different studies will be carried out according the following specific aims: (1) to evaluate the accuracy of the FDI criteria and the system proposed by the ICCMS for the evaluation of caries lesions around restorations in primary teeth through a cross-sectional study design; (2) to evaluate the impact and cost of using these two criteria in treatment decisions related to the evaluation of restorations in primary teeth through a cross-sectional study design; (3) to evaluate the influence of the use of these two criteria for the evaluation of restorations in primary teeth in medium and long term outcomes for the patients, through a randomized clinical trial. To reach these objectives 626 restorations will be evaluated in children from 3 to 10 years who have looked for dental treatment in our dental school. They will be randomly allocated in two groups according to the diagnostic strategy used for caries detection around restorations: diagnosis and treatment decision based on the criteria of the International Dental Federation (FDI) (control group) or diagnosis and treatment decision based on the CARS detection criteria and treatment decision proposed by the ICCMS (experimental group). The consequent treatment decision of the restorations will be divided into no restorative intervention; repair or replacement of the restorations. Children will be treated by dentists, blinded to the criteria used to reach the treatment decision and then, will be monitored for two years. Reassessments will be performed by a blind examiner in relation to the child's allocation group, and the occurrence of outcomes will be assessed according to predefined criteria described for evaluation of restorations performed in the context of atraumatic restorative treatment. The primary outcome will be the need for restorative intervention during the follow-up of the restorations evaluated by the different criteria. This outcome is composed of several components. The reference standard will be the presence of caries lesion adjacent to the restoration after removal of the restoration, and their occurrence will be compared among the methods by survival analysis.

Eligibility criteria: Inclusion Criteria:

* Children who sought dental treatment in our dental school (School of Dentistry, University of Sao Paulo, Sao Paulo, Brazil)
* Children aged 3 to 6 years
* Children with at least one restoration on a primary tooth of any material, on any dental surface and regardless of its condition.

Exclusion Criteria:

* Children whose parents refuse to participate of the research
* Children who refuse to participate of the research or exhibited behavioral problems during the initial appointment
* All child's restorations will be included in the evaluation, except for restorations presenting fistula, abscess, pulp exposure, history of spontaneous dental pain or mobility.

Primary outcomes:
measure: Restoration survival
timeFrame: 24 months
Secondary outcomes:
measure: Operative treatment needs of the evaluated restorations (success of restoration)
timeFrame: 24 months.
measure: Necessity to repair the restoration
timeFrame: 24 months.
measure: Restoration replacement
timeFrame: 24 months.
measure: Presence of secondary caries lesion with dentin exposure
timeFrame: 24 months.
measure: Restored teeth that presents symptoms of pulp inflammation or episode of pain
timeFrame: 24 months.
Other outcomes:
measure: Impact of Oral Health on quality of life
timeFrame: 24 months
measure: Cost of the treatments
timeFrame: 24 months
Locations:
city: Sao Paulo
country: Brazil
facility: School of Dentistry, University of Sao Paulo
Study officials:
affiliation: School of Dentistry, University of Sao Paulo
name: Fausto M Mendes, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ismail AI, Pitts NB, Tellez M; Authors of International Caries Classification and Management System (ICCMS); Banerjee A, Deery C, Douglas G, Eggertsson H, Ekstrand K, Ellwood R, Gomez J, Jablonski-Momeni A, Kolker J, Longbottom C, Manton D, Martignon S, McGrady M, Rechmann P, Ricketts D, Sohn W, Thompson V, Twetman S, Weyant R, Wolff M, Zandona A. The International Caries Classification and Management System (ICCMS) An Example of a Caries Management Pathway. BMC Oral Health. 2015;15 Suppl 1(Suppl 1):S9. doi: 10.1186/1472-6831-15-S1-S9. Epub 2015 Sep 15. No abstract available.
citation: Hickel R, Peschke A, Tyas M, Mjor I, Bayne S, Peters M, Hiller KA, Randall R, Vanherle G, Heintze SD. FDI World Dental Federation - clinical criteria for the evaluation of direct and indirect restorations. Update and clinical examples. J Adhes Dent. 2010 Aug;12(4):259-72. doi: 10.3290/j.jad.a19262.
citation: 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.
citation: Shivakumar K, Prasad S, Chandu G. International Caries Detection and Assessment System: A new paradigm in detection of dental caries. J Conserv Dent. 2009 Jan;12(1):10-6. doi: 10.4103/0972-0707.53335.
citation: Roeleveld AC, van Amerongen WE, Mandari GJ. Influence of residual caries and cervical gaps on the survival rate of Class II glass ionomer restorations. Eur Arch Paediatr Dent. 2006 Jun;7(2):85-91. doi: 10.1007/BF03320820.
citation: Olegario IC, Moro BLP, Tedesco TK, Freitas RD, Passaro AL, Garbim JR, Oliveira R, Mendes FM; CARDEC 03 collaborative group; Raggio DP. Use of rubber dam versus cotton roll isolation on composite resin restorations' survival in primary molars: 2-year results from a non-inferiority clinical trial. BMC Oral Health. 2022 Oct 10;22(1):440. doi: 10.1186/s12903-022-02449-y.
citation: Moro BLP, Pontes LRA, Maia HC, Freitas RD, Tedesco TK, Raggio DP, Braga MM, Ekstrand KR, Imparato JCP, Cenci MS, Mendes FM. Clinical Accuracy of Two Different Criteria for the Detection of Caries Lesions around Restorations in Primary Teeth. Caries Res. 2022;56(2):98-108. doi: 10.1159/000523951. Epub 2022 May 3.
citation: Freitas RD, Moro BLP, Pontes LRA, Maia HCM, Passaro AL, Oliveira RC, Garbim JR, Vigano MEF, Tedesco TK, Deery C, Raggio DP, Cenci MS, Mendes FM, Braga MM; CARDEC collaborative group - CARDEC-03 trial. The economic impact of two diagnostic strategies in the management of restorations in primary teeth: a health economic analysis plan for a trial-based economic evaluation. Trials. 2021 Nov 12;22(1):794. doi: 10.1186/s13063-021-05722-7.
citation: Moro BLP, Signori C, Freitas RD, Pontes LRA, Lenzi TL, Tedesco TK, Raggio DP, Braga MM, Ekstrand KR, Cenci MS, Mendes FM; CARDEC collaborative group; CaCIA collaborative group. The effect of two clinical criteria in the assessment of caries lesions around restorations in children (CARDEC-03): study protocol for a diagnostic randomized clinical trial. F1000Res. 2020 Jun 26;9:650. doi: 10.12688/f1000research.23801.3. eCollection 2020.