Clinical Criteria for the Evaluation of Caries Lesions Around Restorations in Primary Teeth (CARDEC-03)

U

University of Sao Paulo

Status

Completed

Conditions

Dental Caries
Secondary Dental Caries

Treatments

Procedure: Dental treatment

Study type

Interventional

Funder types

Other

Identifiers

NCT03520309
CARDEC-03

Details and patient eligibility

About

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.

Full 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.

Enrollment

163 patients

Sex

All

Ages

3 to 10 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

163 participants in 2 patient groups

International Dental Federation
Experimental group
Description:
Dental Treatment: according to the decision based on the International Dental Federation (FDI) criteria
Treatment:
Procedure: Dental treatment
Caries Around Restorations System
Experimental group
Description:
Dental Treatment: according to the decision based on the Caries Around Restorations System (CARS) and treatment decision proposed by the International Caries Classification and Management System (ICCMS)
Treatment:
Procedure: Dental treatment

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems