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

NCT03520309 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 163

Last updated 2021-10-20

No results posted yet for this study

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.

Conditions

  • Dental Caries
  • Secondary Dental Caries

Interventions

PROCEDURE

Dental treatment

Treatment of all dental restorations of the children according to the diagnosis criteria

Sponsors & Collaborators

  • Conselho Nacional de Desenvolvimento Científico e Tecnológico

    collaborator OTHER_GOV

  • University of Sao Paulo

    lead OTHER

Principal Investigators

  • Fausto M Mendes, PhD · School of Dentistry, University of Sao Paulo

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
10 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-11-16
Primary Completion
2018-11-30
Completion
2021-09-15

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03520309 on ClinicalTrials.gov