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

October 14, 2021 updated by: Fausto Medeiros Mendes, University of Sao Paulo

CARies DEtection in Children 03 - The Impact of Two Different Clinical Criteria for the Evaluation of Caries Lesions Around Restorations in Primary Teeth

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

163

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Sao Paulo, Brazil, 05508-000
        • School of Dentistry, University of Sao Paulo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 10 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: International Dental Federation
Dental Treatment: according to the decision based on the International Dental Federation (FDI) criteria
Procedure: Dental treatment
Treatment of all dental restorations of the children according to the diagnosis criteria
Experimental: Caries Around Restorations System
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)
Procedure: Dental treatment
Treatment of all dental restorations of the children according to the diagnosis criteria

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Restoration survival
Time Frame: 24 months

Major failures of restorations: restorations presenting failures that need replacement or teeth with pulp involvement, pain or that need extraction (except due to orthodontic reasons). For restorations involving occlusal surfaces, score 4 of Frencken et al. criteria (1996) will be considered. For restorations involving other surfaces, the scores 21, 30, and 40.

The primary outcome was changed due to the COVID-19 pandemic situation. As we were not able to assess patients' restorations at 24 months, we could not evaluate the need for operative treatment at this time. Therefore, restoration survival was set as the primary outcome, as we can determine the restoration failure by the assessment date.
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Operative treatment needs of the evaluated restorations (success of restoration)
Time Frame: 24 months.

The necessity to repair the evaluated restorations during the follow-up examinations will be assessed by the Roeleveld et al. (1996) criteria (scores 11, 12, 13 and 30) or Frencken et al. (1996) criteria (scores 2 and 3). The criteria are described below:

Roeleveld et al. (1996): Score 11 - Restoration present, defect at the margin and/or wear of the surface; > 0.5 mm in depth, repair needed; Score 12 - Restoration present; underfilled > 0.5 mm, no gap, repair needed; Score 13 - Restoration overfilled > 0.5 mm, repair needed; Score 30 - Restoration not present, bulk fracture, loose, (partly) lost; repair needed (if still possible without exposing the pulp).

Frencken et al. (2006): Score 2 - Restoration present, marginal defect between 0.5mm and 1.0 mm, repair needed. Score 3 - Restoration present, marginal defect between > 1.0 mm, repair needed.
24 months.
Necessity to repair the restoration
Time Frame: 24 months.

The necessity to repair the evaluated restorations during the follow-up examinations will be assessed by the Roeleveld et al. (1996) criteria (scores 11, 12, 13 and 30) or Frencken et al. (1996) criteria (scores 2 and 3). The criteria of the respective scores are described below:

Roeleveld et al. (1996) Score 11 - Restoration present, defect at the margin and/or wear of the surface; > 0.5 mm in depth, repair needed. Score 12 - Restoration present; underfilled > 0.5 mm, no gap, repair needed. Score 13 - Restoration overfilled > 0.5 mm, repair needed. Score 30 - Restoration not present, bulk fracture, loose, (partly) lost; repair needed (if still possible without exposing the pulp). Frencken et al. (2006) Score 2 - Restoration present, marginal defect between 0.5mm and 1.0 mm, repair needed. Score 3 - Restoration present, marginal defect between > 1.0 mm, repair needed.
24 months.
Restoration replacement
Time Frame: 24 months.
Necessity of restoration replacement due to restoration loss (total or partial), with no signs of pulp involvement. For restorations involving occlusal surfaces, score 4 of Frencken et al. criteria (1996) will be considered. For restorations involving other surfaces, the scores 21, and 30.
24 months.
Presence of secondary caries lesion with dentin exposure
Time Frame: 24 months.

Caries lesion with dentin exposure around evaluated restorations detected in the follow-up examinations will be assessed by the Roeleveld et al. criteria (scores 20 and 21). The criteria of the respective scores are described below:

Score 20 - Secondary caries, discoloration in depth, surface hard and intact, caries within dentin; repair needed. Score 21 - Secondary caries. Surface defect, caries within dentin; repair needed. Frencken criteria system does not deal with this aspect. Therefore, we considered the same parameters described above
24 months.
Restored teeth that presents symptoms of pulp inflammation or episode of pain
Time Frame: 24 months.

The restored teeth that presents symptoms of pulp inflammation or episode of pain during the follow-up examinations and need to be extracted will be assessed by the Roeleveld et al. criteria (score 40) for all types of restorations. The criteria of the respective score is described below:

Score 40 - Inflammation of the pulp (restoration still in situ, not categorized in the former categories); fistula or severe pain complaints; extraction needed.
24 months.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact of Oral Health on quality of life
Time Frame: 24 months
Impact of Oral Health on quality of life of the children participants in the study will be assessed through the questionnaire "Early Childhood Oral Health Impact Scale" (ECOHIS). The questionnaire is answered by the parents and contains 13 questions, divided into two sections: a child impact section with 4 domains (child symptoms, function, psychological, and self-image/social interaction domains) and a family impact section with 2 domains (parental distress and family function). Respondents answer the questions using a rating scale from 0 to 5, and total scores can range from 0 to 52. Score r corresponds to the "don't know" answer. Higher ECOHIS scores are indicative of greater negative impacts of oral health problems on quality of life. The questionnaire will be applied at the baseline and after 24 months of follow-up, preferentially to the same parent who responded the first questionnaire.
24 months
Cost of the treatments
Time Frame: 24 months
The cost of the treatments performed during the follow-up per child considering the teeth included in our sample.
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Collaborators

Conselho Nacional de Desenvolvimento Científico e Tecnológico

Investigators

  • Principal Investigator: Fausto M Mendes, PhD, School of Dentistry, University of Sao Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 16, 2017

Primary Completion (Actual)

November 30, 2018

Study Completion (Actual)

September 15, 2021

Study Registration Dates

First Submitted

March 6, 2018

First Submitted That Met QC Criteria

April 26, 2018

First Posted (Actual)

May 9, 2018

Study Record Updates

Last Update Posted (Actual)

October 20, 2021

Last Update Submitted That Met QC Criteria

October 14, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CARDEC-03

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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