Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03520309
Recruitment Status : Suspended (Follow-ups paused temporarily since March 16th due to COVID-19)
First Posted : May 9, 2018
Last Update Posted : May 28, 2020
Sponsor:
Collaborator:
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Information provided by (Responsible Party):
Fausto Medeiros Mendes, University of Sao Paulo

Tracking Information
First Submitted Date  ICMJE March 6, 2018
First Posted Date  ICMJE May 9, 2018
Last Update Posted Date May 28, 2020
Actual Study Start Date  ICMJE November 16, 2017
Actual Primary Completion Date November 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 8, 2018)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 26, 2018)
Operative treatment needs of the evaluated restorations [ Time Frame: 24 months ]
The primary outcome of this study is the necessity of operatory intervention during the follow-up of the restorations evaluated by the different criteria. This outcome is composed of several componentes and it will be assessed by the Roeleveld et al. criteria: the necessity to repair the restoration (scores 11, 12, 13 and 30); the presence of secondary caries lesion with dentin exposure (scores 20 and 21); the restored teeth that presents symptoms of pulp inflammation or episode of pain and need extraction (score 40). Each one of these events will be separately analyzed as a secondary outcome. Following on the Roeleveld et al. criteria, it will be considered "success" only the restorations that receive the scores 00 and 10. The scores 11 to 40 will be considered "failure". The scores 50, 60, 70 and 90 will not be assessed in the analysis of the success of the restoration.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 8, 2018)
  • 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.
  • 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.
  • 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.
  • 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
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 26, 2018)
  • 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. criteria (scores 11, 12, 13 and 30). The criteria of the respective scores are described below: 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).
  • 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.
  • The 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). 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.
Current Other Pre-specified Outcome Measures
 (submitted: May 9, 2018)
  • 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.
  • 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.
Original Other Pre-specified Outcome Measures
 (submitted: April 26, 2018)
  • 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 measured by a validated questionnaire (ECOHIS).
  • 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.
 
Descriptive Information
Brief Title  ICMJE Clinical Criteria for the Evaluation of Caries Lesions Around Restorations in Primary Teeth (CARDEC-03)
Official Title  ICMJE CARies DEtection in Children 03 - The Impact of Two Different Clinical Criteria for the Evaluation of Caries Lesions Around Restorations in Primary Teeth
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Dental Caries
  • Secondary Dental Caries
Intervention  ICMJE Procedure: Dental treatment
Treatment of all dental restorations of the children according to the diagnosis criteria
Study Arms  ICMJE
  • Experimental: International Dental Federation
    Dental Treatment: according to the decision based on the International Dental Federation (FDI) criteria
    Intervention: Procedure: Dental treatment
  • 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)
    Intervention: Procedure: Dental treatment
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Actual Enrollment  ICMJE
 (submitted: April 15, 2020)
163
Original Estimated Enrollment  ICMJE
 (submitted: April 26, 2018)
204
Estimated Study Completion Date  ICMJE February 2021
Actual Primary Completion Date November 30, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Years to 10 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03520309
Other Study ID Numbers  ICMJE CARDEC-03
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Fausto Medeiros Mendes, University of Sao Paulo
Study Sponsor  ICMJE University of Sao Paulo
Collaborators  ICMJE Conselho Nacional de Desenvolvimento Científico e Tecnológico
Investigators  ICMJE
Principal Investigator: Fausto M Mendes, PhD School of Dentistry, University of Sao Paulo
PRS Account University of Sao Paulo
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP