CARDEC-PEL: Comparison of Two Methods of Caries Risk Assessment in Children

April 24, 2023 updated by: Maximiliano Sergio Cenci, Federal University of Pelotas

CARies DEtection in Children-Pelotas (CARDEC-PEL): Comparison of Two Methods of Caries Risk Assessment in Children

The aim of the study was to compare dental caries treatment and follow-up based on an elaborate and individualized assessment of caries risk in children, to a simpler risk assessment strategy by means of a double-blind randomized clinical trial of two years monitoring. Participants will be children from 7 to 11 years old, who pass through the screening of the Children's Clinic of the Faculty of Dentistry of the Federal University of Pelotas and fulfill the inclusion criteria. A randomized, stratified sample of approximately 250 children will be included in the study, one group will be composed of children undergoing dental caries-related treatment and maintenance, guided by an individualized and multivariate risk assessment, and another group of children treated based on dental caries experience alone in the deciduous and / or permanent dentition. Recruitment will begin at the beginning of 2019, and participants will be followed up for 24 months. Parents will respond to an anamnesis, 24-hour dietary recall, food frequency questionnaire, and oral and general health-related quality of life questionnaire, children will undergo a clinical examination to assess caries, according to the International Caries Detection and Assessment System (ICDAS) in its simplified form and evaluation of caries activity. Dental treatments and return intervals will be designated according to the individual risk of the patient detected in the initial approach according to the group. The study evaluations consist of baseline, 12 months and 24 months, data will be transferred to spreadsheets after the different phases of the study. Primary outcomes (number of dental surfaces requiring operative intervention) and secondary outcomes will be analyzed by Student's t test, quality of life and quality of life related to oral health, will be assessed at the beginning of the study and at the end of treatment, and compared between the groups.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

250

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 Contact

Study Locations

  • Brazil
    • RS
      • Pelotas, RS, Brazil, 96015080
        • Recruiting
        • Graduate Program in Dentistry
        • Contact:
        • Sub-Investigator:
          • Fausto M Mendes, PhD
        • Principal Investigator:
          • Marina S Azevedo, PhD
        • Sub-Investigator:
          • Mariana M Fraga, PhD
        • Sub-Investigator:
          • Aryane M Menegaz, PhD
        • Sub-Investigator:
          • Thays V Oliveira, MSc

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

7 years to 11 years (Child)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Individuals aged 7 years months to 11 years;
  • Children seeking dental treatment at the Pediatric dentistry university clinic in Pelotas (UFPel)

Exclusion Criteria:

  • Medical and/or behavioral conditions that requires special considerations regarding management/treatment of the child

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Multivariate risk assessment group (ICCMS®)
Multivariate risk assessment group (ICCMS®): multivariate caries risk assessment based on International Caries Classification and Management System (ICCMS™) guide
Diagnostic test: ICCMS
Risk caries assessment will consider ICCMS criteria
Experimental: Simplified risk assessment group (dental caries experience)
Simplified risk assessment group (dental caries experience): simplified caries risk assessment based on dental caries experience (WHO criteria)
Diagnostic test: ICCMS
Risk caries assessment will consider ICCMS criteria

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
New caries lesions
Time Frame: from baseline (first measurement) to 24months
Incremental number of dental surfaces with operative treatment needs. This outcome will be assessed by the new caries lesions and / or progression of lesions previously diagnosed / treated and number of treated surfaces which will need restoration replacement, endodontic treatment or extraction after the treatment plan.
from baseline (first measurement) to 24months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life score
Time Frame: from baseline (first measurement) to 24months
Impact on oral health related quality of life measured by a validated questionnaire (CPQ)
from baseline (first measurement) to 24months

Collaborators and Investigators

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

Sponsor

Federal University of Pelotas

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)

June 1, 2019

Primary Completion (Anticipated)

June 1, 2025

Study Completion (Anticipated)

June 1, 2028

Study Registration Dates

First Submitted

May 29, 2019

First Submitted That Met QC Criteria

May 29, 2019

First Posted (Actual)

May 31, 2019

Study Record Updates

Last Update Posted (Actual)

April 25, 2023

Last Update Submitted That Met QC Criteria

April 24, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PPGO 0030

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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