CARDEC-PEL: Comparison of Two Methods of Caries Risk Assessment in Children
CARies DEtection in Children-Pelotas (CARDEC-PEL): Comparison of Two Methods of Caries Risk Assessment in Children
1 other identifier
interventional
250
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 29, 2019
CompletedFirst Posted
Study publicly available on registry
May 31, 2019
CompletedStudy Start
First participant enrolled
June 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2028
ExpectedApril 25, 2023
April 1, 2023
6 years
May 29, 2019
April 24, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
New caries lesions
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 Outcomes (1)
Quality of life score
from baseline (first measurement) to 24months
Study Arms (2)
Multivariate risk assessment group (ICCMS®)
EXPERIMENTALMultivariate risk assessment group (ICCMS®): multivariate caries risk assessment based on International Caries Classification and Management System (ICCMS™) guide
Simplified risk assessment group (dental caries experience)
EXPERIMENTALSimplified risk assessment group (dental caries experience): simplified caries risk assessment based on dental caries experience (WHO criteria)
Interventions
Risk caries assessment will consider ICCMS criteria
Eligibility Criteria
You may qualify if:
- Individuals aged 7 years months to 11 years;
- Children seeking dental treatment at the Pediatric dentistry university clinic in Pelotas (UFPel)
You may not qualify if:
- Medical and/or behavioral conditions that requires special considerations regarding management/treatment of the child
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Graduate Program in Dentistry
Pelotas, Rio Grande do Sul, 96015080, Brazil
Related Publications (1)
Menegaz AM, Oliveira TTDV, Braga MM, Raggio DP, Cenci MS, Mendes FM, Azevedo MS. Randomized clinical trial to evaluate two methods of caries risk assessment in schoolchildren: the CARDEC-PEL 04 study protocol. BMC Oral Health. 2021 Dec 18;21(1):654. doi: 10.1186/s12903-021-02010-3.
PMID: 34922527DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 29, 2019
First Posted
May 31, 2019
Study Start
June 1, 2019
Primary Completion
June 1, 2025
Study Completion (Estimated)
June 1, 2028
Last Updated
April 25, 2023
Record last verified: 2023-04
Data Sharing
- IPD Sharing
- Will not share