CARDEC-PEL: Comparison of Two Methods of Caries Risk Assessment in Children
Primary Purpose
Caries,Dental
Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
ICCMS
Sponsored by
About this trial
This is an interventional prevention trial for Caries,Dental
Eligibility Criteria
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
Sites / Locations
- Graduate Program in DentistryRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Multivariate risk assessment group (ICCMS®)
Simplified risk assessment group (dental caries experience)
Arm Description
Multivariate 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): simplified caries risk assessment based on dental caries experience (WHO criteria)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Quality of life score
Impact on oral health related quality of life measured by a validated questionnaire (CPQ)
Full Information
NCT ID
NCT03969628
First Posted
May 29, 2019
Last Updated
April 24, 2023
Sponsor
Federal University of Pelotas
1. Study Identification
Unique Protocol Identification Number
NCT03969628
Brief Title
CARDEC-PEL: Comparison of Two Methods of Caries Risk Assessment in Children
Official Title
CARies DEtection in Children-Pelotas (CARDEC-PEL): Comparison of Two Methods of Caries Risk Assessment in Children
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2019 (Actual)
Primary Completion Date
June 1, 2025 (Anticipated)
Study Completion Date
June 1, 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Pelotas
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Caries,Dental
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
250 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Multivariate risk assessment group (ICCMS®)
Arm Type
Experimental
Arm Description
Multivariate risk assessment group (ICCMS®): multivariate caries risk assessment based on International Caries Classification and Management System (ICCMS™) guide
Arm Title
Simplified risk assessment group (dental caries experience)
Arm Type
Experimental
Arm Description
Simplified risk assessment group (dental caries experience): simplified caries risk assessment based on dental caries experience (WHO criteria)
Intervention Type
Diagnostic Test
Intervention Name(s)
ICCMS
Intervention Description
Risk caries assessment will consider ICCMS criteria
Primary Outcome Measure Information:
Title
New caries lesions
Description
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.
Time Frame
from baseline (first measurement) to 24months
Secondary Outcome Measure Information:
Title
Quality of life score
Description
Impact on oral health related quality of life measured by a validated questionnaire (CPQ)
Time Frame
from baseline (first measurement) to 24months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marina S Azevedo, PhD
Phone
555332602830
Email
marinasazevedo@gmail.com
Facility Information:
Facility Name
Graduate Program in Dentistry
City
Pelotas
State/Province
RS
ZIP/Postal Code
96015080
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maximiliano S Cenci, PhD
Phone
555332606741
Email
cencims@gmail.com
First Name & Middle Initial & Last Name & Degree
Fausto M Mendes, PhD
First Name & Middle Initial & Last Name & Degree
Marina S Azevedo, PhD
First Name & Middle Initial & Last Name & Degree
Mariana M Fraga, PhD
First Name & Middle Initial & Last Name & Degree
Aryane M Menegaz, PhD
First Name & Middle Initial & Last Name & Degree
Thays V Oliveira, MSc
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34922527
Citation
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.
Results Reference
derived
Learn more about this trial
CARDEC-PEL: Comparison of Two Methods of Caries Risk Assessment in Children
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