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

Caries,Dental Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03969628
• Other study ID #: PPGO 0030
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2019
• Est. completion date: June 1, 2028

Study information

• Verified date: April 2023
• Source: Federal University of Pelotas
• Contact: Marina S Azevedo, PhD
• Phone: 555332602830
• Email: marinasazevedo[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: June 1, 2028
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 11 Years

Eligibility

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

Related Conditions & MeSH terms

• Caries,Dental
• Dental Caries

Intervention

Diagnostic Test:
• ICCMS
Risk caries assessment will consider ICCMS criteria

Locations

Country	Name	City	State
Brazil	Graduate Program in Dentistry	Pelotas	RS

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Pelotas

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Quality of life score	Impact on oral health related quality of life measured by a validated questionnaire (CPQ)	from baseline (first measurement) to 24months