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

NCT ID: NCT03969628

Last Updated: 2023-04-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-01
• Study Completion Date: 2028-06-01

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.

Conditions

Caries,Dental

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Multivariate risk assessment group (ICCMS®)

Multivariate risk assessment group (ICCMS®): multivariate caries risk assessment based on International Caries Classification and Management System (ICCMS™) guide

Group Type: EXPERIMENTAL

ICCMS

Intervention Type: DIAGNOSTIC_TEST

Risk caries assessment will consider ICCMS criteria

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)

Group Type: EXPERIMENTAL

ICCMS

Intervention Type: DIAGNOSTIC_TEST

Risk caries assessment will consider ICCMS criteria

Interventions

ICCMS

Risk caries assessment will consider ICCMS criteria

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 11 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Federal University of Pelotas

OTHER

Sponsor Role: lead

Responsible Party

Maximiliano Sergio Cenci

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Graduate Program in Dentistry

Pelotas, Rio Grande do Sul, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Marina S Azevedo, PhD

Role: CONTACT

marinasazevedo@gmail.com

555332602830

Facility Contacts

Maximiliano S Cenci, PhD

Role: primary

cencims@gmail.com

555332606741

References

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.

Reference Type: DERIVED

PMID: 34922527 (View on PubMed)

Other Identifiers

PPGO 0030

Identifier Type: -

Identifier Source: org_study_id