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

Federal University of Pelotas

Status: Enrolling

Conditions: Caries,Dental

Treatments: Diagnostic Test: ICCMS

Study type: Interventional

Funder types: Other

Identifiers

NCT03969628

PPGO 0030

Details and patient eligibility

About

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.

Enrollment: 250 estimated patients

Sex: All

Ages: 7 to 11 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

250 participants in 2 patient groups

Multivariate risk assessment group (ICCMS®)

Experimental group

Description:

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

Treatment:

Diagnostic Test: ICCMS

Simplified risk assessment group (dental caries experience)

Experimental group

Description:

Simplified risk assessment group (dental caries experience): simplified caries risk assessment based on dental caries experience (WHO criteria)

Treatment:

Diagnostic Test: ICCMS