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NCT Number: NCT03969628

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

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.

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Key information

Age range

7 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Graduate Program in Dentistry

Pelotas, Rio Grande do Sul, 96015080, Brazil

Location status: Recruiting

Location contact

Aryane M Menegaz, PhD

SUB_INVESTIGATOR

Fausto M Mendes, PhD

SUB_INVESTIGATOR

Mariana M Fraga, PhD

SUB_INVESTIGATOR

Marina S Azevedo, PhD

PRINCIPAL_INVESTIGATOR

Maximiliano S Cenci, PhD

CONTACT

[email protected]

555332606741

Thays V Oliveira, MSc

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ICCMS

Diagnostic Test

Risk caries assessment will consider ICCMS criteria

Primary outcomes

  1. New caries lesions

    Time frame: from baseline (first measurement) to 24months

    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 outcomes

  1. Quality of life score

    Time frame: from baseline (first measurement) to 24months

    Impact on oral health related quality of life measured by a validated questionnaire (CPQ)

Study contacts

Contact information is provided by the study sponsor or research team.

Marina S Azevedo, PhD

CONTACT

[email protected]

555332602830

Sponsors and collaborators

Lead sponsor

Federal University of Pelotas

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2025
Study completion
2028
First posted
May 31, 2019
Registry last updated
Apr 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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