Impact of Detecting Initial and Active Caries Lesions in Primary Teeth

University of Sao Paulo

Status: Completed

Conditions: Dental Caries

Treatments: Other: Advanced caries lesions detection (no activity assessment); Other: All caries lesions detection (+activity assessment)

Study type: Interventional

Funder types: Other

Identifiers

NCT02473107

CARDEC-02

Details and patient eligibility

About

The present study aims to evaluate the impact of detecting active initial caries lesions in primary teeth regarding effectiveness, cost-effectiveness, applicability (acceptability and satisfaction) and quality of life. For this, 248 children 3-6 years with complete primary dentition will be examined and treated in a mobile dental unit, which will temporarily be parked in public schools of Sao Paulo. The caries detection will be conducted using the International Caries Detection and Assessment System (ICDAS) and, depending on allocation, an adjunct criterion for caries activity assessment. Children will be randomized in two groups according to the caries threshold to be detected: Group A (only advanced lesions will be detected and treated, independently of their activity status) and Group B (all caries lesions, including initial ones, will be detected and all active lesions will be treated). After this, the treatment plan for each child will be made according to strategies mentioned above. Data concerning the cost-effectiveness of the procedures, acceptability / satisfaction of children and quality of life will be collected after diagnosis, after the end of treatment and 12 and 24 months from the initial examination. For comparison between groups, multilevel regression analyses will be performed. The primary outcome will be sites which need of operative treatment during the follow-up periods and the secondary outcomes will be the cost-effectiveness of each strategy, the acceptability / satisfaction of the child and the impact on quality of life.

Enrollment: 260 patients

Sex: All

Ages: 36 to 83 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Individuals aged 36 months to 83 months;
• Should have complete primary dentition;
• Children must assent to participate and their parents must consent to their participation by signing the consent form.

Exclusion criteria

• Medical and/or behavioral conditions that requires special considerations regarding management/treatment of the child;
• Children involved in other research that may impact on this study;
• Families who are expected to move out of the coverage area of study during the first year of enrollment.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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260 participants in 2 patient groups

Control Caries Detection Strategy

Other group

Description:

Detection and treatment based on more advanced lesions, despite activity status - Advanced caries lesions detection (no activity assessment)

Treatment:

Other: Advanced caries lesions detection (no activity assessment)

Test Caries Detection Strategy

Other group

Description:

Detection and treatment based on all detected caries lesions, considering their activity status as a differential in clinical decision-making - All caries lesions detection (+activity assessment)

Treatment:

Other: All caries lesions detection (+activity assessment)