Impact of Detecting Initial and Active Caries Lesions in Primary Teeth

Study Overview
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Brief Summary
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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.

Official Title
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CARies DEtection in Children - Cost-efficacy, Applicability and Impact on Quality of Life of Detecting Active Initial Caries Lesions in Primary Teeth

Conditions
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Dental Caries

Intervention / Treatment
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* Other: Advanced caries lesions detection (no activity assessment)
* Other: All caries lesions detection (+activity assessment)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 36 Months
Maximum Age: 83 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Control Caries Detection Strategy<br>Detection and treatment based on more advanced lesions, despite activity status - Advanced caries lesions detection (no activity assessment) | Other: Advanced caries lesions detection (no activity assessment)<br>* The diagnosis strategy will based on detection of only moderate and advanced caries lesions (ICDAS scores 3 to 6). Initial caries lesions will be considered as sound surfaces. Caries activity status will not be evaluated. Clinical decision-making will be proposed for all lesions detected, based on evidence-based protocols.<br>* Other names: Extensive Decays;|
| Other: Test Caries Detection Strategy<br>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) | Other: All caries lesions detection (+activity assessment)<br>* The diagnosis strategy will based on detection of initial, moderate and advanced caries lesions (ICDAS scores 1 to 6). Caries activity status will be also evaluated. Clinical decision-making will be proposed for all active lesions detected, based on evidence-based protocols. inactive caries lesions will not be treated.<br>* Other names: early detection;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 initial treatment. | After 12 and 24 months from allocation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost-efficacy | The costs of the diagnostic strategy will be calculated and compared with threshold values for intervention cost-effectiveness by region, determined by World Health Organization. | After 12 and 24 months from the allocation | 
| Discomfort | Participants' discomfort, measured by a validated scale (Wong-Baker scale). | immediately after the allocation and after 12 and 24 months | 
| Impact of oral health on quality of life | Impact of oral health on quality of life of the children participants in the study, measured by a validated questionnaire (ECOHIS). | 12 and 24 months after the allocation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dental caries, Primary tooth, Caries Detection