Clinical trial NCT02473107: Impact of Detecting Initial and Active Caries Lesions in Primary Teeth
Official title: CARies DEtection in Children - Cost-efficacy, Applicability and Impact on Quality of Life of Detecting Active Initial Caries Lesions in Primary Teeth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Caries
Keywords: Dental caries
Primary tooth
Caries Detection
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
name: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
First posted: 2015-06-16
Enrollment: 260
Sex: ALL
Minimum age (years): 36
Maximum age (years): 83
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Incremental number of dental surfaces with operative treatment needs
timeFrame: After 12 and 24 months from allocation
Secondary outcomes:
measure: Cost-efficacy
timeFrame: After 12 and 24 months from the allocation
measure: Discomfort
timeFrame: immediately after the allocation and after 12 and 24 months
measure: Impact of oral health on quality of life
timeFrame: 12 and 24 months after the allocation
Other outcomes:
measure: Costs
timeFrame: Immediately after allocation
Locations:
city: Sao Paulo
country: Brazil
facility: University of Sao Paulo
Study officials:
affiliation: University of Sao Paulo
name: Mariana M Braga
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Sao Paulo
name: Isabela Floriano
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Sao Paulo
name: Fausto M Mendes
role: PRINCIPAL_INVESTIGATOR
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