Dental Caries
Conditions
Keywords
Dental caries, Primary tooth, Caries Detection
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.
Interventions
OTHERAdvanced caries lesions detection (no activity assessment)
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.
OTHERAll caries lesions detection (+activity assessment)
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.
Sponsors
Fundação de Amparo à Pesquisa do Estado de São Paulo
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
University of Sao Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
36 Months to 83 Months
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incremental number of dental surfaces with operative treatment needs | After 12 and 24 months from allocation | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cost-efficacy | After 12 and 24 months from the allocation | 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. |
| Discomfort | immediately after the allocation and after 12 and 24 months | Participants' discomfort, measured by a validated scale (Wong-Baker scale). |
| Impact of oral health on quality of life | 12 and 24 months after the allocation | Impact of oral health on quality of life of the children participants in the study, measured by a validated questionnaire (ECOHIS). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Costs | Immediately after allocation | The costs of each diagnostic strategy and treatment based on that will be calculated, regarding time of each clinical session, materials used, duration of treatment and possible repetitions. |
Countries
Brazil
Outcome results
None listed