bv-cdiResearch Supported by FAPESP
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CONSERVATIVE VERSUS NON-CONSERVATIVE TREATMENT FOR SEVERE DENTAL CARIES IN PRESCHOOL CHILDREN AND ITS IMPACT ON ORAL HEALTH-RELATED QUALITY OF LIFE, ANTHROPOMETRIC MEASURES, SPACE LOSS AND ANXIETY: RANDOMIZED CLINICAL TRIAL
This parallel-group randomized trial proposed to assess the impact of conservative (pulpectomy) versus non-conservative treatment (tooth extraction) for severe dental caries on oral health-related quality of life (OHRQoL) (primary outcome), anthropometric measures, space loss and anxiety of preschool children. The responsiveness of the Brazilian Early Childhood Oral Health Impact Scale (ECOHIS) will be also assessed. One hundred children between 3 and 5 years of age with pufa index >0 in primary molars will be selected along with their parents. Children will be randomly allocated to treatments groups (n= 48 for each group) according to the technique used: (1) pulpectomy, (2) tooth extraction. The Brazilian versions of the ECOHIS and Scale of Oral Health Outcomes for 5-year-old children (SOHO-5) will be used to assess the impact on OHRQoL comparing pre- and post-treatment by total and items scores. Anthropometric measures will be expressed as Z-scores and as conditional growth velocity for BMI-for-age, height-for-age, weight-height and weight-for-age. The extraction space or space occupied by the tooth treated with pulpectomy will be evaluated in millimetres on dental casts. Anxiety will be assessed using the Facial Image Scale before the start of the first treatment session. All the outcomes described above will be evaluated after 4, 8 and 12 months considering the allocation of the treatment groups. The responsiveness of the ECOHIS will be assessed by the magnitude of change total scores in pre- and post-treatment, and parents' global transition judgment. All analyses will be carried out on an intention-to-treat (ITT) basis and considering sensitivity analysis to assess differences between ITT and complete cases analyses.
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