Sedation versus protective stabilization for dental treatment of children with caries and challenging behavior at the dentist (CHOOSE): a study protocol for a non-randomized clinical trial.

Autor: da Silva GS; Department of Pediatric Dentistry, School of Dentistry, University of São Paulo, São Paulo, Brazil., Anabuki AA; Dentistry Graduate Program, Universidade Federal de Goias, Goiânia, GO, Brazil., Viana KA; Dentistry Graduate Program, Universidade Federal de Goias, Goiânia, GO, Brazil., Corrêa-Faria P; Dentistry Graduate Program, Universidade Federal de Goias, Goiânia, GO, Brazil., Moterane MM; Dentistry Graduate Program, Universidade Federal de Goias, Goiânia, GO, Brazil., Tedesco TK; Graduate Program in Dentistry, Ibirapuera University, São Paulo, Brazil., Costa PS; Faculty of Medicine, Universidade Federal de Goias, Goiânia, GO, Brazil., Hosey MT; Pediatric Dentistry, Centre for Oral Clinical and Translational Sciences, Faculty of Dentistry, Oral and Craniofacial Sciences, King's College London, London, UK., Raggio DP; Department of Pediatric Dentistry, School of Dentistry, University of São Paulo, São Paulo, Brazil., Costa LR; Faculty of Dentistry, Universidade Federal de Goias, Primeira Avenida, s/n, Goiânia, GO, CEP 74605-220, Brazil. lsucasas@ufg.br.
Jazyk: angličtina
Zdroj: BMC oral health [BMC Oral Health] 2021 May 12; Vol. 21 (1), pp. 256. Date of Electronic Publication: 2021 May 12.
DOI: 10.1186/s12903-021-01594-0
Abstrakt: Background: There is a lack of evidence on the effectiveness of moderate sedation in pediatric dentistry, compared to protective stabilization, which remains routinely used in Brazil despite moral questions. This prospective non-randomized clinical trial's objective is to evaluate the effectiveness of moderate sedation, compared to the protective stabilization, in the dental care of children with dental behavior management problems.
Methods: Participants will be 152 children under seven years of age with early childhood caries (ECC) who need specialized dental treatment due to a history of challenging behavior during dental care. The interventions to be compared are moderate sedation with oral administration of ketamine and midazolam and protective stabilization. The primary endpoint will be the child's behavior during treatment assessed using the Ohio State University Behavioral Rating Scale (OSUBRS). The secondary outcomes are (A) child's - behavior according to the visual analogue scale, anxiety, pain, and physiological stress; (B) parent's - satisfaction and anxiety; (C) family and child - impact on oral health-related quality of life (OHRQoL); (D) dentist's - satisfaction and stress; (E) procedure - adverse events of the intervention and dental treatment longevity. A cost-effectiveness analysis will be performed from the perspective of the Brazilian Unified Health System (SUS).
Discussion: Considering the primary outcome, this study hypothesis is that sedated children have better behavior during dental treatment than children whose behavior was managed by protective stabilization without sedation. Additionally, at the end of 12 months, we expect to identify participants' reported outcomes and objective measures related to dental behavior in early childhood. Trial registration Clinicaltrials.gov registration NCT04119180 on October 8th, 2019. https://clinicaltrials.gov/ct2/show/NCT04119180.
Databáze: MEDLINE
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