Abstract
BackgroundThere 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.MethodsParticipants 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).DiscussionConsidering 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
Highlights
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
The other indicated no studies that allowed comparing the efficacy of sedation versus general anesthesia for dental treatment to children and adolescents under 18 years of age [7]
This theme is essential for developing pediatric practice in Brazil and has a global impact since protective stabilization is still considered necessary for many countries
Summary
Trial design According to the guideline Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT), the present protocol was reported, as detailed in Additional file 1. The secondary outcomes are related to children’s, families, and dentists’ reports and other objective measures from the dental care (Table 1) Selected observers from both sites will be trained to assess children’s behavior (OSUBRS) and pain/distress (FLACC) by collectively discussing the theory behind each tool and applying the scales to 10 videos from similar participants undergoing dental treatment recorded for previous studies. Adverse events (sedation group) or unfavorable restraint signs (protective stabilization) will be described In this stage, the control of missing data is not foreseen because if a participant does not attend the first intervention consultation, she/he will be excluded from the study. The incremental cost-effectiveness ratio (ICER) will be calculated by dividing the mean difference in the cost of sedation of a child compared to the protective stabilization due to the difference in the median probability of success between the two groups
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