Sedation Versus Protective Stabilization for Pediatric Dental Treatment
Status:
Recruiting
Trial end date:
2023-12-31
Target enrollment:
Participant gender:
Summary
There is a lack of evidence on the effectiveness of moderate sedation in pediatric dentistry,
compared to protective stabilization, which remains routinely used in the Brazilian context
despite moral questions. The objective of this prospective nonrandomized clinical trial is to
evaluate the effectiveness of the use of moderate sedation, compared to the protective
stabilization, in the dental care of children with fear / anxiety and / or dental behavior
problem, and associated factors. The study will be carried out in outpatient clinics of the
Dental Schools of the Federal University of Goiás (UFG) and University of São Paulo (USP),
with the support of professors from King's College London through the partnership CEDACORE -
Children Experiencing Dental Anxiety: Collaboration on Research and Education. Participants
will be 152 children under 7 years of age with dental caries, who need specialized dental
treatment due to a history of non-cooperation with dental care. The interventions to be
compared are moderate sedation with oral administration of ketamine and midazolam (UFG) and
protective stabilization (USP). The primary endpoint 'behavior / anxiety of the child during
treatment will be assessed using the Ohio State University Behavioral Rating Scale. The
secondary outcomes are: dental behavioral and anxiety evolution of the child, child' pain
during procedure, impact on the quality of life related to oral health, parents and dentists'
satisfaction and stress, adverse events for sedated participants, longevity of composite and
glass ionomer cement restorations, chronotype and physiological stress of these children. A
cost-efficacy analysis will be produced at the end of the study from the perspective of the
Sistema Único de Saúde. Additionally, at the end of 36 months, the investigators expect to
contribute to the identification of psychosocial aspects related to dental behavior problems
in children in early childhood. It is important to highlight the perspective of technological
innovation, with the creation of a digital platform that will allow the registration of data
related to the dental care of children worldwide and favor analyzes in the methodology of
data science.