Condition: Child Behavior · Dental Caries in Children · Sponsor: Universidade Federal de Goias
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…
This description comes directly from the study's public registry record.
Patricia C Faria, PhD · 6232096325 · patriciacorreafaria@ufg.br
Luciane R Costa, PhD · +556232096325 · lsucasas@ufg.br
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| Dental School - UFG | Goiânia, Goiás, Brazil | Active Not Recruiting |
| Dental School - FOUSP | São Paulo, São Paulo, Brazil | Recruiting |
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Source record: clinicaltrials.gov/study/NCT04119180