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Sedation Versus Protective Stabilization for Pediatric Dental Treatment

RecruitingPhase 4Ages 1 Year - 7 YearsAllUniversidade Federal de Goias
NCT04119180 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 spe

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📋 Eligibility rules (as published)
Inclusion Criteria: * Children presenting cavities that need dental restoration * ASA I (healthy) or II (mild and controlled systemic disease - persistent asthma, for example) children (ASA, 2015) * Medical history without neurological or cognitive impairment * Children who do not use medicines that may impair cognitive functions * Children at low risk for airway obstruction (Mallampati less than 2 and / or tonsil hypertrophy occupying less than 50% of the oropharynx) (Mallampati et al., 1985) Exclusion Criteria: * Children with positive or definitely positive behavior (Frankl et al. 1962) in the dental examination session * Non-attendance at the first intervention appointment after three scheduling attempts * Chronic use of systemic corticosteroids
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What it tests

  • Ketamine 50 MG/ML
  • Midazolam Hcl 2Mg/Ml Syrup
  • Protective stabilization
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Where

2 sites
Dental School - UFG
Goiânia, Brazil
Dental School - FOUSP
São Paulo, Brazil
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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