Sedation Versus Protective Stabilization for Pediatric Dental Treatment

Recruiting now · Phase 4

Conditions studied: Child Behavior, Dental Caries in Children

In brief

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.

Key facts

Study ID

NCT04119180

Run by

Universidade Federal de Goias

People needed

152

Starts

2020-01-30

Expected to finish

2026-02-28

Last updated by the study team

2024-12-10

Who can join

Age: 1 and older, up to 7. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Dental School - FOUSP — São Paulo, São Paulo, Brazil (enrolling)
• Dental School - UFG — Goiânia, Goiás, Brazil

Full record on ClinicalTrials.gov

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