NCT04119180

Sedation Versus Protective Stabilization for Pediatric Dental Treatment

Recruiting now Phase 4 Last updated 10 December 2024

What this trial tests

Phase 4 trial testing Ketamine 50 MG/ML in Child Behavior in 152 participants. Currently enrolling.

Timeline

30 January 2020

Primary endpoint
28 February 2025

28 February 2026

Quick facts

Lead sponsor	Universidade Federal de Goias
Phase	Phase 4
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	152
Start date	30 January 2020
Primary completion	28 February 2025
Estimated completion	28 February 2026
Sites	2 locations across Brazil

Drugs / interventions tested

• Ketamine 50 MG/ML — full drug profile →
• Midazolam Hcl 2Mg/Ml Syrup
• Protective stabilization

Conditions studied

• Child Behavior — all drugs for Child Behavior →
• Dental Caries in Children — all drugs for Dental Caries in Children →

Sponsor

Universidade Federal de Goias — full company profile →

Who can join

Adults 1 to 7, any sex, with Child Behavior or Dental Caries in Children. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Sedation versus protective stabilization for dental treatment of children with caries and challenging behavior at the dentist (CHOOSE): a study protocol for a non-randomized clinical trial.
   da Silva GS, Anabuki AA, Viana KA, Corrêa-Faria P, et al · · 2021 · cited 5× · PMID 33980232 · DOI 10.1186/s12903-021-01594-0