NCT04119180 Sedation Versus Protective Stabilization for Pediatric Dental Treatment
| NCT ID | NCT04119180 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Universidade Federal de Goias |
| Condition | Child Behavior |
| Study Type | INTERVENTIONAL |
| Enrollment | 152 participants |
| Start Date | 2020-01-30 |
| Primary Completion | 2025-02-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 152 participants in total. It began in 2020-01-30 with a primary completion date of 2025-02-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Luciane RS Costa, PhD
PRINCIPAL INVESTIGATOR
Universidade Federal de Goias
Frequently Asked Questions
Who can join the NCT04119180 clinical trial?
This trial is open to participants of all sexes, aged 1 Year or older, up to 7 Years, studying Child Behavior. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04119180 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT04119180 currently recruiting?
Yes, NCT04119180 is actively recruiting participants. Contact the research team at patriciacorreafaria@ufg.br for enrollment information.
Where is the NCT04119180 trial being conducted?
This trial is being conducted at Goiânia, Brazil, São Paulo, Brazil.
Who is sponsoring the NCT04119180 clinical trial?
NCT04119180 is sponsored by Universidade Federal de Goias. The principal investigator is Luciane RS Costa, PhD at Universidade Federal de Goias. The trial plans to enroll 152 participants.