Status:
RECRUITING
Sedation Versus Protective Stabilization for Pediatric Dental Treatment
Lead Sponsor:
Universidade Federal de Goias
Collaborating Sponsors:
University of Sao Paulo
King's College London
Conditions:
Child Behavior
Dental Caries in Children
Eligibility:
All Genders
1-7 years
Phase:
PHASE4
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2026
Estimated Enrollment :
152 Patients enrolled
Trial Details
Trial ID
NCT04119180
Start Date
January 30 2020
End Date
February 28 2026
Last Update
December 10 2024
Active Locations (2)
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1
Dental School - UFG
Goiânia, Goiás, Brazil, 74605220
2
Dental School - FOUSP
São Paulo, São Paulo, Brazil, 05508-000