Sedation Versus Protective Stabilization for Pediatric Dental Treatment
Launched by UNIVERSIDADE FEDERAL DE GOIAS · Oct 4, 2019
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying two different ways to help children with dental anxiety or behavior problems receive dental treatment: moderate sedation and protective stabilization. Moderate sedation involves giving children medicine to help them relax during their dental visit, while protective stabilization keeps them safely still without sedation. The trial will include 152 children under the age of 7 who have cavities and have had trouble cooperating during previous dental visits. The goal is to see which method works better for managing the children's behavior and anxiety during treatment.
To be eligible for this study, children must be generally healthy or have mild, controlled health issues, and they should not have any neurological or cognitive impairments. Parents can expect that their child will receive either sedation or stabilization during their dental care, and researchers will closely monitor how the child behaves, feels pain, and how these treatments affect their overall quality of life. Additionally, the study aims to gather valuable data that could improve future dental care for children worldwide.
Gender
ALL
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
About Universidade Federal De Goias
The Universidade Federal de Goiás (UFG) is a prominent Brazilian higher education institution renowned for its commitment to advancing research and healthcare through innovative clinical trials. With a strong emphasis on interdisciplinary collaboration, UFG aims to enhance medical knowledge and improve patient outcomes by conducting rigorous, ethical studies across various therapeutic areas. The university fosters a research environment that combines academic excellence with community engagement, ensuring that its clinical trials not only contribute to scientific advancement but also address pressing health challenges faced by diverse populations.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Goiania, Goias, Brazil
São Paulo, Sp, Brazil
Patients applied
Trial Officials
Luciane RS Costa, PhD
Principal Investigator
Universidade Federal de Goias
Daniela P Raggio, PhD
Study Director
University of Sao Paulo
Patricia C Faria, PhD
Principal Investigator
Universidade Federal de Goias
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Similar Trials