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Search / Trial NCT04119180

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

Dental Anxiety Dental Caries Conscious Sedation Physical Restraint Cost Efficacy Analysis

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.

Locations

Goiania, Goias, Brazil

São Paulo, Sp, Brazil

Patients applied

0 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

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