Comparing sedation methods for children's dental treatment
Sedation Versus Protective Stabilization for Dental Treatment of Children With Caries and Negative Behavior at the Dentist: a Non-randomized Clinical Trial
This study is testing whether using medication or physical restraint is better for helping young children with dental anxiety get the dental care they need.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 152 (estimated) |
| Ages | 1 Year to 7 Years |
| Sex | All |
| Sponsor | Universidade Federal de Goias Academic / other |
| Locations | 2 sites (Goiânia, Goiás and 1 other locations) |
| Trial ID | NCT04119180 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of moderate sedation versus protective stabilization in treating children with dental anxiety and behavior issues. It involves 152 children under 7 years old who require dental restoration due to cavities and have a history of non-cooperation. The study is conducted in outpatient clinics at the Federal University of Goiás and the University of São Paulo, with collaboration from King's College London. The interventions include the administration of ketamine and midazolam for sedation, compared to physical restraint methods.
Who should consider this trial
Good fit: Ideal candidates are children under 7 years old with dental caries and a history of non-cooperation during dental care.
Not a fit: Patients who exhibit positive behavior during dental examinations may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve dental treatment experiences for anxious children, leading to better oral health outcomes.
How similar studies have performed: Previous studies have explored sedation in pediatric dentistry, but this specific comparison of sedation versus stabilization is less common, making it a novel approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Goiânia, Goiás and 1 other locations
- Dental School - UFG — Goiânia, Goiás, Brazil (Active_not_recruiting)
- Dental School - FOUSP — São Paulo, São Paulo, Brazil (Recruiting)
Study contacts
- Principal investigator: Luciane RS Costa, PhD — Universidade Federal de Goias
- Study coordinator: Patricia C Faria, PhD
- Email: patriciacorreafaria@ufg.br
- Phone: 6232096325
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.