Comparing sedation methods for children's dental treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Dental School - FOUSP
  São Paulo, São Paulo, Brazil Recruiting
• Dental School - UFG
  Goiânia, Goiás, Brazil Active not 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.