Dental Anxiety
Conditions
Interventions
This is a two-arm, double-blind, randomized controlled clinical trial. Experimental group: 30 children will receive Melatonin solution 0.75mg/kg orally. Control group: 30 children will receive placebo
D26.660
Sponsors
Centro Universitário CESMAC
Centro Universitário CESMAC
Eligibility
Age
3 Years to 10 Years
Inclusion criteria
Inclusion criteria: Children aged between 3 and 10 years; of both sexes; with physical status according to American Society of Anesthesiology (ASA) I and II; scheduled for dental care at Clinical School of Dentistry of the Centro Universitário Cesmac, PAM Salgadinho and Nutritional Recovery and Education Center
Exclusion criteria
Exclusion criteria: Children with mental disorders and disabilities that difficult them to understand commands; children have previously used anxiolytic and/or antipsychotic medications
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the effect of Melatonin on anxiety before pediatric dental care, by comparing dental anxiety behavior and hemodynamic parameters (heart rate) in the pre-dental care and after intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the occurrence of adverse effects with the use of Melatonin ;Assess parent/guardian and professionals satisfaction | — |
Countries
Brazil
Contacts
Public ContactIsabele Pureza
Centro Universitário CESMAC
Outcome results
None listed