Efficacy of Oral Melatonin as Premedication in uncooperative patients: A Clinical Study
Trial Snapshot
- Phase
- Phase 4
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 81
- Locations
- 1
Study Overview
Brief Summary
This study aims to evaluate the efficacy and safety of oral melatonin as a sedative agent in pediatric dental patients aged 3–12 years. The primary objective is to assess the sedation success rate and anxiety reduction during dental procedures, using standardized behavioral and sedation scales. Secondary objectives include evaluating child cooperation, physiological stability (heart rate, oxygen saturation, blood pressure), recovery profile, and adverse events.
Children requiring dental treatment under sedation will be randomly allocated to receive oral melatonin prior to the procedure. Sedation depth, treatment completion, and recovery will be documented. The study seeks to determine whether melatonin can serve as a safe, effective, and well-tolerated alternative to conventional sedatives in pediatric dentistry.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Masking
- None
Eligibility Criteria
- Ages
- 4.00 Year(s) to 12.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Children of age group between 3-12 years ASA I (normal, healthy) and ASA II (mild systemic illness) Frankel rating 2 and 3.
Exclusion Criteria
- •Children with a history of systemic disease Frankel rating 1 Developmental delay ASA III (a patient with a severe systemic disease) and ASA IV (a patient with a severe systemic ailment that continuously threatens life).
Investigators
Charu Aggarwal
K.D. Dental College and Hospital