Comparison of the Effect of Oral Melatonin Premedication on Sedation and Anxiety in Children of Different Age Groups Undergoing Pediatric Dental Procedures

Efficacy of Oral Melatonin as Premedication in uncooperative patients: A Clinical Study - MEL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/12/099962

Enrollment

Registered

2025-12-29

Start date

Unknown

Completion date

Unknown

Last updated

2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Melatonin: Oral melatonin administered as a single premedication dose prior to pediatric dental treatment. The dosage will be calculated using Young s formula, in the range of 0.25 to 0

Eligibility

Inclusion criteria

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

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)

Design outcomes

Primary

Measure	Time frame
SEATION EFFICACY ANXIOLYSISTimepoint: 3 MONTHS	—

Secondary

Measure	Time frame
- Behavioral cooperation - Physiological parameters - Recovery profile - Postoperative effects Timepoint: 3 MONTHS	—

Countries

India

Contacts

Public ContactSonal Gupta

sonalpedo@gmail.com9690440001

Outcome results