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To compare the effectiveness of Midazolam and Melatonin to decrease anxiety

A RANDOMIZED CLINICAL TRIAL: COMPARATIVE EVALUATION OF MELATONIN AND MIDAZOLAM AS ANXIOLYTIC DRUG FOR DENTAL PROCEDURES AMONG 5-12 YEAR OLD CHILDREN.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/11/029397
Enrollment
30
Registered
2020-11-26
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: K040- Pulpitis

Interventions

Intervention1: Melatonin: Melatonin, 0.5 mg/kg 1 hour prior tp dental procedure orally Control Intervention1: Midazolam: Midazolam, 0.5mg/kg 1 hour prior to dental procedure orally

Sponsors

Dr Palak Gupta
Lead Sponsor
Dr Shoba Fernandes
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: anxious children requiring two dental procedures

Exclusion criteria

Exclusion criteria: any systemic disease or drug allergy

Design outcomes

Primary

MeasureTime frame
melatonin is effective anxiolyticc drugTimepoint: every dental visit for 2 dental visits—

Secondary

MeasureTime frame
Melatonin is as effective as midazolamTimepoint: every dental visit for 2 dental visits—

Countries

India

Contacts

Public ContactDr Shoba Fernandes

Narsinhbhai Patel Dental College and Hospital, Sankalchand Patel University

vshobaf@gmail.com7567622346

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026