Status:

COMPLETED

The Efficacy of Melatonin Patches on Dental Anxiety in Children

Lead Sponsor:

Ain Shams University

Conditions:

Dental Anxiety

Children

Eligibility:

All Genders

5-7 years

Phase:

PHASE4

Brief Summary

Statement of Problem: Dental anxiety significantly impacts dental treatment outcomes, particularly in pediatric patients. Given the side effects associated with current oral anxiolytic medications, t...

Eligibility Criteria

Inclusion

  • Healthy children aged 5-7 years old.
  • Patients exhibiting Frankl's behavior rating grade III or IV.
  • Children requiring invasive dental treatment in their primary teeth.

Exclusion

  • Patients with severe dental symptoms (e.g. spontaneous pain, pain not relieved by analgesics).
  • History of allergy to melatonin
  • Children who currently use any medication
  • Orphans and special health care needs patient.

Key Trial Info

Start Date :

June 25 2025

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

August 29 2025

Estimated Enrollment :

52 Patients enrolled

Trial Details

Trial ID

NCT07162272

Start Date

June 25 2025

End Date

August 29 2025

Last Update

November 13 2025

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Outpatient clinic of pediatric dentistry department faculty of Dentistry Ain Shams University

Cairo, Egypt