drugset / Trial / NCT07162272

The Efficacy of Melatonin Patches on Dental Anxiety in Children

NCT07162272

Phase 4 Completed 52 enrolled Ain Shams University
RandomizedParallel-groupDouble-blindTreatment

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, there is a need to clinically evaluate safe and natural alternatives, such as melatonin patches, to validate their efficacy. Aim of Study: The aim of this study is to evaluate the effect of melatonin patches on reducing dental anxiety in children. Anxiety assessments will be done by recording the pulse rate, blood pressure, and by utilization of the modified child dental anxiety scale in pediatric dental patients. Materials and Methods: Fifty two children will be divided into two groups. One group (n=26) will be given two melatonin patches per patient and the other group (n=26) will receive two placebo stickers 30 minutes before dental treatment. Pulse rate, blood pressure and modified child dental anxiety scale will be recorded before and after dental treatment completion as well as after the intervention for both groups.

Timeline

Start
2025-06-25
Primary completion
2025-08-28
Completion
2025-08-29

Drugs

EvaluationDrugModalityDoseRoute
Subject Melatonin Small molecule 1 mg Topical

Indications

No indication recorded.