NCT07162272

The Efficacy of Melatonin Patches on Dental Anxiety in Children

The Efficacy of Melatonin Patches on Dental Anxiety in Children A Randomized Clinical Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Ain Shams University · Academic / Other
• Sex: All
• Age: 5 Years – 7 Years
• Healthy volunteers: Accepted

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.

Conditions

• Dental Anxiety
• Children

Interventions

Type	Name	Description
DRUG	Melatonin Patches	Group 1 (n=26): Participants in the intervention group will receive two melatonin patches on their forearm (each containing 1mg of melatonin, AVEELA, USA) attached to the skin of their forearm 30 minutes prior to their invasive dental treatment. Pulse Rate, Blood Pressure, and Modified Child Dental Anxiety Scale will be measured before melatonin patches application, after 30minutes of patches application, then after local anesthesia injection, and finally after completing the invasive dental treatment.
OTHER	Placebo Group	Group 2 (n=26): Participants in the intervention group will receive two placebo patches on their forearm attached to the skin of their forearm 30 minutes prior to their invasive dental treatment. Pulse Rate, Blood Pressure, and Modified Child Dental Anxiety Scale will be measured before placebo patches application, after 30minutes of patches application, then after local anesthesia injection, and finally after completing the invasive dental treatment.

Timeline

• Start date: 2025-06-25
• Primary completion: 2025-08-28
• Completion: 2025-08-29
• First posted: 2025-09-09
• Last updated: 2025-11-13

Locations

1 site across 1 country: Egypt

Regulatory

• FDA-regulated drug study