Skip to main content
OpenTrials
Completed

NCT Number: NCT07162272

The Efficacy of Melatonin Patches on Dental Anxiety in Children

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Dental Anxiety Children

Age range

5 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

Cairo, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

Melatonin Patches

Drug

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 names: Melatonin Stickers

Placebo Group

Other

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.

Other names: Non-melatonin patches, melatonin-free patches

Primary outcomes

  1. Modified Child Dental Anxiety Scale

    Time frame: 1 day: from recruitment to end of treatment 1 day.

    The child's anxiety will be measured using the five faces version of the modified child dental anxiety scale (MCDAS). It contains five-point Likert scale each corresponding to a smiley face that describe one of the feelings ranging from "relaxed/not worried" (1) to "very worried" (5). This will be recorded at baseline (pre-intervention), 30 minutes after melatonin patch placement (peri-operatively phase I), then immediately after local anesthesia injection (peri-operatively phase II), and immediately post-operatively.

  2. Blood Pressure

    Time frame: 1 day: from recruitment to end of treatment 1 day.

    Measuring patients' systolic and diastolic blood pressure using a digital blood pressure scale. This will be recorded at baseline (pre-intervention), 30 minutes after melatonin patch placement (peri-operatively phase I), then immediately after local anesthesia injection (peri-operatively phase II), and immediately post-operatively.

  3. Pulse rate

    Time frame: 1 day: from recruitment to end of treatment 1 day.

    Measuring patients' pulse rate using digital pulse oximeter scale. This will be recorded at baseline (pre-intervention), 30 minutes after melatonin patch placement (peri-operatively phase I), then immediately after local anesthesia injection (peri-operatively phase II), and immediately post-operatively.

  4. Oxygen Saturation

    Time frame: 1 day: from recruitment to end of treatment 1 day.

    Measuring patients' oxygen saturation using digital pulse oximeter scale. This will be recorded at baseline (pre-intervention), 30 minutes after melatonin patch placement (peri-operatively phase I), then immediately after local anesthesia injection (peri-operatively phase II), and immediately post-operatively.

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Sep 9, 2025
Registry last updated
Nov 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.