The Efficacy of Melatonin Patches on Dental Anxiety in Children

NCT07162272 | Completed Phase 4 FDA Drug

• 1 other identifier: 1512
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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, 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

Keywords

Dental Anxiety; Children; Melatonin; Melatonin Patches

Outcome Measures

Primary Outcomes (4)

• Modified Child Dental Anxiety Scale

  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.

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

• Blood Pressure

  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.

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

• Pulse rate

  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.

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

• Oxygen Saturation

  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.

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

Study Arms (2)

Group1: Melatonin Patch

EXPERIMENTAL

Group 1 (n=26): Participants in the intervention group will receive two melatonin patches (each containing 1mg of melatonin, AVEELA, USA) attached to the skin of their forearm 30 minutes prior to their dental appointment according to the manufacturer's instructions. Pulse rate, blood pressure, and modified child dental anxiety scale will be measured prior to patch placement, 30minutes after their placement, after local anesthesia injection, and after completion of invasive dental treatment.

Drug: Melatonin Patches

Group 2: Placebo Group

PLACEBO COMPARATOR

Group 2 (n=26): The control group will receive two placebo stickers attached to the skin of their forearm at the same time point (30 minutes prior to the appointment). Pulse rate, blood pressure, and modified child dental anxiety scale will be measured prior to patch placement, 30minutes after their placement, after local anesthesia injection, and after completion of invasive dental treatment.

Other: Placebo Group

Interventions

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.

Also known as: Melatonin Stickers

Group1: Melatonin Patch

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.

Also known as: Non-melatonin patches, melatonin-free patches

Group 2: Placebo Group

Eligibility Criteria

• Age: 5 Years - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

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

Cairo, Egypt

Location

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Pediatric Dentistry

Study Record Dates

• First Submitted: July 29, 2025
• First Posted: September 9, 2025
• Study Start: June 25, 2025
• Primary Completion: August 28, 2025
• Study Completion: August 29, 2025
• Last Updated: November 13, 2025

Record last verified: 2025-11

Locations

EG (1)