The Efficacy of Melatonin Patches on Dental Anxiety in Children A Randomized Clinical Trial
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Ain Shams University
- Enrollment
- 52
- Locations
- 1
- Primary Endpoint
- Modified Child Dental Anxiety Scale
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 5 Years to 7 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Group1: Melatonin Patch
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.
Intervention: Melatonin Patches (Drug)
Group 2: Placebo Group
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.
Intervention: Placebo Group (Other)
Outcomes
Primary Outcomes
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.
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.
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.
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Nour Wahba
Lecturer of Pediatric Dentistry
Ain Shams University