The Efficacy of Melatonin Patches on Dental Anxiety in Children

Ain Shams University

Status and phase: Completed; Phase 4

Conditions: Dental Anxiety; Children

Treatments: Drug: Melatonin Patches; Other: Placebo Group

Study type: Interventional

Funder types: Other

Identifiers

NCT07162272

1512

Details and patient eligibility

About

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.

Enrollment: 52 patients

Sex: All

Ages: 5 to 7 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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52 participants in 2 patient groups, including a placebo group

Group1: Melatonin Patch

Experimental group

Description:

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.

Treatment:

Drug: Melatonin Patches

Group 2: Placebo Group

Placebo Comparator group

Description:

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.

Treatment:

Other: Placebo Group