Evidence map›Paper›PMID 42758406›Full record

ArticleEuropean archives of paediatric dentistry : official journal of the European Academy of Paediatric Dentistry2026

The efficacy of transdermal melatonin in dental anxiety in children: a randomised placebo-controlled clinical trial.

Nour Wahba, Basma Mahmoud Nagi, Iman Ali El-Baraky, Ahmed Kamal El-Motayam

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Article in European archives of paediatric dentistry : official journal of the European Academy of Paediatric Dentistry, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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5 · Who and what money

Authors and funding

4 authors.

Nour WahbaDepartment of Pediatric Dentistry, Ain Shams University, Cairo, Egypt. nourwahba@dent.asu.edu.eg.ORCID https://orcid.org/0000-0002-7477-9390
Basma Mahmoud NagiDepartment of Pediatric Dentistry, Ain Shams University, Cairo, Egypt.ORCID https://orcid.org/0000-0001-8649-1741
Iman Ali El-BarakyClinical Pharmacy Department, Cairo University, Giza, Egypt.
Ahmed Kamal El-MotayamPediatric Dentistry Department, Cairo University, Giza, Egypt.ORCID https://orcid.org/0009-0006-5054-5545

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeDental anxiety, a prevalent barrier to optimum dental care, frequently necessitates pharmacological intervention. Melatonin appears to be a safe anxiolytic in medical settings but remains underexplored in paediatric dental anxiety management. Our objective was to evaluate the efficacy of transdermal melatonin patches in managing dental anxiety in children undergoing invasive dental treatment.

methods52 children aged 5-7 years undergoing dental treatment requiring infiltration local anaesthesia (LA) were randomly assigned to receive either 2 mg transdermal melatonin patches (n = 26) or placebo patches (n = 26), applied to the forearm 30 min before treatment. Outcomes included physiological parameters (heart rate (HR), systolic blood pressure (SPB), diastolic blood pressure (DPB), peripheral oxygen saturation (SpO2)), and dental anxiety by self-reported Facial Image Scale (FIS). All outcomes were recorded at baseline (T1), post-administration (T2), post-LA (T3), and end of treatment (T4).

resultsTransdermal melatonin did not significantly affect either the physiological parameters or the FIS compared to placebo at any timepoint. Intragroup analysis revealed that melatonin protected against the rise in HR and DBP associated with LA injection observed in the placebo group following LA injection. ANCOVA indicated a moderate, statistically significant effect of melatonin on HR at T3 independent of baseline HR (effect size = 9%, P = 0.033, power = 58%). Melatonin induced a transient increase in SpO₂ noted post-administration (mean difference 0.96%, P = 0.019).

conclusionTransdermal melatonin patches provided modest cardioprotective effects against the haemodynamic stress of dental injections during paediatric dental procedures but did not significantly reduce self-reported dental anxiety.

Indexed as

Dental anxietyPaediatric dentistryTransdermal melatonin

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.