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

PURPOSE: Dental 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. METHODS: 52 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). RESULTS: Transdermal 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). CONCLUSION: Transdermal 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.