Passiflora Incarnata for Dental Extraction Anxiety

Dental extraction is commonly associated with significant preoperative anxiety, which canaffect hemodynamic stability, pain perception, and patient cooperation during theprocedure. Pharmacological approaches such as benzodiazepines are frequently used tomanage this anxiety, but they carry risks of sedation, dependency, and adverseinteractions, prompting interest in safer, non‐pharmacological alternatives. Passifloraincarnata is a herbal extract with reported anxiolytic properties, potentially actingthrough modulation of the GABAergic system in a manner similar to, but milder than,conventional anxiolytics, with a favorable safety profile in prior clinical use.While previous randomized controlled trials have evaluated Passiflora incarnata in thecontext of dental procedures, most enrolled patients regardless of baseline anxietylevel, potentially diluting any observable anxiolytic effect. To address this gap, thepresent study restricts enrollment to patients presenting with clinically significantpreoperative anxiety, defined as a State‐Trait Anxiety Inventory (STAI) state score of 40or above, allowing a more sensitive assessment of the intervention's clinical impact.This randomized, double‐blind, placebo‐controlled trial investigates the anxiolyticefficacy of Passiflora incarnata in male patients undergoing dental extraction.Participants are randomly allocated to receive either a single oral dose of Passifloraincarnata extract or a matching placebo prior to the procedure. Outcomes assessed includechanges in state anxiety scores, hemodynamic parameters (heart rate, blood pressure), andthe adverse event profile associated with the intervention.Female participants of reproductive age were not included in this study. This decisionwas based on two considerations: first, insufficient clinical data regarding the safetyand efficacy of Passiflora incarnata during pregnancy and lactation, which precludedroutine inclusion without pregnancy screening; and second, evidence that hormonalfluctuations across the menstrual cycle, particularly during the luteal phase, mayinfluence hypothalamic‐pituitary‐adrenal axis activity and state anxiety responses,introducing a potential confounding variable. Restricting the sample to male participantsallowed for a more homogeneous population in which to evaluate the intervention's effect,though this limits the generalizability of the findings to female patients. Futurestudies incorporating female participants with controlled menstrual cycle phase arewarranted