Passiflora Incarnata for Dental Extraction Anxiety

Effect of Passiflora Incarnata on Dental Extraction Anxiety A Randomized Controlled Trial

This study looks at whether Passiflora incarnata (passionflower extract) can help reduce anxiety before tooth extraction. Male participants who feel high anxiety before the procedure will receive either passionflower extract or an inactive substance (placebo) before their extraction. Neither the participants nor the researchers will know who receives which one. The study will compare anxiety levels using a questionnaire, along with body responses such as heart rate and blood pressure. The goal is to find out whether this natural option could help patients who fear tooth extraction, without the use of medication

Dental extraction is commonly associated with significant preoperative anxiety, which can affect hemodynamic stability, pain perception, and patient cooperation during the procedure. Pharmacological approaches such as benzodiazepines are frequently used to manage this anxiety, but they carry risks of sedation, dependency, and adverse interactions, prompting interest in safer, non-pharmacological alternatives. Passiflora incarnata is a herbal extract with reported anxiolytic properties, potentially acting through 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 the context of dental procedures, most enrolled patients regardless of baseline anxiety level, potentially diluting any observable anxiolytic effect. To address this gap, the present study restricts enrollment to patients presenting with clinically significant preoperative anxiety, defined as a State-Trait Anxiety Inventory (STAI) state score of 40 or above, allowing a more sensitive assessment of the intervention's clinical impact.

This randomized, double-blind, placebo-controlled trial investigates the anxiolytic efficacy of Passiflora incarnata in male patients undergoing dental extraction. Participants are randomly allocated to receive either a single oral dose of Passiflora incarnata extract or a matching placebo prior to the procedure. Outcomes assessed include changes in state anxiety scores, hemodynamic parameters (heart rate, blood pressure), and the adverse event profile associated with the intervention.

Female participants of reproductive age were not included in this study. This decision was based on two considerations: first, insufficient clinical data regarding the safety and efficacy of Passiflora incarnata during pregnancy and lactation, which precluded routine inclusion without pregnancy screening; and second, evidence that hormonal fluctuations across the menstrual cycle, particularly during the luteal phase, may influence hypothalamic-pituitary-adrenal axis activity and state anxiety responses, introducing a potential confounding variable. Restricting the sample to male participants allowed for a more homogeneous population in which to evaluate the intervention's effect, though this limits the generalizability of the findings to female patients. Future studies incorporating female participants with controlled menstrual cycle phase are warranted

Inclusion Criteria:

Patients presenting for dental extraction at Kahramanmaraş Sütçü İmam University Faculty of Dentistry Voluntary agreement to participate and signed informed consent State-Trait Anxiety Inventory (STAI) state anxiety score of 40 or above Male sex No general health disorder based on medical history and physical examination

Exclusion Criteria:

STAI state anxiety score below 40 Refusal to voluntarily participate in the study General health disorder based on medical history and physical examination Age under 18 years Female sex Known hypersensitivity to Passiflora incarnata Use of synthetic sedatives