Passiflora Incarnata for Dental Extraction Anxiety

ConditionsDental Anxiety Preoperative Anxiety

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexMale

Age18+

SponsorÖmer faruk Kaygısız

About this 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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

Passiflora incarnata extract
Dietary supplement
A single oral dose of Pasila (Passiflora incarnata extract, 450 mg capsule) administered prior to dental extraction.
Placebo
Other intervention
A single oral placebo capsule, identical in external appearance (color, size, and shell) to the Pasila (Passiflora incarnata extract, 450 mg) capsule, filled with brown sugar, administered prior to dental extraction.

Treatment groups

58 Participants

are divided into 2 treatment groups

Group A: Passiflora GroupExperimental treatment 1 intervention

Group B: Placebo GroupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

Change in State-Trait Anxiety Inventory (STAI) State Anxiety Score

Anxiety level assessed using the State subscale of the State-Trait Anxiety Inventory (STAI-S), with scores ranging from 20 (minimum anxiety) to 80 (maximum anxiety). Higher scores indicate greater anxiety

Time frame

Measured at three time points: 1 hour before dental extraction (baseline, before intervention), immediately before dental extraction (approximately 1 hour after intervention administration), and immediately after dental extraction (post-operative)

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ömer faruk Kaygısız

Lead sponsor

University of Gaziantep

Sponsor institution

Kahramanmaras Sutcu Imam University

Collaborator

Source ClinicalTrials.gov

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