Passiflora Incarnata for Dental Extraction Anxiety

NCT07790029 | Active Not Recruiting

• 1 other identifier: KSU-KAYGISIZ-2025-KAEK-53
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Dental Anxiety; Preoperative Anxiety

Keywords

Passiflora incarnata; Herbal anxiolytic; STAI (State-Trait Anxiety Inventory); Dental Anxiety

Outcome Measures

Primary Outcomes (1)

• 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

  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)

Study Arms (2)

Passiflora Group

EXPERIMENTAL

Participants received a single oral dose of Passiflora incarnata extract prior to dental extraction.

Dietary Supplement: Passiflora incarnata extract

Placebo Group

PLACEBO COMPARATOR

Participants received a matching placebo prior to dental extraction

Other: Placebo

Interventions

Passiflora incarnata extract DIETARY_SUPPLEMENT

A single oral dose of Pasila (Passiflora incarnata extract, 450 mg capsule) administered prior to dental extraction.

Passiflora Group

Placebo OTHER

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.

Placebo Group

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ömer faruk Kaygısız: lead
• Kahramanmaras Sutcu Imam University: collaborator

Study Sites (1)

Kahramanmaraş Sütçü İmam University Faculty of Dentistry

Kahramanmaraş, TR, 46100, Turkey (Türkiye)

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Participants were randomly allocated in a 1:1 ratio to one of two parallel groups: an intervention group receiving a single oral dose of Passiflora incarnata extract, and a control group receiving a matching placebo, prior to dental extraction

Study Record Dates

• First Submitted: August 24, 2026
• First Posted: August 27, 2026
• Study Start: December 17, 2025
• Primary Completion (Estimated): November 15, 2026
• Study Completion (Estimated): December 15, 2026
• Last Updated: August 27, 2026

Record last verified: 2026-08

Locations

TU (1)