Dental AnxietyNCT07790029
Passiflora Incarnata for Dental Extraction Anxiety
A study testing Passiflora incarnata extract in people with Dental Anxiety and Preoperative Anxiety, run by Ömer faruk Kaygısız at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Dental Anxiety, Preoperative Anxiety
- What is being tested?
- Passiflora incarnata extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Aug 2026to 10 Oct 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kahramanmaraş Sütçü İmam University Faculty of Dentistry
Kahramanmaraş, TR, 46100
About this study
Official title: 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
Read the detailed description
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
- Conditions
- Dental Anxiety, Preoperative Anxiety
- Being tested
- Passiflora incarnata extract, Placebo
- Keywords
- Passiflora incarnata, Herbal anxiolytic, STAI (State-Trait Anxiety Inventory), Dental Anxiety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Passiflora incarnata extractDietary supplement
A single oral dose of Pasila (Passiflora incarnata extract, 450 mg capsule) administered prior to dental extraction.
PlaceboOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Passiflora Group | Experimental | Participants received a single oral dose of Passiflora incarnata extract prior to dental extraction. Receives: Dietary Supplement: Passiflora incarnata extract |
| Placebo Group | Placebo comparator | Participants received a matching placebo prior to dental extraction Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2026
- Study start25 Aug 2026
- Primary completion25 Sep 2026
- Study completion10 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ömer faruk Kaygısız
- Sponsor type
- University, hospital or other
- Collaborators
- Kahramanmaras Sutcu Imam University
- Responsible party
- Sponsor-investigator, Ömer faruk Kaygısız, University of Gaziantep
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07790029
- Sponsor's protocol ID
- KSU-KAYGISIZ-2025-KAEK-53
- Status last verified
- Oct 2026
- First submitted
- 24 Aug 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Passiflora Incarnata on Dental Extraction Anxiety A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07790029
- Acronym / sponsor ID
- KSU-KAYGISIZ-2025-KAEK-53
- Conditions
- Dental Anxiety, Preoperative Anxiety
- Keywords
- Passiflora incarnata, Herbal anxiolytic, STAI (State-Trait Anxiety Inventory), Dental Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Ömer faruk KaygısızUniversity, hospital or other
- Collaborators
- Kahramanmaras Sutcu Imam University
- Study start
- 25 Aug 2026 (actual)
- Primary completion
- 25 Sep 2026 (actual)
- Study completion
- 10 Oct 2026 (actual)
- First posted
- 27 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Passiflora Group | Experimental | Dietary Supplement: Passiflora incarnata extractParticipants received a single oral dose of Passiflora incarnata extract prior to dental extraction. |
| Placebo Group | Placebo comparator | Other: PlaceboParticipants received a matching placebo prior to dental extraction |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Passiflora incarnata extractA single oral dose of Pasila (Passiflora incarnata extract, 450 mg capsule) administered prior to dental extraction. | Dietary supplement | Passiflora Group |
| PlaceboA 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. | Other | Placebo Group |
Primary outcome
Change in State-Trait Anxiety Inventory (STAI) State Anxiety Score
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)
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Passiflora incarnata extract in people with Dental Anxiety and Preoperative Anxiety, run by Ömer faruk Kaygısız at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in State-Trait Anxiety Inventory (STAI) State Anxiety Score (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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.