Orthognathic SurgeryBlood flowNCT06661798
Evaluation of the Mental Foramen After Surgery Via Ultrasonography
A study testing orthognathic surgery, USG examination and Subjective evaluation - Neuro-sensitivity tests in people with Orthognathic Surgery, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial summary
Objective: This study aims to detect changes in blood flow in the mental foramen after surgery compared to before orthognathic surgery. Materials and Methods: This study will include a total of 16 patients, aged between 18-60, who were planned for orthognathic surgery due to malocclusion complaints. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Orthognathic Surgery
- What is being tested?
- orthognathic surgery, USG examination and Subjective evaluation - Neuro-sensitivity tests
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2024to 28 Mar 2025
- 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 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients over 18 years old,
- Patients who have reached skeletal maturity,
- Patients under 60 years old,
- Patients with skeletal Class II malocclusion indicated for orthognathic surgery,
- Patients with skeletal Class III malocclusion indicated for orthognathic surgery,
- Those who are willing to participate in the study
Who cannot join
- Patients with a systemic disease,
- Patients under 18 years old,
- Patients who have not completed their growth and development,
- Patients over 59 years old,
- Patients using neurological and psychiatric medications,
- Patients who have previously undergone surgery or experienced trauma in the mandibular region,
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- Patients with neurosensory dysfunction in the inferior alveolar nerve before surgery,
- Pregnant individuals or those suspected of being pregnant,
- Any local or systemic condition that may contraindicate general anesthesia
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bezmialem Vakif University
Istanbul, Fatih, 34093
About this study
Official title: Evaluation of Changes in Mental Foramen Blood Flow After Orthognathic Surgery Using Ultrasound
Objective: This study aims to detect changes in blood flow in the mental foramen after surgery compared to before orthognathic surgery.
Materials and Methods: This study will include a total of 16 patients, aged between 18-60, who were planned for orthognathic surgery due to malocclusion complaints. Patients will be evaluated clinically and radiologically before surgery, 1 week, 1 month, and 3 months after the surgery. Panoramic radiographs will be taken before surgery and 3 months after surgery, and a fractal analysis of the ROI area determined distal to the mental foramen will be performed. Pain will be scored from 1 to 5 using the Pinprick test before surgery, 1 week, 1 month, and 3 months after surgery, while pressure and neurosensitivity will be scored using VAS. Neurosensory evaluation will be performed using two-point discrimination (dividing the area between the lower lip and chin into 9 regions), and left-right discrimination will be checked using the brush test. Blood flow in the mental foramen will be evaluated using ultrasonography.
- Conditions
- Orthognathic Surgery
- Being tested
- orthognathic surgery, USG examination, Subjective evaluation - Neuro-sensitivity tests
- Keywords
- Mental foramen, orthognathic surgery, blood flow, ultrasonography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
orthognathic surgeryProcedure or surgery
Mandibular setback, Maxillary advancement, Bilateral sagital split osteotomy
USG examinationProcedure or surgery
Comparison of blood flow in the mental foramen before and 1week, 1 month and 3 month after orthognathic surgery using ultrasound examination
Subjective evaluation - Neuro-sensitivity testsProcedure or surgery
Direction determination, two-point separation, pinprick, and brush tests, along with neurosensitivity VAS and pressure VAS, were applied to the patients. These tests were performed before surgery (T0), seven days after surgery (T1), one month after surgery (T2), and three months after surgery (T3).
| Study group | Role | What they receive |
|---|---|---|
| Orthognathic surgery | Other | Patients who have reached skeletal maturity, have skeletal Class II or Class III malocclusion, and are indicated for orthognathic surgery due to malocclusion complaints Receives: Procedure: orthognathic surgery; Procedure: USG examination; Procedure: Subjective evaluation - Neuro-sensitivity tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in blood flow in the mental foramen after orthognathic surgery
Measured: From enrollment to 3 months after the end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2024
- Study start1 Oct 2024
- Primary completion28 Mar 2025
- Study completion28 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthognathic SurgeryStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif UniversityThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elifhan Alagoz, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06661798
- Sponsor's protocol ID
- 27.02.2024-E.142577
- Acronym
- Blood flow
- Status last verified
- Oct 2024
- First submitted
- 25 Oct 2024
- Last updated
- 15 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Changes in Mental Foramen Blood Flow After Orthognathic Surgery Using Ultrasound
- ClinicalTrials.gov ID
- NCT06661798
- Acronym / sponsor ID
- Blood flow / 27.02.2024-E.142577
- Conditions
- Orthognathic Surgery
- Keywords
- Mental foramen, orthognathic surgery, blood flow, ultrasonography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 28 Mar 2025 (actual)
- Study completion
- 28 Mar 2025 (actual)
- First posted
- 28 Oct 2024 (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.
Objective: This study aims to detect changes in blood flow in the mental foramen after surgery compared to before orthognathic surgery.
Materials and Methods: This study will include a total of 16 patients, aged between 18-60, who were planned for orthognathic surgery due to malocclusion complaints. Patients will be evaluated clinically and radiologically before surgery, 1 week, 1 month, and 3 months after the surgery. Panoramic radiographs will be taken before surgery and 3 months after surgery, and a fractal analysis of the ROI area determined distal to the mental foramen will be performed. Pain will be scored from 1 to 5 using the Pinprick test before surgery, 1 week, 1 month, and 3 months after surgery, while pressure and neurosensitivity will be scored using VAS. Neurosensory evaluation will be performed using two-point discrimination (dividing the area between the lower lip and chin into 9 regions), and left-right discrimination will be checked using the brush test. Blood flow in the mental foramen will be evaluated using ultrasonography.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Orthognathic surgery | Other | Procedure: orthognathic surgery, Procedure: USG examination, Procedure: Subjective evaluation - Neuro-sensitivity testsPatients who have reached skeletal maturity, have skeletal Class II or Class III malocclusion, and are indicated for orthognathic surgery due to malocclusion complaints |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patients over 18 years old,
- Patients who have reached skeletal maturity,
- Patients under 60 years old,
- Patients with skeletal Class II malocclusion indicated for orthognathic surgery,
- Patients with skeletal Class III malocclusion indicated for orthognathic surgery,
Key exclusion criteria (9 listed)
- Patients with a systemic disease,
- Patients under 18 years old,
- Patients who have not completed their growth and development,
- Patients over 59 years old,
- Patients using neurological and psychiatric medications,
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 |
|---|---|---|
| orthognathic surgeryMandibular setback, Maxillary advancement, Bilateral sagital split osteotomy | Procedure or surgery | Orthognathic surgery |
| USG examinationComparison of blood flow in the mental foramen before and 1week, 1 month and 3 month after orthognathic surgery using ultrasound examination | Procedure or surgery | Orthognathic surgery |
| Subjective evaluation - Neuro-sensitivity testsDirection determination, two-point separation, pinprick, and brush tests, along with neurosensitivity VAS and pressure VAS, were applied to the patients. These tests were performed before surgery (T0), seven days after surgery (T1), one month after surgery (T2), and three months after surgery (T3). | Procedure or surgery | Orthognathic surgery |
Primary outcome
Changes in blood flow in the mental foramen after orthognathic surgery
Time frame: From enrollment to 3 months after the end of surgery
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 Jul 2025.
- Individual participant dataSharing planned: No
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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 orthognathic surgery, USG examination and Subjective evaluation - Neuro-sensitivity tests in people with Orthognathic Surgery, run by Bezmialem Vakif University 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 6 inclusion and 9 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 Jul 2025. 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. 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?
Changes in blood flow in the mental foramen after orthognathic surgery (time frame: From enrollment to 3 months after the end of surgery). 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 Jul 2025.