Orthognathic Surgical ProceduresNCT06662331
Effects of Low Medial Ramus Osteotomy on Neurosensorial Recovery During Post-Operative Period
A study testing Bilateral Sagittal Split Osteotomy in people with Orthognathic Surgical Procedures, run by Ali Törel Saygı at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to compare the post-operative neurosensorial disturbances of Hunsuck-Epkerr and "low and short medial osteotomy" modifications of sagittal split ramus osteotomy. Patients at the ages of 18-35 with dentofacial deformity who applied for orthognathic surgery were included in the present study. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Orthognathic Surgical Procedures
- What is being tested?
- Bilateral Sagittal Split Osteotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2023to 30 Jun 2024
- 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 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with dentofacial deformity who needs orthognatic surgery
Who cannot join
- The patients with medical conditions that may affect the potential of nerve regeneration,
- The patient who need additional osteotomies such as genioplasty or mandibular subapical segmental osteotomies
- The patients with bad split or interrupted IAN
- The patients with more than 5 mm expected buccal osseous gap between proximal and distal segments
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Low Medial Ramus Osteotomy Performed During Bilateral Sagittal Split Osteotomy on Neurosensorial Recovery During Post-Operative Period
The aim of this study is to compare the post-operative neurosensorial disturbances of Hunsuck-Epkerr and "low and short medial osteotomy" modifications of sagittal split ramus osteotomy. Patients at the ages of 18-35 with dentofacial deformity who applied for orthognathic surgery were included in the present study. The present study performed with split-mouth randomised controlled trial design, therefore osteotomies on one side were performed with Hunscuk-Epkerr modification and the contralateral side with low and short medial osteotomy modification. Double blinded evaluations of neuro sensorial alterations were performed at the 1st, 3rd and 6th months post-operatively. Painful stimuli, two-point discrimination, pressure and brush stroke direction tests were evaluated. Subjective neurosensorial recovery was also evaluated with VAS scores given by patients.
- Conditions
- Orthognathic Surgical Procedures
- Being tested
- Bilateral Sagittal Split Osteotomy
- Keywords
- orthognathic surgery, osteotomy modification
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilateral Sagittal Split OsteotomyProcedure or surgery
A surgical procedure to correct dentofacial deformities
| Study group | Role | What they receive |
|---|---|---|
| Hunsuck-Epker Modification | Experimental | A kind of ostoeotomy modification used during bilateral sagittal Receives: Procedure: Bilateral Sagittal Split Osteotomy |
| Low and short medial osteotomy | Experimental | A kind of ostoeotomy modification used during bilateral sagittal Receives: Procedure: Bilateral Sagittal Split Osteotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Sensory Recovery
Kind of scale, calculated with different neurosensorial investigation methods. Scored between S0-S4. S0 means total sensory loss, S4 means total sensory recovery.
Measured: 6 months
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 Jan 2023
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthognathic Surgical ProceduresStudies 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
- Crossover
- Model description
- Double Blind
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ali Törel Saygı
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ali Törel Saygı, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06662331
- Sponsor's protocol ID
- 22/3
- Status last verified
- Oct 2024
- First submitted
- 25 Oct 2024
- Last updated
- 28 Oct 2024
- 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 28 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Low Medial Ramus Osteotomy Performed During Bilateral Sagittal Split Osteotomy on Neurosensorial Recovery During Post-Operative Period
- ClinicalTrials.gov ID
- NCT06662331
- Acronym / sponsor ID
- 22/3
- Conditions
- Orthognathic Surgical Procedures
- Keywords
- orthognathic surgery, osteotomy modification
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Ali Törel SaygıUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (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.
The aim of this study is to compare the post-operative neurosensorial disturbances of Hunsuck-Epkerr and "low and short medial osteotomy" modifications of sagittal split ramus osteotomy. Patients at the ages of 18-35 with dentofacial deformity who applied for orthognathic surgery were included in the present study. The present study performed with split-mouth randomised controlled trial design, therefore osteotomies on one side were performed with Hunscuk-Epkerr modification and the contralateral side with low and short medial osteotomy modification. Double blinded evaluations of neuro sensorial alterations were performed at the 1st, 3rd and 6th months post-operatively. Painful stimuli, two-point discrimination, pressure and brush stroke direction tests were evaluated. Subjective neurosensorial recovery was also evaluated with VAS scores given by patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Double Blind
| Arm | Type | Receives |
|---|---|---|
| Hunsuck-Epker Modification | Experimental | Procedure: Bilateral Sagittal Split OsteotomyA kind of ostoeotomy modification used during bilateral sagittal |
| Low and short medial osteotomy | Experimental | Procedure: Bilateral Sagittal Split OsteotomyA kind of ostoeotomy modification used during bilateral sagittal |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients with dentofacial deformity who needs orthognatic surgery
Key exclusion criteria (4 listed)
- The patients with medical conditions that may affect the potential of nerve regeneration,
- The patient who need additional osteotomies such as genioplasty or mandibular subapical segmental osteotomies
- The patients with bad split or interrupted IAN
- The patients with more than 5 mm expected buccal osseous gap between proximal and distal segments
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 |
|---|---|---|
| Bilateral Sagittal Split OsteotomyA surgical procedure to correct dentofacial deformities | Procedure or surgery | Hunsuck-Epker Modification, Low and short medial osteotomy |
Primary outcome
Functional Sensory Recovery
Time frame: 6 months
Kind of scale, calculated with different neurosensorial investigation methods. Scored between S0-S4. S0 means total sensory loss, S4 means total sensory recovery.
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 28 Oct 2024.
- 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 Bilateral Sagittal Split Osteotomy in people with Orthognathic Surgical Procedures, run by Ali Törel Saygı 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 1 inclusion and 4 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 28 Oct 2024. 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?
Functional Sensory Recovery (time frame: 6 months). 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 28 Oct 2024.