Orthognathic Surgical ProceduresNCT07118605
Minimally Invasive Sagittal Split Ramus Osteotomy
A study testing Minimally Invasive Sagittal Split Ramus Osteotomy and Conventional Sagittal Split Ramus Osteotomy in people with Orthognathic Surgical Procedures, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial summary
This randomized, double-blind, controlled, split-mouth clinical trial investigates the effects of two different surgical approaches - the conventional technique and a minimally invasive technique - during bilateral sagittal split ramus osteotomy (SSRO) for mandibular deformity correction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Orthognathic Surgical Procedures
- What is being tested?
- Minimally Invasive Sagittal Split Ramus Osteotomy and Conventional Sagittal Split Ramus Osteotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Feb 2024to 1 Nov 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who underwent sagittal split ramus osteotomy for mandibular dentofacial deformity
- Patients classified as ASA I or II
- Patients over 18 years of age
Who cannot join
- Patients with uncontrolled diabetes
- Patients with metabolic bone diseases (e.g., hyperparathyroidism, Paget's disease)
- Patients with syndromic conditions (e.g., Pierre Robin syndrome, Treacher Collins syndrome)
- Patients who had previously undergone mandibular surgery due to trauma, tumors, or cysts and had sequelae involving the lower jaw
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Erciyes University Faculty of Dentistry Department of Oral and Maxillofacial Surgery
Kayseri, 38039
About this study
Official title: Exploring the Potential of Minimally Invasive Sagittal Split Ramus Osteotomy to Transform Patient Outcomes: A Randomized, Double-Blind, Controlled Split Mouth Study
This randomized, double-blind, controlled, split-mouth clinical trial investigates the effects of two different surgical approaches - the conventional technique and a minimally invasive technique - during bilateral sagittal split ramus osteotomy (SSRO) for mandibular deformity correction. The study will be conducted at the Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Erciyes University.
Each patient will receive both surgical techniques, randomly assigned to either side of the mandible. All procedures will be performed under general anesthesia by the same surgeon. Intraoperative outcomes including bleeding volume and operative time will be recorded. Postoperative evaluations will be conducted on day 1, weeks 1, 2, and 4, and at 3 months to assess pain and swelling.
This study aims to determine whether the minimally invasive SSRO technique can improve surgical efficiency and reduce postoperative morbidity compared to the conventional approach, without compromising treatment outcomes.
- Conditions
- Orthognathic Surgical Procedures
- Being tested
- Minimally Invasive Sagittal Split Ramus Osteotomy, Conventional Sagittal Split Ramus Osteotomy
- Keywords
- minimally invasive, sagittal split ramus osteotomy, orthognathic surgery, patient outcomes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimally Invasive Sagittal Split Ramus OsteotomyProcedure or surgery
This procedure involves a limited mucosal incision and tunnel dissection technique combined with low and short osteotomy and minimal soft tissue manipulation. The goal is to reduce surgical trauma, edema, blood loss, and operative time while maintaining clinical effectiveness.
Conventional Sagittal Split Ramus OsteotomyProcedure or surgery
This procedure follows the traditional wide exposure technique with full-thickness mucoperiosteal flap elevation. This method is widely accepted and serves as the control for comparison.
| Study group | Role | What they receive |
|---|---|---|
| Minimally Invasive Sagittal Split Ramus Osteotomy | Experimental | Not described Receives: Procedure: Minimally Invasive Sagittal Split Ramus Osteotomy |
| Conventional Sagittal Split Ramus Osteotomy | Active comparator | Not described Receives: Procedure: Conventional Sagittal Split Ramus Osteotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operative Time
Operative time will be measured in minutes, separately for the right and left sides, from the initial skin incision to the final suture placement, using a chronometer.
Measured: Intraoperative period (from skin incision to final suture placement)
Bleeding
Bleeding volume will be measured in milliliters from the initial skin incision to the final suture placement, using separate calibrated aspirators for the left and right sides.
Measured: Intraoperative period (from skin incision to final suture placement)
Secondary outcomes (2)
Postoperative Edema
The 3dMD imaging system (3dMD, Atlanta, GA) and 3dMD Vultus software were used to evaluate the amount of postoperative edema. Three-dimensional images were taken with the teeth in maximum intercuspation, lips relaxed, and eyes open on postoperative days 1, 7, 14, 30, and 90. Edema was calculated separately for the right and left sides and was recorded as surface area in square centimeters (cm²).
Measured: Postoperative days 1, 7, 14, and 30
Postoperative Pain
Postoperative pain was evaluated using the Visual Analogue Scale for the right and left sides separately. In this scale, '0' meant no pain, and '100' represented maximum pain. Patients were questioned at postoperative 1st, 2nd, 4th, 6th, 8th, 10th, and 12th hours, and the results were recorded in the patient follow-up form.
Measured: Postoperative hours 1, 2, 4, 6, 8, 10, and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2025
- Study start19 Feb 2024
- Primary completion25 Jul 2024
- Study completion1 Nov 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, İbrahim Mert Erkan, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07118605
- Sponsor's protocol ID
- 2024/110
- Status last verified
- Jul 2025
- First submitted
- 29 Jul 2025
- Last updated
- 12 Aug 2025
- Results posted
- 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 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Potential of Minimally Invasive Sagittal Split Ramus Osteotomy to Transform Patient Outcomes: A Randomized, Double-Blind, Controlled Split Mouth Study
- ClinicalTrials.gov ID
- NCT07118605
- Acronym / sponsor ID
- 2024/110
- Conditions
- Orthognathic Surgical Procedures
- Keywords
- minimally invasive, sagittal split ramus osteotomy, orthognathic surgery, patient outcomes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 19 Feb 2024 (actual)
- Primary completion
- 25 Jul 2024 (actual)
- Study completion
- 1 Nov 2024 (actual)
- First posted
- 12 Aug 2025 (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 randomized, double-blind, controlled, split-mouth clinical trial investigates the effects of two different surgical approaches - the conventional technique and a minimally invasive technique - during bilateral sagittal split ramus osteotomy (SSRO) for mandibular deformity correction. The study will be conducted at the Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Erciyes University.
Each patient will receive both surgical techniques, randomly assigned to either side of the mandible. All procedures will be performed under general anesthesia by the same surgeon. Intraoperative outcomes including bleeding volume and operative time will be recorded. Postoperative evaluations will be conducted on day 1, weeks 1, 2, and 4, and at 3 months to assess pain and swelling.
This study aims to determine whether the minimally invasive SSRO technique can improve surgical efficiency and reduce postoperative morbidity compared to the conventional approach, without compromising treatment outcomes.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Minimally Invasive Sagittal Split Ramus Osteotomy | Experimental | Procedure: Minimally Invasive Sagittal Split Ramus Osteotomy |
| Conventional Sagittal Split Ramus Osteotomy | Active comparator | Procedure: Conventional Sagittal Split Ramus Osteotomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who underwent sagittal split ramus osteotomy for mandibular dentofacial deformity
- Patients classified as ASA I or II
- Patients over 18 years of age
Key exclusion criteria (4 listed)
- Patients with uncontrolled diabetes
- Patients with metabolic bone diseases (e.g., hyperparathyroidism, Paget's disease)
- Patients with syndromic conditions (e.g., Pierre Robin syndrome, Treacher Collins syndrome)
- Patients who had previously undergone mandibular surgery due to trauma, tumors, or cysts and had sequelae involving the lower jaw
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 |
|---|---|---|
| Minimally Invasive Sagittal Split Ramus OsteotomyThis procedure involves a limited mucosal incision and tunnel dissection technique combined with low and short osteotomy and minimal soft tissue manipulation. The goal is to reduce surgical trauma, edema, blood loss, and operative time while maintaining clinical effectiveness. | Procedure or surgery | Minimally Invasive Sagittal Split Ramus Osteotomy |
| Conventional Sagittal Split Ramus OsteotomyThis procedure follows the traditional wide exposure technique with full-thickness mucoperiosteal flap elevation. This method is widely accepted and serves as the control for comparison. | Procedure or surgery | Conventional Sagittal Split Ramus Osteotomy |
Primary outcome
Operative Time
Time frame: Intraoperative period (from skin incision to final suture placement)
Operative time will be measured in minutes, separately for the right and left sides, from the initial skin incision to the final suture placement, using a chronometer.
Bleeding
Time frame: Intraoperative period (from skin incision to final suture placement)
Bleeding volume will be measured in milliliters from the initial skin incision to the final suture placement, using separate calibrated aspirators for the left and right sides.
2 secondary outcomes
Postoperative Edema
Time frame: Postoperative days 1, 7, 14, and 30
Postoperative Pain
Time frame: Postoperative hours 1, 2, 4, 6, 8, 10, and 12
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 12 Aug 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 Minimally Invasive Sagittal Split Ramus Osteotomy and Conventional Sagittal Split Ramus Osteotomy in people with Orthognathic Surgical Procedures, run by TC Erciyes 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 3 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 12 Aug 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?
Operative Time (time frame: Intraoperative period (from skin incision to final suture placement)). The study lists 2 primary outcomes in all. 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 12 Aug 2025.