Dentofacial DeformitiesNCT07125963
Patient-Specific vs. Conventional Positioning in Sagittal Split Ramus Osteotomy
A study testing Custom-made positioning appliance-assisted mandibular segment repositioning and Conventional Manual Positioning in people with Dentofacial Deformities, run by Sümer Münevveroğlu at 1 site in Turkey (Türkiye).
Trial summary
This study aims to evaluate the clinical efficacy and positioning accuracy of a custom-made proximal segment positioning appliance designed for use in sagittal split ramus osteotomy (SSRO). The appliance is produced using STL-based digital planning and 3D printing technologies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dentofacial Deformities
- What is being tested?
- Custom-made positioning appliance-assisted mandibular segment repositioning and Conventional Manual Positioning
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Jan 2024to 30 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 scheduled to undergo bilateral sagittal split ramus osteotomy as part of orthognathic surgery
- Age ≥ 18 years
- Availability of preoperative and postoperative CT scans
- Consent to participate in the study
Who cannot join
- History of previous mandibular surgery
- Craniofacial syndromes or congenital deformities
- Incomplete radiological records
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istanbul Medipol University, Medipol Mega University Hospital
Istanbul, Bağcılar, 34218
Sümer Münevveroğlu, D.D.S., Ph.D., 00905386013666, sumer.munevveroglu@medipol.edu.tr
Sümer Münevveroğlu, D.D.S., Ph.D.
About this study
Official title: Comparison of a Patient-Specific Proximal Segment Positioning Appliance and the Conventional Method in Sagittal Split Ramus Osteotomy
This study aims to evaluate the clinical efficacy and positioning accuracy of a custom-made proximal segment positioning appliance designed for use in sagittal split ramus osteotomy (SSRO). The appliance is produced using STL-based digital planning and 3D printing technologies. In each patient, the appliance is applied to one side of the mandible while the contralateral side is positioned using the conventional manual method. This within-subject design enables direct comparison by eliminating inter-individual anatomical variability. The primary outcome is the accuracy of segment positioning, evaluated by 3D superimposition and deviation analysis of pre- and postoperative STL models. Secondary outcomes include surgical time, ease of use as rated by the surgeon, and postoperative temporomandibular joint symptoms. The study will enroll 30 adult patients undergoing SSRO or double-jaw surgery due to dentofacial deformities. The results are expected to provide high-level clinical evidence for the reliability of patient-specific appliances in orthognathic surgery.
Read the detailed description
Sagittal split ramus osteotomy (SSRO) is a widely used orthognathic surgery technique to correct mandibular deformities. During SSRO, accurate positioning of the proximal segment is critical for ensuring temporomandibular joint (TMJ) health, symmetry, and long-term surgical stability. However, conventional positioning relies heavily on the surgeon's visual judgment and experience, which may lead to postoperative complications such as condylar displacement, facial asymmetry, and TMJ dysfunction.
This prospective, randomized clinical study introduces a patient-specific proximal segment positioning appliance developed through STL-based 3D design using Blender and printed with biocompatible surgical guide resin via a Formlabs SLA 3D printer. Each patient will undergo SSRO (with or without Le Fort I osteotomy), and the custom appliance will be used to guide the proximal segment on one mandibular side. The opposite side will be positioned conventionally, allowing intra-patient comparison.
Postoperative CBCT images will be obtained at 1 month and converted to STL format. These models will be aligned with preoperative plans using MeshLab software to evaluate linear and rotational deviations. Surgical time, ease of application, and TMJ symptoms will be documented. Statistical analysis will include paired t-tests or Wilcoxon signed-rank tests depending on data distribution.
This study will generate clinically meaningful data regarding the effectiveness and safety of patient-specific guides in mandibular segment positioning. The proposed method also holds commercialization potential and may reduce intraoperative variability and dependence on surgeon experience.
- Conditions
- Dentofacial Deformities
- Being tested
- Custom-made positioning appliance-assisted mandibular segment repositioning, Conventional Manual Positioning
- Keywords
- Sagittal Split Ramus Osteotomy, Orthognathic Surgery, 3D Surgical Planning, Patient-Specific Guide, Proximal Segment Position
- Medical subject headings
- Dentofacial Deformities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Custom-made positioning appliance-assisted mandibular segment repositioningProcedure or surgery
A patient-specific surgical guide designed using STL-based digital planning in Blender and produced via 3D printing with biocompatible surgical resin (Formlabs SLA printer). Used to guide and stabilize the proximal mandibular segment during sagittal split ramus osteotomy.
Conventional Manual PositioningProcedure or surgery
The proximal mandibular segment is positioned manually by the surgeon based on visual and tactile feedback without the use of a positioning guide. This technique represents the standard method in sagittal split ramus osteotomy.
| Study group | Role | What they receive |
|---|---|---|
| Custom-made positioning appliance-assisted mandibular segment repositioning | Experimental | Patients receive a custom-made positioning appliance designed via STL-based planning and manufactured using 3D printing. The appliance is used to guide the proximal mandibular segment during sagittal split ramus osteotomy on one side of the mandible, aiming to improve positional accuracy. Receives: Procedure: Custom-made positioning appliance-assisted mandibular segment repositioning |
| Conventional Manual Positioning | Active comparator | On the contralateral side of the mandible, the proximal segment is positioned manually by the surgeon using standard visual and tactile feedback during sagittal split ramus osteotomy, without a guiding appliance. Receives: Procedure: Conventional Manual Positioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Deviation of the proximal mandibular segment from the preoperative plan
The deviation between the actual postoperative position of the proximal mandibular segment and the virtually planned position will be measured in millimeters using superimposed STL files in MeshLab software. The mean deviation value will be compared between the custom-made positioning appliance-assisted method and conventional manual positioning to assess positional accuracy.
Measured: 1 Month Postoperatively
Secondary outcomes (1)
Duration of Fixation After Split
The time required for fixation of the mandibular segments following sagittal split osteotomy will be recorded separately for each side. This period begins immediately after the osteotomy is completed and ends when rigid fixation is achieved. The recorded times will be compared between the custom-made positioning appliance-assisted method and the conventional manual method to evaluate potential differences in procedural efficiency.
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2025
- Study start25 Jan 2024
- Primary completion30 Jul 2026 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dentofacial DeformitiesStudies 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
- This study uses a split-mouth crossover design. Each patient receives both interventions: a custom-made positioning appliance is applied to one side of the mandible, while the contralateral side is positioned using the conventional manual method. This intra-patient comparison allows direct assessment of positional accuracy and clinical effectiveness between the two techniques.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sümer Münevveroğlu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sümer Münevveroğlu, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07125963
- Sponsor's protocol ID
- MEDIPOL-SSRO-001
- Status last verified
- Jan 2025
- First submitted
- 29 Jul 2025
- Last updated
- 15 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to privacy concerns and institutional policy restrictions regarding the sharing of de-identified clinical data.
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of a Patient-Specific Proximal Segment Positioning Appliance and the Conventional Method in Sagittal Split Ramus Osteotomy
- ClinicalTrials.gov ID
- NCT07125963
- Acronym / sponsor ID
- MEDIPOL-SSRO-001
- Conditions
- Dentofacial Deformities
- Keywords
- Sagittal Split Ramus Osteotomy, Orthognathic Surgery, 3D Surgical Planning, Patient-Specific Guide, Proximal Segment Position
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sümer MünevveroğluUniversity, hospital or other
- Study start
- 25 Jan 2024 (actual)
- Primary completion
- 30 Jul 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 15 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 study aims to evaluate the clinical efficacy and positioning accuracy of a custom-made proximal segment positioning appliance designed for use in sagittal split ramus osteotomy (SSRO). The appliance is produced using STL-based digital planning and 3D printing technologies. In each patient, the appliance is applied to one side of the mandible while the contralateral side is positioned using the conventional manual method. This within-subject design enables direct comparison by eliminating inter-individual anatomical variability. The primary outcome is the accuracy of segment positioning, evaluated by 3D superimposition and deviation analysis of pre- and postoperative STL models. Secondary outcomes include surgical time, ease of use as rated by the surgeon, and postoperative temporomandibular joint symptoms. The study will enroll 30 adult patients undergoing SSRO or double-jaw surgery due to dentofacial deformities. The results are expected to provide high-level clinical evidence for the reliability of patient-specific appliances in orthognathic surgery.
Detailed description
Sagittal split ramus osteotomy (SSRO) is a widely used orthognathic surgery technique to correct mandibular deformities. During SSRO, accurate positioning of the proximal segment is critical for ensuring temporomandibular joint (TMJ) health, symmetry, and long-term surgical stability. However, conventional positioning relies heavily on the surgeon's visual judgment and experience, which may lead to postoperative complications such as condylar displacement, facial asymmetry, and TMJ dysfunction.
This prospective, randomized clinical study introduces a patient-specific proximal segment positioning appliance developed through STL-based 3D design using Blender and printed with biocompatible surgical guide resin via a Formlabs SLA 3D printer. Each patient will undergo SSRO (with or without Le Fort I osteotomy), and the custom appliance will be used to guide the proximal segment on one mandibular side. The opposite side will be positioned conventionally, allowing intra-patient comparison.
Postoperative CBCT images will be obtained at 1 month and converted to STL format. These models will be aligned with preoperative plans using MeshLab software to evaluate linear and rotational deviations. Surgical time, ease of application, and TMJ symptoms will be documented. Statistical analysis will include paired t-tests or Wilcoxon signed-rank tests depending on data distribution.
This study will generate clinically meaningful data regarding the effectiveness and safety of patient-specific guides in mandibular segment positioning. The proposed method also holds commercialization potential and may reduce intraoperative variability and dependence on surgeon experience.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study uses a split-mouth crossover design. Each patient receives both interventions: a custom-made positioning appliance is applied to one side of the mandible, while the contralateral side is positioned using the conventional manual method. This intra-patient comparison allows direct assessment of positional accuracy and clinical effectiveness between the two techniques.
| Arm | Type | Receives |
|---|---|---|
| Custom-made positioning appliance-assisted mandibular segment repositioning | Experimental | Procedure: Custom-made positioning appliance-assisted mandibular segment repositioningPatients receive a custom-made positioning appliance designed via STL-based planning and manufactured using 3D printing. The appliance is used to guide the proximal mandibular segment during sagittal split ramus osteotomy on one side of the mandible, aiming to improve positional accuracy. |
| Conventional Manual Positioning | Active comparator | Procedure: Conventional Manual PositioningOn the contralateral side of the mandible, the proximal segment is positioned manually by the surgeon using standard visual and tactile feedback during sagittal split ramus osteotomy, without a guiding appliance. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients scheduled to undergo bilateral sagittal split ramus osteotomy as part of orthognathic surgery
- Age ≥ 18 years
- Availability of preoperative and postoperative CT scans
- Consent to participate in the study
Key exclusion criteria (3 listed)
- History of previous mandibular surgery
- Craniofacial syndromes or congenital deformities
- Incomplete radiological records
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 |
|---|---|---|
| Custom-made positioning appliance-assisted mandibular segment repositioningA patient-specific surgical guide designed using STL-based digital planning in Blender and produced via 3D printing with biocompatible surgical resin (Formlabs SLA printer). Used to guide and stabilize the proximal mandibular segment during sagittal split ramus osteotomy. | Procedure or surgery | Custom-made positioning appliance-assisted mandibular segment repositioning |
| Conventional Manual PositioningThe proximal mandibular segment is positioned manually by the surgeon based on visual and tactile feedback without the use of a positioning guide. This technique represents the standard method in sagittal split ramus osteotomy. | Procedure or surgery | Conventional Manual Positioning |
Primary outcome
Deviation of the proximal mandibular segment from the preoperative plan
Time frame: 1 Month Postoperatively
The deviation between the actual postoperative position of the proximal mandibular segment and the virtually planned position will be measured in millimeters using superimposed STL files in MeshLab software. The mean deviation value will be compared between the custom-made positioning appliance-assisted method and conventional manual positioning to assess positional accuracy.
1 secondary outcome
Duration of Fixation After Split
Time frame: Intraoperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2025.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to privacy concerns and institutional policy restrictions regarding the sharing of de-identified clinical data.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Custom-made positioning appliance-assisted mandibular segment repositioning and Conventional Manual Positioning in people with Dentofacial Deformities, run by Sümer Münevveroğlu 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 4 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 15 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sümer Münevveroğlu, D.D.S., Ph.D. (00905386013666, sumer.munevveroglu@medipol.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Deviation of the proximal mandibular segment from the preoperative plan (time frame: 1 Month Postoperatively). 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 Aug 2025.