An interventional study of Custom-made positioning appliance-assisted mandibular segment repositioning and Conventional Manual Positioning in Dentofacial Deformities, sponsored by Sümer Münevveroğlu. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-15.
Sponsored by Sümer Münevveroğlu · Not applicable, Interventional, and Treatment
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.
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.
39 studies on the registry are indexed under Dentofacial Deformities; 15 are open to participants now.
This study's planned enrollment of 30 is below the median of 40 across 25 interventional studies indexed under Dentofacial Deformities.
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Exclusion Criteria:
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.
Procedure: Custom-made positioning appliance-assisted mandibular segment repositioning
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.
Procedure: Conventional Manual Positioning
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.
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.
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.
Time frame: 1 Month Postoperatively
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.
Time frame: Intraoperative
Plan to share: 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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