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This study aims to overcome the limitations of current, standard approach of mandibular fracture reduction and fixation including improper alignment of segments, malocclusion, nerve affections and related teeth roots injury. The introduction of Computer Aided designing/Computer Aided manufacturing software has provided surgeons with an opportunity to perform virtual manipulations of computed tomography datasets preoperatively and production of corrected mandibular model for plate pre-bending and fabrication of plate locating surgical guide which provide accurate segment reduction and fixation with accurate post-operative occlusion and minimal post-operative complication.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patient-specific screw holes locating surgical guide and pre-bent plates osteosynthesis | Experimental | Patients In this group will be reduced using patient computer-guided specific screw holes locating guide and pre-bent plates(2.3 for inferior border and 2.0 for superior border) |
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| classical work-flow | Active Comparator | Patients In this group will be reduced by classical reduction and fixation protocol |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| patient-specific screw holes locating surgical guide and pre-bent plates | Device | Virtual reduction of the fracture will be done, followed by 3D printing of the corrected mandible model. Plates will be pre-bent on the model, then scanned in position to create a surgical guide for accurate screw hole placement during surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy of fracture reduction | Accuracy of fracture reduction, measured as the mean linear deviation (in millimeters) between the postoperative Computed Tomography scan and the preoperative virtual surgical plan Method of assessment: Postoperative Computed Tomography scans will be superimposed onto the preoperative virtual plan using 3D analysis software (e.g., Mimics/3-matic or equivalent). Linear and angular deviations of fracture segments will be calculated at predefined anatomical landmarks. | Within one week postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Occlusion | change in occlusion will be assessed by a maxillofacial surgeon at each follow-up visit (1 week, 1 month, 3 months, 6 months postoperatively) using Angle's classification and clinical examination. Unit of Measure: Presence/absence of malocclusion (Yes/No) | At 1 week, 1 month, 3 months, and 6 months postoperatively |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mohamed Abelsalam Gaber Elkhouly | Contact | 01009837389 | mohamed.gaber@dentistry.cu.edu.eg |
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|
| 2 titanium per-bent mini plates | Device | The fixation will be performed according to established surgical principles for managing class iv mandibular fractures, without patient-specific planning |
|
| Operation time |
Total duration from skin incision to wound closure, recorded intraoperatively. |
| During the surgery |