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This randomized clinical trial aims to conduct a comprehensive clinical and radiographic evaluation by comparing the efficacy of standard titanium fixation plates with three dimensional custom plate in the management of sub-condylar fractures. By assessing the clinical outcomes, accuracy of reduction of the fracture segments, and bite force promoted by both fixation modalities.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3D Custom Plate group | Experimental | Patients in this group will undergo open reduction and internal fixation of displaced mandibular sub-condylar fractures using preoperatively designed and 3D-printed patient-specific titanium plates. The custom plate is designed based on patient CT data and includes extensions along the posterior border of the mandibular ramus and above the sigmoid notch to facilitate accurate fracture reduction and stable fixation. |
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| Standard titanium plates group | Active Comparator | Patients in this group will undergo open reduction and internal fixation of displaced mandibular sub-condylar fractures using the conventional technique, involving either two standard titanium miniplates or a single 2.3 mm titanium plate. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3D custom plate | Device | Custom 3D plate will be designed using preoperative CT and virtual surgical planning. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mandibular deviation on opening | Deviation in mm measured using midline reference. | 1 month, 3 months, and 6 months postoperatively. |
| Maximum mouth opening | Distance in mm between incisal edges during maximal mouth opening. | 1 month, 3 months, and 6 months postoperatively. |
| Measure | Description | Time Frame |
|---|---|---|
| Bite force | Bite force measured in Newtons at the molar region using a bite force recording device. | 1 month, 3 months, and 6 months postoperatively |
| Accuracy of fracture reduction | Evaluated by comparing preoperative CT with postoperative CT using 3D image superimposition analysis |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Esraa Mosaad | Contact | +201153918930 | esraa.tawfik@dentistry.cu.edu.eg |
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| ID | Term |
|---|---|
| D008337 | Mandibular Fractures |
| ID | Term |
|---|---|
| D007572 | Jaw Fractures |
| D008446 | Maxillofacial Injuries |
| D005151 | Facial Injuries |
| D006259 | Craniocerebral Trauma |
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| Standard titanium fixation plates | Device | The fixation will be performed according to established surgical principles for managing displaced mandibular sub-condylar fractures without patient-specific planning or customization. |
|
| Immediately postoperative (within 1 week) |
| D020196 |
| Trauma, Nervous System |
| D009422 | Nervous System Diseases |
| D012887 | Skull Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |