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This proposed study aims at creating a computer designed patient specific device and titanium plates, that are 3D manufactured in accordance to a preoperative computer aided virtual surgical procedure, aiming to obtain proper alignment of fractured segments of the lower jaw and restore proper teeth positioning therefore overcoming the possible complications of the conventional methods.
Recruited participants will be randomly allocated to a treatment groupp, whether the novel method group or a standard treatment group.
Preoperative panoramic radiograph and a Computed tomography scan will be obtained for each patient.
Surgical procedure will be conducted unde general anesthetic. Medications will be prescribed after surgery and instructions will be given to each patient.
Follow up will be on a weekly basis for the first 6 weeks followed by a followup visit once a month for 6 months.
Postoperative panoramic radiograph and a Computed tomography scan will be obtained at 1 week after the surgical procrdure and again 6 months later.
Digital data obtained from computed tomography scans along with clinical data will be analysed and studied to determine the accuracy of the computer aided device and for comparison with the standard method of treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Custom made reduction guides and 3D grid plates | Experimental | Mandibular angle fracture reduction and fixation using digitally designed and fabricated patient specific fracture reduction/plate positioning guide and customized 3D grid plate |
|
| Stock titanium plates | Active Comparator | Mandibular angle fracture reduction and fixation using a single superior border 2.0 miniplate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CAD/CAM patient specfifc fracture reduction/plate guide and customized 3D grid plate | Procedure | Mandibular angle fracture reduction and fixation using digitally designed and fabricated patient specific fracture reduction/plate positioning guide and customized 3D grid plate |
| Measure | Description | Time Frame |
|---|---|---|
| Guide accuracy in repositioning of the fractured segments and in comparison to the preoperative 3D virtual surgical plan. | Accuracy of postoperative reduction by superimposition of 3D CT data on a 3D specialized software | Outcome will be assessed with preoperative CT (T1-Week 1)immediate postoperative CT at (T3-Week 3) |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative occlusion | Assessment of postoperative occlusion clinically using a millimeter caliper, occlusion will be categorized into; satisfactory (no gap), mild derangement (gap of 1-2 mm) and deranged (gap more than 2 mm) | Outcome will be assessed clinically at T2 (Week 2) and T3 (Week 3) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dentistry, Cairo University | Cairo | Egypt |
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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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| Champy's techqniue | Procedure | Mandibular angle fracture reduction and fixation using a single superior border 2.0 miniplate |
|
| D020196 |
| Trauma, Nervous System |
| D009422 | Nervous System Diseases |
| D012887 | Skull Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |