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This study is a prospective randomized controlled clinical trial. It was performed on sixteen patients with anterior mandibular fractures, to compare Double Y-shaped plates and Lag Screws in fracture fixation from clinical and radiographic perspectives.
This study is a prospective randomized controlled clinical trial. It was performed on sixteen patients with anterior mandibular fractures, selected from those admitted to the Emergency Department of Alexandria University Hospital. Ethical approval for the study was obtained from the regional Ethical Review Board of the Faculty of Dentistry, Alexandria University. A written informed consent was signed by patients before the operation.
Patients were divided equally into two groups, each consisting of eight patients. Assignment of each patient into one of either group was done using computer random numbers.
Group 1: underwent open reduction and internal fixation using two lag screws. Group 2: underwent open reduction and internal fixation using double Y-shaped plates.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lag Screws | Active Comparator | Group 1: underwent open reduction and internal fixation using two lag screws. |
|
| Double Y-shaped plates | Active Comparator | Group 2: underwent open reduction and internal fixation using double Y-shaped plates. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lag Screws | Device | Method of internal fixation |
| |
| double Y-shaped plates |
| Measure | Description | Time Frame |
|---|---|---|
| progress of fracture healing in the postoperative period | Measurement of bone density in the fracture line using CBCT at 6 points and calculation of mean bone density | after 6 months |
| Sensory nerve function using dental probe to assess sensory changes along mental nerve distribution and comparing it to the contralateral side | Detection of nerve injury by examining sensory nerve function using dental probe to assess sensory changes along mental nerve distribution and comparing it to the contralateral side | up to 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dentistry | Alexandria | 21411 | 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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| Device |
Method of internal fixation |
|
| D020196 |
| Trauma, Nervous System |
| D009422 | Nervous System Diseases |
| D012887 | Skull Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |