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the study aims to compare InterFlex plate with conventional miniplates in management of symphyseal mandibular fracture clinically regarding pain, wound healing and postoperative occlusion, and radiographically regrading bone density.
A total of 18 patients with recent symphyseal mandibular fractures were allocated into two groups. Group A, comprising 9 patients, underwent treatment with the InterFlex plate, while Group B, also consisting of 9 patients, was treated with conventional two miniplates. Clinical evaluations were carried at multiple intervals up to 12 weeks postoperatively, with radiographic assessments performed immediately after surgery and at 12 weeks to measure mean bone density at the fracture line.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with anterior mandibular fracture managed with conventional miniplates | Active Comparator | Patients with anterior mandibular fracture managed with conventional miniplates |
|
| Patients with anterior mandibular fracture managed with InterFlex plates | Experimental | Patients with anterior mandibular fracture managed with InterFlex plates |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| conventional miniplates | Device | conventional miniplates in double configuration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Radiographic evaluation for the assessment of mean bone density at the fracture line | Mean bone density at the fracture line was assessed using Cone-Beam Computed Tomography (CBCT) scan in Hounsfield Units (HU) | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical evaluation for pain | Pain was assessed using Visual Analogue Scale (VAS) | six weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical evaluation for Intra-fragmentary mobility | Intra-fragmentary mobility was evaluated by bimanual palpation at the fracture site | six weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dentistry, Alexandria University | Alexandria | Alexandria Governorate | 21523 | Egypt |
all data will be de-identified to protect the participant data. patients signed an informed consent for the use of their medical records and data for study
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to any one who required them after deidentification
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Patients were allocated in a 1:1 ratio using an on-site computer software system with concealed allocation through sequentially numbered, opaque, sealed envelopes (SNOSE). Group A was treated with InterFlex plates, and Group B with conventional miniplates
| InterFlex plates | Device | InterFlex plates in configuration |
|