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To compare the effectiveness of custom-made (3D) titanium plates to standard two titanium mini plates in fixation of mandibular angle fracture.
Eighteen patients with mandibular angle fractures will be selected. In nine fractures, custom-made three dimensional titanium plates will be used for fracture fixation (study group); while in the other nine, conventional two mini plates will be used (control group),via intra oral approach (combined with transbuccal approach) for both groups. Patients will be evaluated clinically, and radiographically (immediate and four months post operative) to evaluate the bone density at the fracture line.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patients with recent mandibular angle fractures managed with custom-made 3D titanium plates | Experimental | patients that will undergo internal fixation with custom-made 3D titanium plates through intaoral and transbuccal approach . |
|
| patients with recent mandibular angle fractures managed with standared two mini plates | Experimental | patient that will undergo internal fixation with standared two mini plates through intaoral and transbuccal approach. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| custom-made 3D titanium plates | Device | custom-made 3D titanium plates through intaoral and transbuccal approach . |
|
| 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 Computed Tomography (CT) scan in Hounsfield Units (HU) | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Post operative pain | - Post operative pain This will be subjectively evaluated with a visual analogue scale (VAS) with values from 0 (no pain) to 10 (strongest pain). | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of dentistry, Alexandria university | Alexandria | 21523 | Egypt |
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Randomized controlled clinical trial
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Participants complying with the inclusion criteria will be randomly assigned using a computer-generated list of random numbers to one of the two arms. Allocation will be performed by a trial independent individual and the allocation ratio is intended to be equal. Allocation will be in equal blocks to ensure that the study groups have equal number of participants.
| standared two mini plates | Device | internal fixation with standared two mini plates through intaoral and transbuccal approach. |
|