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he goal of this clinical trial is to evaluate Z shaped bone plate in mandibular fracture treatment regarding post operative healing, function restoration and esthetic.
aims to answer are: In mandibular trauma population, what is the difference between internal fixation using conventional miniplates compared to z shaped bone plates regarding post operative healing, function restoration and esthetic?
Participants will be divided equally and randomly in 2 groups as follows:
Group A: eight patients treated with Z shaped bone plate. (Study group) Group B: eight patients restored with conventional two miniplates.(control group)
Introduction: Various miniplate systems have been developed in recent years including three-dimensional miniplate, microplates and bioresorbable plate, and their advantages and disadvantages have been compared and studied. To overcome the shortcomings of 3D plating system such as difficulty in adaptation and fixation in fractures involving the mental nerve, a Z plate has been designed. Aim: to evaluate Z shaped bone plates in mandibular fracture management clinically, radiographically, and histologically. Methodology: sixteen patients with mandibular fracture grouped to two groups group A managed by Z plates, group B managed by two miniplates. Patients will follow up clinically postoperative. Radiographic evaluation will be performed immediately postoperative, 1 month and 4 months Experimental study will be on dogs and histological evaluation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| z-plate | Experimental | mandibular fracture will be reduced and fixed with Z shaped bone plate |
|
| conventional Miniplate | Active Comparator | mandibular fracture will be reduced and fixed with conventional two miniplates. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| open reduction and internal fixation with bone plate | Procedure | mandibular fracture were reduced and fixed with bone plates. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Radiographic evaluation (Bone density ratio at fracture line ) measured using orthopantomograms (OPGs) by ImageJ software. | Radiographic evaluation using orthopantomograms (OPGs) is performed immediately postoperatively, at 1 month and 4 months. To assess bone density along the fracture line, a densitometric analysis was conducted using the ImageJ system. Digital images are analyzed using ImageJ software. The mean gray value of a region of interest (ROI) drawn along the entire length of the fracture line was calculated. This gray value represents the relative bone density within the fracture site. Range: 0.0 - 1.0 (unitless ratio). Higher values indicate greater bone density and better healing | within 1week postoperative, 1month, 4month |
| Postoperative pain assessed using the Visual Analog Scale (VAS) | postoperative pain assessed using the Visual Analog Scale (VAS). Range: 0 (no pain) - 10 (worst imaginable pain). Higher scores indicate worse pain | day 1 , day 3, and 1week postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical fracture stability evaluated by manual mobility test and tenderness on palpation. | Outcome: Stable vs. unstable fracture (binary measure) assessed through bimanual digital manipulation i. Stable >> no movement of fragments. ii. Nonstable>> presence of movement | 1 week postoperative,1month, 3 months, 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mohamed S. Hamed, professor | Oral and Maxillofacial Surgery, Faculty of Dentistry, Suez Canal University | Study Chair |
| Mohamed A. Elsholkamy, professor | Oral and Maxillofacial Surgery, Faculty of Dentistry, Suez Canal University | Study Director |
| Amr A. Gomaa, associate professor | plastic Surgery, Faculty of medicine, Suez Canal University | Study Director |
| Eman M. Eldemardash, assistant lecturer | Oral and Maxillofacial Surgery, Faculty of Dentistry, Suez Canal University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Suez Canal University hospital, Ismailia | Ismailia | 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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| ID | Term |
|---|---|
| D000070799 | Open Fracture Reduction |
| D005593 | Fracture Fixation, Internal |
| D001860 | Bone Plates |
| ID | Term |
|---|---|
| D005592 | Fracture Fixation |
| D019637 | Orthopedic Procedures |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
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| z-plates. | Procedure | mandibular fracture were reduced and fixed with z-plate miniplates. |
|
| conventional miniplates. | Procedure | mandibular fracture were reduced and fixed with conventional two miniplates. |
|
| D020196 |
| Trauma, Nervous System |
| D009422 | Nervous System Diseases |
| D012887 | Skull Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D016268 |
| Internal Fixators |
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
| D009984 | Orthopedic Fixation Devices |
| D009983 | Orthopedic Equipment |
| D013523 | Surgical Equipment |
| D053831 | Surgical Fixation Devices |