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| ID | Type | Description | Link |
|---|---|---|---|
| OMFS201301 | Other Identifier | faculty of oral and dental medicine,Cairo univeristy |
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| Name | Class |
|---|---|
| Thamar University | OTHER |
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Student's t test will be used to compare 3D and Champy's miniplate fixation. A value of P ≤ 0.05 will be considered statistically significant.
Careful extra and intraoral clinical examinations will be perform on all patients. The presence of lacerations, swelling, ecchymosis, occlusal disturbances, or broken, avulsed, or missing teeth will noted, and the mandibular movements, maximal interincisal opening, and nerve function will be recorded. Palpation of the mandible for areas of tenderness, segment mobility, bony crepitus, and tooth mobility will be also perform . Radiographic images (panoramic and posteroanterior) will be taken to evaluate the fracture. Immediately preoperatively, each patient will be given a standard dose of 1.5 g of Unasyn* and 8 mg of Epidron** intravenously.
-Surgical Technique:
After placement of arch bars, the fracture line will be exposed through extraoral a submandibular (Risdon) incision. Only the amount of soft tissue stripping necessary to visualize, reduce, and stabilize the fracture will be performed. Mobile teeth or teeth with apices that will be exposed in the fracture will be removed.
All a fracture site will be identified, reduced, and after obtaining satisfactory occlusion, temporary maxillomandibular fixation will be placed using either Erich's arch bar or Ivy loop eyelet wiring.
Fixation in group A will be achieved using a 3D curved strut miniplate* (Fig 1) , installed and stabilized with monocortical screws. The 3D plate will be place in such a way that a horizontal bar is perpendicular and a vertical bar is parallel to the fracture line. While in group B fixation will be perform by A single non compression miniplate with 4-hole 2-mm using 2-mm monocortical screws.
In both group fixation will be carried out through extraoral submandibular approach and placed in the neutral zone of the mandibular angle (between tension and compression areas).
After fixation of the fracture, intermaxillary fixation will be removed . And the incisions will be close in layers by absorbable suture while the skin closed by 5-0 nylon sutures. No drains will placed. and the occlusion will checked .
-Postsurgical Management:
Antibiotics will be continued through the preoperative period and for 5 to 7 days after surgery. And other medication to control swelling and pain will be administered. Chlorhexidine mouth rinse will be provided for all patient until removal of arch bars. Soft diet will be strongly recommend for 2 weeks then Pasty diet will be gradually regained .
-Postoperative Evaluation :
Radiographic follow-up (in the form of posteroanterior and panoramic radiographs) will used to evaluate the patients immediately and 2 and 4 months postoperatively. Patients returned 7 days after surgery for clinical evaluation . The patients will be examined radiographically for accuracy of the reduction, screw positioning, adverse reactions in the vicinity of screw placement, and bone healing. the complications encountered will be recorded by treatment scoring system and treated. The clinical evaluations will be performed by 1 surgeon at each institution.
The patients will also evaluated clinically for infection, nonunion, pain, hypoesthesia, and malocclusion. Malocclusion will assessed based on patient complaints. Criteria for infection will based on either of the following conditions: 1) purulent discharge from an incision and 2) serosanguineous drainage and a wound culture positive for a known pathogen. All the patients will evaluated postoperatively by a single assessor.
-Statically analysis :
Student's t test will be used to compare 3D and Champy's miniplate fixation. A value of P ≤ 0.05 will be considered statistically significant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard titanium miniplate- single non compression miniplate | Active Comparator | fixation will be perform by A single non compression miniplate with 4-hole 2-mm using 2-mm monocortical screws at superior border of the mandible according to ideal lines of osteosynthesis. |
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| three dimensional titanium miniplate | Experimental | 3D curved strut miniplate* (Universal Mandible System, Stryker-Lei binger, Freiburg, Germany) , installed and stabilized with monocortical screws. The 3D plate will be place in such a way that a horizontal bar is perpendicular and a vertical bar is parallel to the fracture line. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3D titanium miniplate | Device | for study group by using 3D titanium miniplate under open reduction under general anesthesia with mono cortical screw, while in control group single titanium miniplate at superior border with mono cortical screw according to ideal line of osteosynthesis of champy |
| Measure | Description | Time Frame |
|---|---|---|
| postoperative complications |
| 6 monuths |
| Measure | Description | Time Frame |
|---|---|---|
| Radiographic follow-up | The patients will be examined radiographically for accuracy of the reduction, screw positioning, adverse reactions in the vicinity of screw placement, and bone healing by using digora software. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| mouth opening | BY USING BOELY GAUGE IN MILLIMTER | 7 days |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Oral and Maxillofacial SurgeryFaculty of Oral and Dental Medicine | Cairo | Giza Governorate | 17445 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25457871 | Derived | Al-Moraissi EA, Mounair RM, El-Sharkawy TM, El-Ghareeb TI. Comparison between three-dimensional and standard miniplates in the management of mandibular angle fractures: a prospective, randomized, double-blind, controlled clinical study. Int J Oral Maxillofac Surg. 2015 Mar;44(3):316-21. doi: 10.1016/j.ijom.2014.10.012. Epub 2014 Nov 15. |
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| Standard titanium miniplate- single non compression miniplate | Device | single non compression miniplate placed at superior border with monocortical screws via intraoral approach |
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