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The aim of the study to evaluate the effect of customized V pattern plate fixation versus a conventional superior-inferior mini plates fixation of mandibular angle fracture on mouth opening and radio graphical parameters.
The mandibular angle is one of the most common sites for fractures, accounting for 23-42% of all cases of mandibular fractures. Moreover, mandibular angle fractures have the highest postoperative complications among all mandibular fractures, and the loosening of screws and fracturing of plates are main reasons for the complications.The most widely used treatment modality for mandibular angle fracture is the use of one miniplate fixation ,The other one uses two mini-plates, with a upper mini-plate fixed at the same place of previous treatment which corresponds to the tension band of the mandible, and the lower mini-plate fixed at the inferior border of the mandible which corresponds to the compression band of the mandible, however, based on recent experimental and clinical studies, the stability provided by the miniplate fixation of mandibular angle fractures has become a point of contention among surgeons .In order to decrease the need for plate removal, reduce the operative time and improve the stability of the fixation system, a customized V pattern plate design is an appropriate plate structure for fractured mandible using the minimum output values for stress of plate and displacement of bony segments to seek maximum reduction volume on an original plate .Patient satisfaction include: clinical parameters such are occlusion, pain, facial swelling, maximal mouth opening, sensory function, and surgical wound ,these should be evaluated postoperatively ,radio graphical evaluation is also an important parameter to assess adequate reduction of the fractured segments .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Customized V plate fixation | Experimental | Computed tomography (CT) scan of the Facial bones (Axial cuts, DICOM file, Gantry tilt zero and minimal thickness of 1mm )is taken for the patients and a customized V pattern plate |
|
| Conventional miniplates fixation | Active Comparator | Conventional superior-inferior miniplates fixation of mandibular angle fixation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Customized V plate fixation | Procedure | (CT) scan is taken for the patients and a customized V pattern plate will be designed .Intraoral approach will be done to expose the angle fracture.Fracture site will be exposed and reduced in normal anatomic position guided by the CAD/CAM plate. MMF will be done.Fracture fragments will be fixed using CAD/CAM plate . |
| Measure | Description | Time Frame |
|---|---|---|
| Mouth Opening | Mouth Opening is evaluated by measurement of maximal interincisal opening between maxilaary and mandibular central incisiors by the caliper and measuring unit is mm | Every week for 1 month ,3 months and 6 months postoperative |
| Radiographical parameters | Radiographical parameters (Bone Density) is detected through CT scan to evaluate bone density in Hounsfield unit in the area of plate fixation to determine the effect of the plate stress over the fracture site Measures format will be summarized as mean | At 3 and 6 months postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Occlusion | Occlusion will be evaluated by intraoral examination and write in dental chart whether normal or abnormal occlusion | immediate postoperative day |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hiba O Saleh, Phd.student | Contact | 00201010389391 | dr.hiba2013@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Hiba O Saleh, Phd.student | Cairo University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dentistry-Cairo University | Cairo | 11599 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38105847 | Derived | Saleh HO, Moussa BG, Salah Eddin KA, Noman SA, Salah AM. Assessment of CAD/CAM Customized V Pattern Plate Versus Standard Miniplates Fixation in Mandibular Angle Fracture (Randomized Clinical Trial). J Maxillofac Oral Surg. 2023 Dec;22(4):995-1005. doi: 10.1007/s12663-023-02027-x. Epub 2023 Oct 27. |
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| ID | Term |
|---|---|
| D008337 | Mandibular Fractures |
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D007572 | Jaw Fractures |
| D008446 | Maxillofacial Injuries |
| D005151 | Facial Injuries |
| D006259 | Craniocerebral Trauma |
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Because the two interventions used in this trial are easily recognized by the participants and the investigator, neither the investigator nor the participant can be blinded. But, assessor and the statistician will be blinded.
|
| Conventional miniplates fixation | Procedure | Intraoral approach will be done to expose the angle fracture.Fracture site will be exposed and reduced in normal anatomic position. MMF will be done.Fracture fragments will be fixed using conventional miniplates fixation of angle fracture. |
|
| D020196 |
| Trauma, Nervous System |
| D009422 | Nervous System Diseases |
| D012887 | Skull Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |