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Two groups of patients with mandibular body fractures indicated for Open reduction internal fixation alone or in combination with fractures elsewhere in the mandible or midface. First group will be subjected to traditional titanium internal rigid fixation. Second group will be subjected to custom made PEEK plates.
Two groups of patients with mandibular body fractures indicated for Open reduction internal fixation alone or in combination with fractures elsewhere in the mandible or midface. First group will be subjected to traditional titanium internal rigid fixation. Second group will be subjected to custom made PEEK plates.
Inclusion criteria:
All subjects were required:
Exclusion criteria:
Interventions:
Eligible patients will be randomized in equal proportions between the study group (PEEK custom made plates) and the control group (titanium plates).
A- Computer-assisted PEEK custom made plates:
B- Conventional titanium plates:
Follow up:
Clinical evaluation will be performed at the first week postoperative. Computed tomography will be performed at the first week postoperative then patients will be recalled for clinical evaluation every week for one month. Final follow up visit will be at 3 months postoperative.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Custom made PEEK plate fixation | Experimental | Open Reduction Internal Fixation using Custom made PEEK plates. |
|
| Titanium plate fixation | Active Comparator | Open Reduction Internal Fixation using conventional titanium plating system. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Titanium plate fixation | Procedure | Under General Anesthesia, exposure of the fractured mandibular body segments will be done using a standardized surgical approach. Open Reduction Internal Fixation using conventional titanium plates will be performed. |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative occlusion | Restoration of normal patient occlusion will be assessed using Visual analog scale (VAS) (0-10) | 1 month postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy of the planned reduction | The accuracy of computer assisted PEEK custom made plates in open reduction and internal fixation of mandibular body fractures will be assessed using Mimics software, measuring unit (mm) | 1st week |
| Wound dehiscence |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rofaida A Ahmad, MSc | Contact | +201099669299 | ro_fy_at@yahoo.com | |
| Rofaida A Ahmad, MSc | Contact | +201099669299 | rofaidaatef14@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Khaled Amr, PhD | Faculty of Oral and Dental Medicine -Cairo University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Oral and Dental Medicine -Cairo University | Recruiting | Cairo | Giza Governorate | 12613 | Egypt |
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| Label | URL |
|---|---|
| Open reduction and rigid internal fixation of mandibular condylar fractures by an intraoral approach: a long-term follow-up study of 15 patients | View source |
| Accuracy of the Computer-Aided Surgical Simulation (CASS) System in the Treatment of Patients With Complex Craniomaxillofacial Deformity: A Pilot Study. | View source |
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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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Because the two interventions used in this trial are clearly different and easily recognized by the participants and investigators, neither the investigator nor participants can be blinded
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|
| Custom made PEEK plate fixation | Procedure | Under General Anesthesia, exposure of the fractured mandibular body segments will be done using a standardized surgical approach. Open Reduction Internal Fixation using custom made PEEK plates will be performed. |
|
|
Wound infection will be assessed via clinical assessment, measuring unit (Binary yes/no)
| 1 month postoperative |
| The need for 2nd surgery | Redo surgery will be assessed via clinical assessment, measuring unit (Binary yes/no) | 1 month postoperative |
| Operative time | Surgical time will be assessed via clinical assessment, measuring unit (hours) | During operation |
| A Comparative Evaluation of Fixation Techniques in Anterior Mandibular Fractures Using 2.0 mm Monocortical Titanium Miniplates Versus 2.4 mm Cortical Titanium Lag Screws | View source |
| Titanium osteosynthesis hardware in maxillofacial trauma surgery: to remove or remain? A retrospective study. | View source |
| Camerani, et al. Reconstruction of frontal bone using specific implant polyether-ether-ketone | View source |
| The effect of diabetes mellitus on osseous healing. | View source |
| Unfavourable outcomes in maxillofacial injuries: How to avoid and manage | View source |
| Stress-induced immune dysregulation: Implications for wound healing, infectious disease and cancer | View source |
| D020196 |
| Trauma, Nervous System |
| D009422 | Nervous System Diseases |
| D012887 | Skull Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |