Mandibular Class Iv Fractures
Conditions
Keywords
Per-bent plates, Class iv mandibular fractures, Surgical guide, patient-specific screw holes locating surgical guide
Brief summary
This study aims to overcome the limitations of current, standard approach of mandibular fracture reduction and fixation including improper alignment of segments, malocclusion, nerve affections and related teeth roots injury. The introduction of Computer Aided designing/Computer Aided manufacturing software has provided surgeons with an opportunity to perform virtual manipulations of computed tomography datasets preoperatively and production of corrected mandibular model for plate pre-bending and fabrication of plate locating surgical guide which provide accurate segment reduction and fixation with accurate post-operative occlusion and minimal post-operative complication.
Interventions
DEVICEpatient-specific screw holes locating surgical guide and pre-bent plates
Virtual reduction of the fracture will be done, followed by 3D printing of the corrected mandible model. Plates will be pre-bent on the model, then scanned in position to create a surgical guide for accurate screw hole placement during surgery.
DEVICE2 titanium per-bent mini plates
The fixation will be performed according to established surgical principles for managing class iv mandibular fractures, without patient-specific planning
Sponsors
Mohamed abdelsalam Gaber elkhouly
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patients with delayed mandibular class IV fracture need open reduction and internal fixation. * Patients with a medical history that did not hinder plate placement (uncontrolled diabetes) and adequate proper oral hygiene. * Both genders, males and females, will be included
Exclusion criteria
* General contraindications to surgery. * Patients with unfavorable or comminuted fractures. * Subjected to irradiation in the head and neck area less than 1 year before fixation. * Poor oral hygiene and motivation. * Uncontrolled diabetes. * Pregnant or nursing. * Substance abuse. * Psychiatric problems or unrealistic expectations. * Severe bruxism or clenching. * Immunosuppressed or immunocompromised. * Treated or under treatment with intravenous amino-bisphosphonates. * Patients participating in other studies, if the present protocol could not be properly followed.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of fracture reduction | Within one week postoperatively | Accuracy of fracture reduction, measured as the mean linear deviation (in millimeters) between the postoperative Computed Tomography scan and the preoperative virtual surgical plan Method of assessment: Postoperative Computed Tomography scans will be superimposed onto the preoperative virtual plan using 3D analysis software (e.g., Mimics/3-matic or equivalent). Linear and angular deviations of fracture segments will be calculated at predefined anatomical landmarks. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Occlusion | At 1 week, 1 month, 3 months, and 6 months postoperatively | change in occlusion will be assessed by a maxillofacial surgeon at each follow-up visit (1 week, 1 month, 3 months, 6 months postoperatively) using Angle's classification and clinical examination. Unit of Measure: Presence/absence of malocclusion (Yes/No) |
| Operation time | During the surgery | Total duration from skin incision to wound closure, recorded intraoperatively. |
Contacts
Primary ContactMohamed Abelsalam Gaber Elkhouly
Outcome results
None listed