Mandibular Fracture, Virtual Plan of Mandibular Fracture
Conditions
Keywords
mandibular fracture, virtual surgical planning
Brief summary
This study will evaluate the accuracy of the use of 3-D printed reduction guide in treatment of mandibular fractures using two different methods of virtual planning.
Detailed description
This study will be conducted clinically on 24 patients with mandibular fracture divided into 2 groups, (group A) virtual planning will be done using the manual virtual reduction method and (group B) virtual planning will be done using the mirror image technique. Design of the reduction guide will be done in accordance with the virtual plan. The surgical reduction will be done with the aid of the guide.
Interventions
DEVICEMandibular fracture treatment by 3d printed guide where virtual planning will be done using the manual reduction technique.
Mandibular fracture treatment by 3d printed guide where virtual planning will be done using the manual reduction technique.
DEVICEMandibular fracture treatment by 3d printed guide where virtual planning will be done using the mirror image reduction technique.
Mandibular fracture treatment by 3d printed guide where virtual planning will be done using the mirror image reduction technique.
Sponsors
Alexandria University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Patients were allocated in a 1:1 ratio using an on-site computer software system with concealed allocation through sequentially numbered, opaque, sealed envelopes (SNOSE). (group A) virtual planning will be done using the manual virtual reduction method and (group B) virtual planning will be done using the mirror image technique.
Intervention model description
Randomized controlled clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Medically fit patients free from relevant conditions contraindicating surgery. * Unilateral mandibular fractures indicated for open reduction and internal fixation
Exclusion criteria
* Infected fracture site. * Patients with systemic bone diseases.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of accuracy of mandibular reduction of each surgical guide. | Immediately after the surgery | Evaluation of accuracy of surgical guide will be done using slicer and blender software with the aid of the preoperative and postoperative CT. Preoperative planning will be merged with the new CT data to identify the accuracy of reduction. Landmark-Based Positional Analysis was used to quantify positional accuracy of the reduced mandibular segment. Bilateral mandibular landmarks were selected to represent the spatial position of the fractured and adjacent segments. The selected landmarks included condylion (Co), gonion (Go), and mental foramen (MF), which are distributed across the mandibular ramus, angle, and body regions. linear distances to the three reference planes were recorded in millimeters. To provide a comprehensive three-dimensional representation of positional discrepancy, an asymmetry index (AI) was calculated for each bilateral landmark. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical evaluation of postoperative occlusion | 3 months | Assessment of occlusion will be done By checking the maximal intercuspal position (centric occlusion) to ensure proper occlusal relationship including molar relation, canine relation and midline centralization. The percentage of patients suffering from occlusal disturbances will be recorded. |
Countries
Egypt
Outcome results
None listed