Mandibular Angle Fracture
Conditions
Keywords
Mandibular angle fracture, guided reduction and fixation
Brief summary
This study will evaluate the patient specific surgical stent and plate for guided reduction and fixation of mandibular angle fractures.
Detailed description
14 Patients were allocated into 2 groups: Group A underwent reduction using a patient-specific surgical reduction guide generated through virtual surgical planning, whereas Group B underwent conventional manual reduction Follow-up extended to 12 weeks. Clinical parameters included pain, operative time, postoperative occlusion, wound healing and mouth opening. Radiographic evaluation was conducted using computed tomography scans acquired preoperatively and postoperatively ,superimposition of the pre and postoperative models will be done to create error map and measure the accuracy
Interventions
DEVICEPatient specific surgical stents and plates for guided reduction and fixation of mandibular angle fixation
Patient specific surgical stents and plates for guided reduction and fixation of mandibular angle fixation
DEVICEfracture reduction performed using conventional intraoperative manual techniques without a reduction guide.
manual fracture reduction without a guide
Sponsors
Alexandria University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
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 (Guided Reduction Group): fracture reduction performed using a patient-specific surgical reduction guide derived from virtual surgical planning. Group B (Manual Reduction Group): fracture reduction performed using conventional intraoperative manual techniques without a reduction guide.
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. * Patients with mandibular angle fracture indicated for open reduction and internal fixation. * Presented within 2 weeks from trauma.
Exclusion criteria
* Infected fracture site. * Patients with systemic bone diseases.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of accuracy of surgical reduction and fixation | Day 1 | Evaluation of accuracy of surgical guide will be done using slicer and blender, and mimics 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. |
Secondary
| Measure | Time frame |
|---|---|
| Clinical evaluation for Intra-opreative time | Intra-opreative |
Countries
Egypt
Outcome results
None listed