Mandibular Angle Fracture
Conditions
Keywords
CAD/CAM, Patient-Specific Plate, Mandibular Fracture, Angle Fracture, Titanium Plate, Virtual Surgical Planning, Maxillofacial Trauma
Brief summary
This study evaluates the accuracy and clinical effectiveness of patient-specific titanium plates designed using CAD/CAM technology for the reduction and fixation of mandibular angle fractures. The customized plates are manufactured to match each patient's anatomical morphology, aiming to improve surgical precision, minimize operative time, and enhance postoperative stability. The study assesses clinical outcomes including pain, edema, occlusion, sensory recovery, maximal mouth opening, and radiographic bone healing across multiple follow-up periods. The goal is to determine whether patient-specific plates offer superior clinical and radiographic results compared with conventional fixation methods.
Detailed description
This clinical study investigates the use of computer-aided design and computer-aided manufacturing (CAD/CAM) technology to fabricate patient-specific titanium plates for the reduction and fixation of mandibular angle fractures. The customized plates are created based on each patient's CT-derived anatomical morphology, allowing the surgical team to perform virtual planning, simulate fracture reduction, and generate an accurately fitted plate prior to surgery. The primary objective of the study is to assess the accuracy of anatomical reduction achieved using patient-specific plates and to evaluate short- and medium-term clinical outcomes. All patients are treated using an intraoral surgical approach, with fracture reduction performed according to the preoperative virtual plan. The patient-specific titanium plate is then positioned and fixed without the need for intraoperative plate bending. Clinical outcomes evaluated in this study include postoperative pain, facial edema, maximal mouth opening, sensory recovery of the inferior alveolar nerve, dental occlusion, and wound healing. Radiographic assessment evaluates bone healing, alignment, intergonial distance, and the accuracy of fracture reduction across multiple follow-up intervals. These evaluations aim to determine the stability and precision of the patient-specific fixation method. The study follows patients through standardized follow-up periods, including immediate postoperative assessment, 1-week, 1-month, 3-month, and 6-month evaluations. Data are collected prospectively using unified clinical forms and radiological imaging protocols. All procedures adhere to ethical guidelines, and informed consent is obtained from all participants prior to enrollment. The rationale behind using patient-specific plates is the potential to improve biomechanical stability, reduce operative time, eliminate intraoperative plate bending, and achieve more predictable postoperative outcomes. This study aims to provide evidence on whether CAD/CAM-based customized plates offer measurable advantages over conventional fixation systems in the treatment of mandibular angle fractures.
Interventions
DEVICEPatient-Specific Titanium Plate
A customized titanium fixation plate designed using computer-aided design and manufacturing (CAD/CAM) technology based on preoperative CT data. The plate is fabricated to precisely match the patient's mandibular anatomy and used for open reduction and internal fixation of mandibular angle fractures.
Sponsors
Tanta University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
A single-arm clinical study evaluating the accuracy, stability, and clinical outcomes of patient-specific titanium plates fabricated using CAD/CAM technology for fixation of mandibular angle fractures.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. Patient with displaced mandibular angle fracture indicated for open reducation and internal fixation. 2. Age of patient \> 18 years old .
Exclusion criteria
1- Medically compromised patients with impaired healing ability.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of Fracture Reduction | Immediately and 1 week postoperatively | Accuracy of anatomical reduction will be evaluated by comparing postoperative CBCT scans with preoperative virtual surgical plans using superimposition analysis to measure the deviation between planned and achieved fragment positions. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain Intensity | 1 day, 1 week, and 1 month postoperatively | Pain intensity will be recorded using a Visual Analogue Scale (VAS) ranging from 0 (no pain) to 10 (worst pain). |
| Postoperative Facial Edema | 1 week and 2 weeks postoperatively | Facial swelling will be measured using the Souza JA facial edema scale based on standardized anthropometric landmarks. |
| Occlusal Relationship and Stability | 1 week, 1 month, and 3 months postoperatively | Occlusal stability will be evaluated clinically using the Uglešić occlusion score to assess the degree of alignment and functional contact between opposing teeth |
| Recovery of Inferior Alveolar Nerve Function | 1 week, 1 month, and 3 months postoperatively | Sensory recovery of the lower lip and chin will be assessed using light touch and two-point discrimination tests |
| Radiographic Bone Healing | 3 and 6 months postoperatively | Bone union and callus formation will be assessed radiographically on CBCT images to confirm complete healing and stability at the fracture site. |
Countries
Egypt
Outcome results
None listed