NCT Number: NCT07153354
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.
Trial opening soon.
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Interventional
Not applicable
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
The fixation will be performed according to established surgical principles for managing class iv mandibular fractures, without patient-specific planning
Time frame: 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.
Time frame: 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)
Time frame: During the surgery
Total duration from skin incision to wound closure, recorded intraoperatively.
Contact information is provided by the study sponsor or research team.
Mohamed abdelsalam Gaber elkhouly
Other
Precision of Patient-specific Screw Holes Locating Surgical Guide and Pre-bent Plates Osteosynthesis Versus Classical Workflow in the Management of Class IV Mandibular Fractures
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
