An interventional study of Open reduction and Internal fixation of a mandibular body fracture and Open reduction and Internal fixation of a mandibular body fracture in Mandibular Fractures, sponsored by Cairo University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2026-10-29.
Sponsored by Cairo University · Not applicable, Interventional, and Treatment
The goal of this randomized controlled clinical trial is to evaluate and compare the bone mineral density (BMD) recovery following open reduction and internal fixation (ORIF) of mandibular body fractures using patient-specific plates versus conventional plates. Bone density at the fracture site will be quantified using Hounsfield Units (HU) on computed tomography (CT) scans.
The main question it aims to answer is: Do patient-specific plates provide a superior recovery of bone mineral density at the fracture site compared to conventional plates in patients undergoing fixation for mandibular body fractures?
This parallel-group, randomized controlled clinical trial evaluates the efficacy of patient-specific (custom-designed) fixation plates compared to conventional plates regarding bone mineral density recovery in mandibular body fractures.
Upon consenting to participate, eligible patients requiring open reduction and internal fixation (ORIF) for mandibular body fractures will be randomly assigned to one of two groups:
All surgical procedures will be standardized and performed under general anesthesia by the same surgical team.
Radiological Assessment of Bone Density:
The primary outcome, bone mineral density recovery at the fracture site, will be analyzed using Hounsfield Units (HU). Patients will undergo multi-slice CT scanning at baseline (within 1 week) and at 6 months postoperatively to assess the recovery.
91 studies on the registry are indexed under Mandibular Fractures; 24 are open to participants now.
This study's planned enrollment of 26 is above the median of 21 across 72 interventional studies indexed under Mandibular Fractures.
Browse Mandibular Fractures studies →Cairo University is the lead sponsor of 4,941 studies on the registry; 1,458 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients in this group will undergo open reduction and internal fixation (ORIF) using custom-designed titanium plates. The plates are pre-fabricated utilizing computer-aided design and computer-aided manufacturing (CAD/CAM) based on the patient's preoperative 3D computed tomography (CT) data.
Procedure: Open reduction and Internal fixation of a mandibular body fracture
Patients in this group will undergo standard open reduction and internal fixation (ORIF) using commercially available, standard stock titanium plates.
Procedure: Open reduction and Internal fixation of a mandibular body fracture
Patient-Specific titanium plates designed using virtual 3D planning software and fabricated via computer-aided manufacturing to match the patient's precise pre-injury mandibular anatomy.
Commercially available, standard stock titanium plates will be adapted and bent manually by the surgeon during the operation to fit the patient's mandibular anatomy.
Bone density
Bone mineral density recovery at the fracture site, will be analyzed using Hounsfield Units (HU).
Time frame: Patients will undergo multi-slice CT scanning at baseline (within 1 week) and at 6 months postoperatively to assess the recovery.
Postoperative occlusion
Number of participants achieving a satisfactory occlusion, defined as meeting three criteria simultaneously: dental midline deviation ≤ 1 mm, bilateral normal canine relationship, and bilateral normal molar relationship. Failure in any criterion is classified as unsatisfactory.
Time frame: One week postoperatively
Incidence of Postoperative Neurosensory Dysfunction
The number of participants who develop neurosensory dysfunction. Sensation is evaluated using the Two-Point Discrimination (2PD) test. Neurosensory dysfunction is defined as a binary categorical outcome where a participant fails to distinguish two distinct points at the standard clinical threshold (≤ 5 mm). Participants who require a distance greater than 5 mm to discriminate the two points are marked as having neurosensory dysfunction.
Time frame: One week postoperatively
Started Oct 2026 (actual). Primary completion is estimated for Nov 2027, 13 months after the start.
Of 38 non-industry interventional studies with no phase under Mandibular Fractures, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 24. This study's planned 13 months is close to that.
Counting every sponsor, half of 38 studies reached it within 13 months; a quarter within 9 and three quarters within 24.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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