Clinical Research Directory

Optimized Osteosynthesis: Bone Mineral Density Recovery in Mandibular Body Fractures Using Patient-Specific Versus Conventional Plates

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?

Z-Shaped Versus Conventional Miniplates for Mandibular Fractures

This study compares two different methods of repairing fractures at the front of the lower jaw (the symphysis and parasymphysis). Usually, surgeons fix these displaced fractures using two separate titanium plates, which can be time-consuming to place and lie close to the nerve that supplies feeling to the lower lip and chin. Recently, a single Z-shaped titanium plate was designed to provide the same stability using less hardware, potentially making the surgery easier and safer for the nerve. The purpose of this study is to compare the use of a single Z-shaped miniplate with the conventional two-miniplate technique in adult patients. The researchers will measure how long the surgery takes, the number of screws needed, and how easy it is to place the plates. After the surgery, patients will be monitored for up to 3 months to compare pain levels, facial swelling, jaw movement (mouth opening and side-to-side movement), nerve function, and how well the bone heals on x-rays.

Custom-Made Titanium Plates Versus Custom-Made Polyether Ether Ketone (PEEK) Plates

Mandibular fractures represent a significant portion of maxillofacial trauma, primarily resulting from motor vehicle accidents, interpersonal violence, and sports-related injuries. Achieving successful treatment requires accurate anatomical reduction, stable internal fixation, and restoration of pre-traumatic occlusion and masticatory function . Open reduction and internal fixation (ORIF) using titanium miniplates has long served as the gold standard for mandibular fracture management due to their superior mechanical strength, excellent biocompatibility, and proven structural reliability . Despite their widespread clinical adoption, conventional titanium plates present notable drawbacks. Their high elastic modulus compared to human cortical bone often leads to stress shielding, which can impede normal bone healing and cause local osteopenia .Additionally, titanium hardware can cause temperature sensitivity, scatter artifacts on computed tomography (CT) and magnetic resonance imaging (MRI) scans, and may necessitate secondary surgical removal due to palpability or infection . To address these limitations, Polyether Ether Ketone (PEEK)-a high-performance thermoplastic polymer has emerged as a promising alternative biomaterial in maxillofacial surgery. PEEK exhibits an elastic modulus close to natural bone, thereby reducing stress shielding and promoting physiological strain distribution during fracture healing. Furthermore, PEEK is radiolucent, non-magnetic, and chemically inert, allowing artifact-free postoperative radiologic assessment . With advancements in digital dentistry, computer-aided design and computer-aided manufacturing (CAD/CAM) alongside 3D printing have enabled the fabrication of patient-specific, custom-made implants. Custom-made titanium and PEEK plates eliminate the need for intraoperative manual bending, significantly reducing surgical time, improving contour accuracy, and enhancing mechanical stability across the fracture site . While custom-made titanium provides rigid fixation suitable for high-load zones, custom-made PEEK implants offer an biomechanically compatible and artifact-free alternative. However, direct comparative clinical and biomechanical evaluations between custom-made titanium and custom-made PEEK plates for mandibular fracture fixation remain limited. Therefore, this study aimed to evaluate and compare the clinical outcome, stability, and surgical efficiency of custom-made titanium versus custom-made PEEK plates in the fixation of mandibular fractures.

Virtual Surgical Planning and Preoperative Plate Bending for Maxillofacial Fractures

Purpose: Complex mandibular fractures are commonly associated with high-energy maxillofacial trauma and may result in disruption of mandibular continuity, facial deformity, malocclusion, and impaired mastication and speech. Surgical management is challenging because comminuted or displaced bone fragments can obscure normal anatomical landmarks and make accurate restoration of mandibular anatomy difficult. Although reconstruction plates provide stable fixation, conventional intraoperative plate bending is technically demanding and may contribute to inaccurate plate adaptation, condylar malposition, facial asymmetry, or prolonged operative time. This study aims to evaluate the effectiveness of Virtual Surgical Planning (VSP) combined with three-dimensional (3D) printing and preoperative reconstruction plate bending compared with conventional surgery in patients with complex mandibular fractures requiring reconstruction plate fixation. Method: This study is designed as a randomized controlled clinical trial involving patients with maxillofacial trauma diagnosed with complex mandibular fractures, with or without associated maxillofacial fractures, who are indicated for open reduction and internal fixation using reconstruction plates. The study will be conducted at the National Hospital of Odonto-Stomatology in Ho Chi Minh City and the University Medical Center Ho Chi Minh City from August 2026 to August 2028. Eligible participants will be randomly allocated to two groups. The Virtual Surgery Group will undergo preoperative computed tomography (CT)-based virtual fracture reduction, followed by fabrication of a patient-specific 3D-printed mandibular model and preoperative bending of the reconstruction plate according to the virtually restored mandibular anatomy. The Conventional Surgery Group will undergo standard open reduction and internal fixation with reconstruction plate adaptation and bending performed intraoperatively. Data collection will include preoperative clinical and radiographic characteristics, operative parameters, and postoperative clinical and radiographic outcomes. Postoperative imaging will be used to assess the accuracy of mandibular reduction and restoration of anatomical relationships. Operative time and early postoperative outcomes, including pain and swelling, will also be compared between the two treatment approaches. Expected Results: The investigators anticipate that VSP combined with 3D printing and preoperative reconstruction plate bending will provide greater accuracy in restoring mandibular anatomy compared with conventional surgery. Improved preoperative planning and plate adaptation are expected to reduce the need for intraoperative plate adjustment, shorten operative time, and decrease postoperative swelling and pain. The approach may also improve restoration of mandibular symmetry, occlusion, and condylar position. Conclusions: If this study demonstrates that VSP, 3D printing, and preoperative reconstruction plate bending provide greater surgical accuracy and improved perioperative outcomes compared with conventional techniques, these findings could support their broader application in the management of complex mandibular fractures. This approach may provide oral and maxillofacial surgeons with a more precise and efficient method for restoring mandibular anatomy, while reducing operative burden and early postoperative morbidity in patients with complex maxillofacial trauma.

Epidemiological and Statistical Study of Facial Traumatic Fractures at Assiut University Trauma Hospital

Facial traumatic fractures represent a significant global and regional health burden that can impair essential functions such as breathing, speaking, and chewing, while carrying substantial functional and psychological consequences. The purpose of this study is to evaluate the epidemiological characteristics, causes, anatomical patterns, and clinical outcomes of facial traumatic fractures among patients presenting to the Trauma Hospital of Assiut University Hospitals between January 2025 and December 2028. In this observational study, researchers will systematically extract and review data from emergency admission records, hospital registries, and radiological archives. The collected data will include participant demographics (such as age, sex, residence, and occupation), the primary mechanism of trauma (such as road traffic accidents, falls, and assaults), the use of protective gear (such as seatbelts and helmets), and time intervals before hospital presentation. Imaging studies, including computed tomography (CT) and plain radiographs, will be analyzed to record the specific fracture sites, laterality, and injury complexity. The study will also document concomitant injuries across other body systems, the treatment modalities administered (conservative management versus surgical fixation), post-treatment complications, and length of hospital stay. The findings will help characterize current trauma trends in Upper Egypt to inform injury prevention strategies and assist in hospital resource allocation for maxillofacial trauma care.

Erich Arch Bars, IMF Screws and Hybrid Arch Bars in the Management of Mandibular Fractures

Treatment options of mandibular fractures can be accomplished with either closed treatment or open reduction internal fixation (ORIF). Maxillomandibular fixation (MMF) refers to any method used to secure the maxilla and mandible in proper dental occlusion. MMF is a standard component of mandibular fracture management essential for closed treatment and commonly used du ring ORIF. Its three main principles are to establish occlusion, provide stability, and immobilize the jaws.

Safety-zone Approach and Facial Nerve Preservation in Transbuccal-accessed Fixation of Mandibular Fractures

The goal of this study is to investigate the efficacy of a safety-zone that is anatomically landmarked on the face of patients with mandibular fractures that are approached transbuccally (through cheek) on postoperative intactness of facial nerve.

Evaluation of Pin Buckle Bone Plates for Management of Anterior Mandibular Fractures

This randomized clinical study aims to evaluate the clinical and radiographic outcomes of a novel Pin Buckle bone plate compared with conventional two-miniplate fixation for the management of anterior mandibular (symphysis and parasymphysis) fractures. Twenty adult patients requiring open reduction and internal fixation will be randomly allocated into two equal groups. The study group will receive fixation using the Pin Buckle bone plate, while the control group will be treated using conventional titanium miniplates. Clinical outcomes including pain, edema, wound healing, and postoperative complications will be evaluated during the postoperative follow-up period. Radiographic assessment using computed tomography (CT) will be performed immediately after surgery and at 6 months to evaluate bone density. The study seeks to determine whether the Pin Buckle bone plate provides improved postoperative healing and functional outcomes compared with conventional miniplate fixation.

Facial iD Customized Mandible Reconstruction Plates

A retrospective post market follow up to confirm the safety and performance of Stryker's Customized Plates for Mandibular Reconstruction. The study is performed to confirm the product's performance and safety by systematically collecting clinical data on its use.

Stryker Facial iD Universal Plate Configurator: A Retrospective Post Market Follow Up

A retrospective post market follow up to confirm safety and performance of Stryker's Facial iD Universal Plate Configurator (UPC) implants in the clinical setting. The study is performed to confirm the product's performance and safety by systematically collecting clinical data on its use.

CAD/CAM Angle Fracture Reduction/Plate Guide and Customized 3D Grid Plate Versus Champy's Technique

This proposed study aims at creating a computer designed patient specific device and titanium plates, that are 3D manufactured in accordance to a preoperative computer aided virtual surgical procedure, aiming to obtain proper alignment of fractured segments of the lower jaw and restore proper teeth positioning therefore overcoming the possible complications of the conventional methods. Recruited participants will be randomly allocated to a treatment groupp, whether the novel method group or a standard treatment group. Preoperative panoramic radiograph and a Computed tomography scan will be obtained for each patient. Surgical procedure will be conducted unde general anesthetic. Medications will be prescribed after surgery and instructions will be given to each patient. Follow up will be on a weekly basis for the first 6 weeks followed by a followup visit once a month for 6 months. Postoperative panoramic radiograph and a Computed tomography scan will be obtained at 1 week after the surgical procrdure and again 6 months later. Digital data obtained from computed tomography scans along with clinical data will be analysed and studied to determine the accuracy of the computer aided device and for comparison with the standard method of treatment.

Validity of Computed Guided Technology in Proper Placement of Intermaxillary Fixation Screws in Mandibular Fractures

A randomized clinical study that aims to assess the validity of the use of computer guided technique in the proper placement of IMF screws in mandibular fractures

Approaches for Open Reduction and Internal Fixation of Mandibular Condylar Fracture

The condylar region is the most frequent anatomical site for mandibular fractures . Condylar fractures constitute 25.5% to 35.5% of all mandibular fractures. The mandibular condyle fracture is a type of fracture that affects the condyle, which is the knuckle-like projection of the mandible (lower jaw) that articulates with the temporal bone to form the temporomandibular joint (TMJ).

Fracture Pattern Following Bilateral Sagittal Split Osteotomy With or Without Impacted Third Molars

The goal of this clinical trial is to investigate the hypothesis that there are none difference in the treatment result of orthognathic surgery on the lower jaw, with interoperative wisdom tooth removal rather than preoperative wisdom tooth removal. In patients with severe dental malocclusion combined with a dentofacial deformity. The main question it aims to answer are: • Is there a difference in the degree of complication and the patient's perception, with inter-operative wisdom tooth removal rather than pre-operative wisdom tooth removal. Participants will be will be divided into two groups, with one group having their wisdom teeth removed 6 months before their jaw moving surgery and the other group having their wisdom teeth removed in connection with their jaw moving surgery.