An interventional study of Panfacial Fracture Reduction and Fixation and Panfacial Fracture Reduction and Fixation Using Pre-bent Plates Guided by Virtual Surgical Planning in Facial Fractures, Maxillofacial Trauma and Malunited Maxilla Fracture, sponsored by University of Health Sciences Lahore. Completed at 1 site in Pakistan. Open to participants aged 15 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by University of Health Sciences Lahore · Not applicable, Interventional, and Treatment
The purpose of this study is to find out whether using computer-based virtual planning before surgery can improve facial functions and appearance in patients whose severe facial fractures have healed in the wrong position. The study will compare this method with traditional surgical planning. The main questions it aims to answer are:
Panfacial fractures(PFF) are those that affect the upper, middle, and lower faces all at once. PFF are tougher than single fractures to treat. Due to multiple subunits involvement, it is difficult to determine the best treatment plan as there is limited stable framework available to help in anatomic reduction. PFF is usually accompanied by injuries to other systems e.g., neurological, abdominal and chest injuries which could be life threatening and need to be managed immediately. That's why treatment of PFF is often get delayed causing malunion of fractures along with scarring of soft tissue making treatment of these fractures more challenging. There are several other factors responsible for delay in treatment of such complicated fractures specially in third world countries for example lack of facilities, remote location, denial by patients and ignorance of hospital staff to Maxillofacial injuries may cause mismanagement of such injuries.
Conventional preoperative planning for old malunited PFF involves taking a detailed medical history, performing a thorough clinical examination, and reviewing 3D imaging to assess the position of the facial bones and plan corrective surgery. Over the past decade, Virtual Surgical Planning(VSP) has revolutionized the craniomaxillofacial surgery. With the emergence of VSP it is now possible to assess the fracture in multiple plan and design comprehensive treatment plan for complex surgeries. With the help of VSP surgeon can plan surgery preoperatively on computer images and manipulate these images to reduce fractures precisely followed by 3D printing of these images. Miniplates and meshes can be prebent on medical 3D model preoperatively, which can help in proper reduction peroperatively and can also help in saving surgical time.
The VSP could be a major breakthrough for comprehensive preoperative treatment planning and optimizing the outcome in single surgery of old malunited PFF. Studies to establish the role of VSP in PFF are lacking. Therefore, the objective of this study is to determine the role of VSP in reducing operating time and improving functional outcome, esthetic outcome and quality of life in patients with old malunited PFF and also compare it with conventional non computer assisted surgical planning. Reduction in operation time will reduce the ischemia time and better preoperative planning will produce more optimal functional and esthetic outcome avoiding the need for second surgery.
University of Health Sciences Lahore is the lead sponsor of 83 studies on the registry; 52 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Includes Patients to be treated with preoperative virtual surgical planning(VSP). VSP is preoperative planning method that involves the visualization of a surgical procedure using 3D imaging computer software. The imaging data of patients is sent to relevant company for virtual planning in DICOM( (Digital Imaging and Communications in Medicine) format. Manipulation of dataset is done using virtual surgical planning software and after segmentation of bony pieces, precise osteotomy, reduction and mirroring of normal side are planned in a meeting with engineer of relevant company. The final position is saved as individuals files which are used to fabricate a stereolithographic model of skull. Stereolithographic model is created using polylactic acid or resin material. Preoperative bending of plate and meshes are done on this model surgery before surgery.
Procedure: Panfacial Fracture Reduction and Fixation Using Pre-bent Plates Guided by Virtual Surgical Planning
Includes Patients to be treated with preoperative conventional planning. Preoperative planning is done using detailed physical examination and CT scan face with 3D reconstruction
Procedure: Panfacial Fracture Reduction and Fixation
All fracture sites will be exposed, and the fracture segments will be mobilized following osteotomy. Reduction and fixation will then be performed using the bottom-to-top and outside-in approach
All fracture sites will be exposed, and the fracture segments will be mobilized following osteotomy. Reduction and fixation will then be performed using the 'bottom-to-top and outside-in' approach. Preoperatively pre-bent fixation plates and meshes, adapted to stereolithographic models, will be used intraoperatively.
Malocclusion
Deviation from normal occlusion in which teeth are not in their normal relation to the adjacent teeth in the same jaw and to the opposing teeth when the jaw is closed. Post traumatic malocclusion includes anterior open bite, posterior open bite, anterior cross bite, posterior cross bite and, gagging of occlusion. Malocclusion was assessed on clinical examination
Time frame: From enrollment to the end of treatment at 12 weeks
Operation time
The time from marking the first incision till placement of final dressing after closure.
Time frame: During intervention(surgery)
Enophthalmos
Characterized as backward displacement of eyeball. It will be measured on axial slice of CT scan face. A line connecting bilateral anterior tips of lateral walls will be made. After identifying center of cornea, a vertical line perpendicular to first line will be drawn bilaterally. Difference of both perpendicular lines is enophthalmos measurement. Every cm3 increase in volume is represented by approximately 0.77mm.
Time frame: From enrollment to the end of treatment at 12 weeks
Anthropometric facial measurements
Anthropometry is 'study of measurements of human body' and Anthropometric facial measurements are 'linear distances which are measured using anatomical landmarks at predefined locations on face'. It includes Upper facial height ,Middle facial height, Lower facial height, Maximal facial breadth and Bigonal breadth.
Time frame: From enrollment to the end of treatment at 12 weeks
Quality of life questionnaire
A set of survey questions that can be used to collect data related to an individual in particular to determine their general quality of life, health, living condition and more.Questionnaire is based on a validated Dutch questionnaire and it includes questions about isolation from work, social isolation, ability to eat, ability to speak, influence on sleep, facial appearance, and satisfaction with the given treatment
Time frame: After intervention till the end of treatment at 12 weeks
Number of readjustments of prebent plates
Peroperative rebending of already bent plate in patients receiving preoperative virtual surgical planning
Time frame: During Intervention (surgery)
Plan to share: No
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 ↗
This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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University of Health Sciences Lahore