Facial FracturesNCT07920445
A Study Comparing The Functional And Esthetic Outcomes Of Patients Undergoing Corrective Surgery For Old Facial Fractures That Have Healed in the Wrong Position, Using Computer-Based 3D Virtual Surgical Planning Versus Conventional Planning.
A study testing Panfacial Fracture Reduction and Fixation and Panfacial Fracture Reduction and Fixation Using Pre-bent Plates Guided by Virtual Surgical Planning in people with Facial Fractures and Maxillofacial Trauma, run by University of Health Sciences Lahore at 1 site in Pakistan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 15 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Facial Fractures, Maxillofacial Trauma, Malunited Maxilla Fracture
- What is being tested?
- Panfacial Fracture Reduction and Fixation and Panfacial Fracture Reduction and Fixation Using Pre-bent Plates Guided by Virtual Surgical Planning
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePakistan
- Study dates
- 13 Sep 2022to 31 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 50 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Patients with panfacial fractures at least simultaneously involving zygomatic complex, maxilla and mandible. Nasorbitoethmoidal complex and frontal bone may be or may not be involved.
- At least one segment of all three bone should be displaced or comminuted.
- Patients receiving late treatment at least after 6 weeks of trauma.
- ASA class I, otherwise healthy, non-immunocompromised patients of 15 to 50 years of age.
- Patients of both genders.
- Patients willing to participate in study
Who cannot join
- Patients who are immunocompromised
- Patients who have bilateral orbital fractures.
- Patients. having systemic diseases which can affect bone quality e.g. arthritis, chronic kidney diseases, osteoporosis, hyperthyroidism, hyperparathyroidism etc.
- Patients receiving early treatment.
- Patients not willing to participate in study.
- Patients with Bald or receded hair lines -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Functional And Esthetic Outcomes Of Virtual Surgical Planning Vs Conventional Planning In Treatment Of Old Malunited Panfacial Fractures: A Randomized Controlled Trial.
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:
- Does using computer-based 3D virtual planning before surgery lead to better facial functions, facial appearance, and quality of life than traditional surgical planning in patients whose severe facial fractures have healed in the wrong position?
- Does computer-based 3D planning help reduce the time needed to perform surgery compared with traditional planning?
- How often do metal plates that are shaped in advance using computer-based planning need further adjustment during surgery to fit the patient's facial bones correctly?
Read the detailed description
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.
- Being tested
- Panfacial Fracture Reduction and Fixation, Panfacial Fracture Reduction and Fixation Using Pre-bent Plates Guided by Virtual Surgical Planning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Panfacial Fracture Reduction and FixationProcedure or surgery
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
Panfacial Fracture Reduction and Fixation Using Pre-bent Plates Guided by Virtual Surgical PlanningProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Preoperative Virtual Surgical Planning | Experimental | 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. Receives: Procedure: Panfacial Fracture Reduction and Fixation Using Pre-bent Plates Guided by Virtual Surgical Planning |
| Preoperative conventional Planning | Active comparator | Includes Patients to be treated with preoperative conventional planning. Preoperative planning is done using detailed physical examination and CT scan face with 3D reconstruction Receives: Procedure: Panfacial Fracture Reduction and Fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From enrollment to the end of treatment at 12 weeks
Secondary outcomes (5)
Operation time
The time from marking the first incision till placement of final dressing after closure.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: During Intervention (surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2026
- Study start13 Sep 2022
- Primary completion6 Jun 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Facial FracturesStudies of the same condition, open and under way.
- More trials run by University of Health Sciences LahoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Health Sciences Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hurera Pervez, Allama Iqbal Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07920445
- Sponsor's protocol ID
- 146/14/10/2021/S2 ERB.
- Status last verified
- Aug 2023
- First submitted
- 30 Oct 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Thakker JS, Pace M, Lowe I, Jung P, Herford AS. Virtual Surgical Planning in Maxillofacial Trauma. Atlas Oral Maxillofac Surg Clin North Am. 2019 Sep;27(2):143-155. doi: 10.1016/j.cxom.2019.05.006. Epub 2019 Jun 22. No abstract available.
PubMed 31345490Abouchadi, Abdeljalil & Taoufik, Hind & Nacir, Oussama & Adil, Arrob. (2018). Pan-Facial Fractures: A Retrospective Study and Review of Literature. Open Journal of Stomatology. 08. 110-119. 10.4236/ojst.2018.84010.
Alwala, Aditya Mohan & Malyala, Santosh. (2016). Surgical Planning in Pan Facial Trauma Using Additive Manufacturing Medical Model-A Case Study. Jurnalul de Chirurgie. 12. 10.7438/1584-9341-12-3-8.
He D, Zhang Y, Ellis E 3rd. Panfacial fractures: analysis of 33 cases treated late. J Oral Maxillofac Surg. 2007 Dec;65(12):2459-65. doi: 10.1016/j.joms.2007.06.625.
PubMed 18022469
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional And Esthetic Outcomes Of Virtual Surgical Planning Vs Conventional Planning In Treatment Of Old Malunited Panfacial Fractures: A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT07920445
- Acronym / sponsor ID
- 146/14/10/2021/S2 ERB.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of Health Sciences LahoreUniversity, hospital or other
- Study start
- 13 Sep 2022 (actual)
- Primary completion
- 6 Jun 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 5 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does using computer-based 3D virtual planning before surgery lead to better facial functions, facial appearance, and quality of life than traditional surgical planning in patients whose severe facial fractures have healed in the wrong position?
- Does computer-based 3D planning help reduce the time needed to perform surgery compared with traditional planning?
- How often do metal plates that are shaped in advance using computer-based planning need further adjustment during surgery to fit the patient's facial bones correctly?
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preoperative Virtual Surgical Planning | Experimental | Procedure: Panfacial Fracture Reduction and Fixation Using Pre-bent Plates Guided by Virtual Surgical PlanningIncludes 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. |
| Preoperative conventional Planning | Active comparator | Procedure: Panfacial Fracture Reduction and FixationIncludes Patients to be treated with preoperative conventional planning. Preoperative planning is done using detailed physical examination and CT scan face with 3D reconstruction |
Who may qualify
- Ages
- 15 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Patients with panfacial fractures at least simultaneously involving zygomatic complex, maxilla and mandible. Nasorbitoethmoidal complex and frontal bone may be or may not be involved.
- At least one segment of all three bone should be displaced or comminuted.
- Patients receiving late treatment at least after 6 weeks of trauma.
- ASA class I, otherwise healthy, non-immunocompromised patients of 15 to 50 years of age.
- Patients of both genders.
Key exclusion criteria (6 listed)
- Patients who are immunocompromised
- Patients who have bilateral orbital fractures.
- Patients. having systemic diseases which can affect bone quality e.g. arthritis, chronic kidney diseases, osteoporosis, hyperthyroidism, hyperparathyroidism etc.
- Patients receiving early treatment.
- Patients not willing to participate in study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Panfacial Fracture Reduction and FixationAll 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 | Procedure or surgery | Preoperative conventional Planning |
| Panfacial Fracture Reduction and Fixation Using Pre-bent Plates Guided by Virtual Surgical PlanningAll 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. | Procedure or surgery | Preoperative Virtual Surgical Planning |
Primary outcome
Malocclusion
Time frame: From enrollment to the end of treatment at 12 weeks
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
5 secondary outcomes
Operation time
Time frame: During intervention(surgery)
Enophthalmos
Time frame: From enrollment to the end of treatment at 12 weeks
Anthropometric facial measurements
Time frame: From enrollment to the end of treatment at 12 weeks
Quality of life questionnaire
Time frame: After intervention till the end of treatment at 12 weeks
Number of readjustments of prebent plates
Time frame: During Intervention (surgery)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Background: PubMed 31345490Thakker JS, Pace M, Lowe I, Jung P, Herford AS. Virtual Surgical Planning in Maxillofacial Trauma. Atlas Oral Maxillofac Surg Clin North Am. 2019 Sep;27(2):143-155. doi: 10.1016/j.cxom.2019.05.006. Epub 2019 Jun 22. No abstract available.
- BackgroundAbouchadi, Abdeljalil & Taoufik, Hind & Nacir, Oussama & Adil, Arrob. (2018). Pan-Facial Fractures: A Retrospective Study and Review of Literature. Open Journal of Stomatology. 08. 110-119. 10.4236/ojst.2018.84010.
- BackgroundAlwala, Aditya Mohan & Malyala, Santosh. (2016). Surgical Planning in Pan Facial Trauma Using Additive Manufacturing Medical Model-A Case Study. Jurnalul de Chirurgie. 12. 10.7438/1584-9341-12-3-8.
- Background: PubMed 18022469He D, Zhang Y, Ellis E 3rd. Panfacial fractures: analysis of 33 cases treated late. J Oral Maxillofac Surg. 2007 Dec;65(12):2459-65. doi: 10.1016/j.joms.2007.06.625.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Panfacial Fracture Reduction and Fixation and Panfacial Fracture Reduction and Fixation Using Pre-bent Plates Guided by Virtual Surgical Planning in people with Facial Fractures and Maxillofacial Trauma, run by University of Health Sciences Lahore at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Malocclusion (time frame: From enrollment to the end of treatment at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07920445, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.