Facial AsymmetryNCT07001826
Assessment of the Accuracy of Patient Specific Plates for Correction of Maxillary Cant in Facial Asymmetry
A study testing Virtual Surgical Planning (VSP) with Patient-Specific Plates (PSPs) in people with Facial Asymmetry, run by Cairo University at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to learn how accurate patient-specific plates (PSPs) are for correcting a tilted upper jaw (maxillary cant) in people with facial asymmetry. The main questions it aims to answer are: How closely does the actual surgery match the virtual surgical plan? How satisfied are participants… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Facial Asymmetry
- What is being tested?
- Virtual Surgical Planning (VSP) with Patient-Specific Plates (PSPs)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2025to 1 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years
- Presence of maxillary cant
- Presence of facial asymmetry
Who cannot join
- Diagnosis of craniofacial syndrome
- History of maxillofacial tumors
- History of facial trauma
- Presence of cleft lip and/or palate
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mohamed A Shehab, Prof contact
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Dentistry, Cairo University
Cairo, 11562
Abdulqader M al-hawaagi, M.Sc., +201092265426, abdulqader.alhawaagi@dentistry.cu.edu.eg
About this study
Official title: Assessment of the Accuracy of Patient Specific Plates for Correction of Maxillary Cant in Facial Asymmetry: A Prospective Clinical Trial
The goal of this clinical trial is to learn how accurate patient-specific plates (PSPs) are for correcting a tilted upper jaw (maxillary cant) in people with facial asymmetry. The main questions it aims to answer are:
- How closely does the actual surgery match the virtual surgical plan?
- How satisfied are participants with how they look after surgery?
Researchers will compare the surgery results using PSPs to the original 3D virtual plan to see how well they match.
Participants will:
- Have a CT scan and 3D virtual surgery planning
- Get custom-made plates designed to fit their upper jaw
- Undergo surgery to correct the tilt of the upper jaw
- Be followed for up to 6 months to check healing and results
Read the detailed description
This prospective clinical trial aims to evaluate the accuracy and efficacy of patient-specific plates (PSPs) created through virtual surgical planning (VSP) for the correction of maxillary cant in patients with facial asymmetry. Facial asymmetry, particularly in the upper third of the face, often presents with occlusal canting that poses both aesthetic and functional challenges. Traditional orthognathic techniques, such as LeFort I osteotomy with standard fixation hardware, often rely heavily on surgeon experience, potentially compromising consistency and precision.
Virtual Surgical Planning and 3D-Printed PSPs introduce a paradigm shift by enabling surgeons to simulate the osteotomy and repositioning process in a digital environment. This planning facilitates the design and fabrication of custom titanium plates and cutting guides precisely tailored to the patient's skeletal anatomy. This trial investigates whether these individualized devices can achieve closer adherence to the preoperative virtual plan, thus improving surgical accuracy and outcomes.
A sample of eight clinical cases will be included, all diagnosed with maxillary cant and facial asymmetry and meeting defined inclusion/exclusion criteria. The intervention involves a multi-step process:
CT Imaging and Data Acquisition: High-resolution scans of each patient's craniofacial skeleton are obtained in DICOM format.
3D Modeling and Segmentation: Specialized software (Mimics, ProPlan, 3-Matic) is used to segment anatomical structures and perform virtual surgical planning.
Design of PSPs and Surgical Guides: Custom plates and cutting guides are generated based on the planned osteotomy and repositioning.
3D Printing and Manufacturing: Plates are fabricated from titanium using milling techniques, while guides are printed with biocompatible resin.
Surgical Execution: The LeFort I osteotomy, combined with BSSO when indicated, is performed using the guides to ensure precise bone cuts and the PSPs for fixation in the planned position.
The primary outcome is the degree of congruence between preoperative virtual plans and postoperative outcomes, assessed through 3D superimposition of CT images at multiple timepoints (1 week, 1 month, 3 months, and 6 months). Secondary outcomes include aesthetic evaluation and patient satisfaction.
Postoperative care involves standardized antibiotic, analgesic, and steroid regimens, with structured follow-up. Accuracy is quantified in millimeters using reproducible anatomical landmarks. Data will be analyzed using appropriate parametric or nonparametric tests, depending on distribution.
This study addresses a critical gap in the literature by focusing specifically on the role of PSPs in correcting maxillary cant-a feature of asymmetry often overlooked in prior research. The results are expected to contribute evidence-based insights into improving surgical precision, enhancing patient-specific outcomes, and possibly minimizing intraoperative time and postoperative complications.
- Conditions
- Facial Asymmetry
- Being tested
- Virtual Surgical Planning (VSP) with Patient-Specific Plates (PSPs)
- Keywords
- High-resolution CT scans, Computer-aided design (CAD), Virtual surgical planning (VSP), Orthognathic surgery, Asymmetrical mandibular deformities, Maxillary cant, LeFort I osteotomy, Bilateral sagittal split osteotomy (BSSO), Patient-specific plates (PSPs), 3D superimposition, Patient satisfaction
- Medical subject headings
- Facial Asymmetry, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Surgical Planning (VSP) with Patient-Specific Plates (PSPs)Procedure or surgery
Patients will undergo orthognathic surgery using Virtual Surgical Planning (VSP) combined with custom-fabricated Patient-Specific Plates (PSPs). High-resolution CT scans will be used to create 3D models of each patient's craniofacial structure. Surgical plans will be developed using specialized CAD software, and PSPs will be designed and manufactured using 3D printing and milling techniques. During surgery, these custom plates and accompanying cutting guides will be used to accurately reposition the maxilla, ensuring precise correction of maxillary cant. This approach aims to improve surgical accuracy, reduce operating time, and enhance postoperative outcomes.
| Study group | Role | What they receive |
|---|---|---|
| VSP with Patient-Specific Plates | Experimental | Participants in this arm will undergo orthognathic surgery for correction of maxillary cant using Virtual Surgical Planning (VSP) and custom-designed Patient-Specific Plates (PSPs). The procedure includes preoperative 3D imaging, virtual planning, 3D-printed surgical guides, and personalized fixation plates for precise bone repositioning. Receives: Procedure: Virtual Surgical Planning (VSP) with Patient-Specific Plates (PSPs) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare pre-operative virtual surgical planning data with post-operative outcomes to measure the correlation between planned and actual surgical results through superimposing of post with planned.
performed by superimposing the planned 3D model onto the postoperative 3D model, typically by selecting three or more points to create a plane on the planned model. These same points are then used on the corresponding postoperative model, allowing for an accurate comparison. This method is useful for detecting the accuracy of planning, particularly in assessing pitch and roll movements.
The accuracy was evaluated using linear measurements (in millimeters), based on specific reproducible points identified on the 3D preoperative casts and compared with the 3D postoperative casts."
Measured: 6 months post-surgery
Secondary outcomes (1)
To assess the aesthetic outcomes post-treatment, including patient satisfaction
Assessment of patient satisfaction using a Likert-scale-based questionnaire evaluating perceived aesthetic and functional improvement.
Measured: 6 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2025
- Study start1 Jan 2025
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Facial AsymmetryStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdulqader Mohammed Ali Al-hawaagi, Cairo University
- Investigators
- abdulqadr M al-hawaagi, M.Sc., Principal investigator, CARIO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07001826
- Sponsor's protocol ID
- OMFS 3-3 -15
- Status last verified
- Jun 2025
- First submitted
- 14 May 2025
- Last updated
- 11 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Accuracy of Patient Specific Plates for Correction of Maxillary Cant in Facial Asymmetry: A Prospective Clinical Trial
- ClinicalTrials.gov ID
- NCT07001826
- Acronym / sponsor ID
- OMFS 3-3 -15
- Conditions
- Facial Asymmetry
- Keywords
- High-resolution CT scans, Computer-aided design (CAD), Virtual surgical planning (VSP), Orthognathic surgery, Asymmetrical mandibular deformities, Maxillary cant, LeFort I osteotomy, Bilateral sagittal split osteotomy (BSSO)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 3 Jun 2025 (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 goal of this clinical trial is to learn how accurate patient-specific plates (PSPs) are for correcting a tilted upper jaw (maxillary cant) in people with facial asymmetry. The main questions it aims to answer are:
- How closely does the actual surgery match the virtual surgical plan?
- How satisfied are participants with how they look after surgery?
Researchers will compare the surgery results using PSPs to the original 3D virtual plan to see how well they match.
Participants will:
- Have a CT scan and 3D virtual surgery planning
- Get custom-made plates designed to fit their upper jaw
- Undergo surgery to correct the tilt of the upper jaw
- Be followed for up to 6 months to check healing and results
Detailed description
This prospective clinical trial aims to evaluate the accuracy and efficacy of patient-specific plates (PSPs) created through virtual surgical planning (VSP) for the correction of maxillary cant in patients with facial asymmetry. Facial asymmetry, particularly in the upper third of the face, often presents with occlusal canting that poses both aesthetic and functional challenges. Traditional orthognathic techniques, such as LeFort I osteotomy with standard fixation hardware, often rely heavily on surgeon experience, potentially compromising consistency and precision.
Virtual Surgical Planning and 3D-Printed PSPs introduce a paradigm shift by enabling surgeons to simulate the osteotomy and repositioning process in a digital environment. This planning facilitates the design and fabrication of custom titanium plates and cutting guides precisely tailored to the patient's skeletal anatomy. This trial investigates whether these individualized devices can achieve closer adherence to the preoperative virtual plan, thus improving surgical accuracy and outcomes.
A sample of eight clinical cases will be included, all diagnosed with maxillary cant and facial asymmetry and meeting defined inclusion/exclusion criteria. The intervention involves a multi-step process:
CT Imaging and Data Acquisition: High-resolution scans of each patient's craniofacial skeleton are obtained in DICOM format.
3D Modeling and Segmentation: Specialized software (Mimics, ProPlan, 3-Matic) is used to segment anatomical structures and perform virtual surgical planning.
Design of PSPs and Surgical Guides: Custom plates and cutting guides are generated based on the planned osteotomy and repositioning.
3D Printing and Manufacturing: Plates are fabricated from titanium using milling techniques, while guides are printed with biocompatible resin.
Surgical Execution: The LeFort I osteotomy, combined with BSSO when indicated, is performed using the guides to ensure precise bone cuts and the PSPs for fixation in the planned position.
The primary outcome is the degree of congruence between preoperative virtual plans and postoperative outcomes, assessed through 3D superimposition of CT images at multiple timepoints (1 week, 1 month, 3 months, and 6 months). Secondary outcomes include aesthetic evaluation and patient satisfaction.
Postoperative care involves standardized antibiotic, analgesic, and steroid regimens, with structured follow-up. Accuracy is quantified in millimeters using reproducible anatomical landmarks. Data will be analyzed using appropriate parametric or nonparametric tests, depending on distribution.
This study addresses a critical gap in the literature by focusing specifically on the role of PSPs in correcting maxillary cant-a feature of asymmetry often overlooked in prior research. The results are expected to contribute evidence-based insights into improving surgical precision, enhancing patient-specific outcomes, and possibly minimizing intraoperative time and postoperative complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VSP with Patient-Specific Plates | Experimental | Procedure: Virtual Surgical Planning (VSP) with Patient-Specific Plates (PSPs)Participants in this arm will undergo orthognathic surgery for correction of maxillary cant using Virtual Surgical Planning (VSP) and custom-designed Patient-Specific Plates (PSPs). The procedure includes preoperative 3D imaging, virtual planning, 3D-printed surgical guides, and personalized fixation plates for precise bone repositioning. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age > 18 years
- Presence of maxillary cant
- Presence of facial asymmetry
Key exclusion criteria (4 listed)
- Diagnosis of craniofacial syndrome
- History of maxillofacial tumors
- History of facial trauma
- Presence of cleft lip and/or palate
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 |
|---|---|---|
| Virtual Surgical Planning (VSP) with Patient-Specific Plates (PSPs)Patients will undergo orthognathic surgery using Virtual Surgical Planning (VSP) combined with custom-fabricated Patient-Specific Plates (PSPs). High-resolution CT scans will be used to create 3D models of each patient's craniofacial structure. Surgical plans will be developed using specialized CAD software, and PSPs will be designed and manufactured using 3D printing and milling techniques. During surgery, these custom plates and accompanying cutting guides will be used to accurately reposition the maxilla, ensuring precise correction of maxillary cant. This approach aims to improve surgical accuracy, reduce operating time, and enhance postoperative outcomes. | Procedure or surgery | VSP with Patient-Specific Plates |
Primary outcome
To compare pre-operative virtual surgical planning data with post-operative outcomes to measure the correlation between planned and actual surgical results through superimposing of post with planned.
Time frame: 6 months post-surgery
performed by superimposing the planned 3D model onto the postoperative 3D model, typically by selecting three or more points to create a plane on the planned model. These same points are then used on the corresponding postoperative model, allowing for an accurate comparison. This method is useful for detecting the accuracy of planning, particularly in assessing pitch and roll movements. The accuracy was evaluated using linear measurements (in millimeters), based on specific reproducible points identified on the 3D preoperative casts and compared with the 3D postoperative casts."
1 secondary outcome
To assess the aesthetic outcomes post-treatment, including patient satisfaction
Time frame: 6 months post-surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2025.
Related trials for Facial Asymmetry
RecruitingObservational study
Driving Time and Facial Skin Hydration Asymmetry in Florida Drivers
Skin Diseases, Photoaging
Recruiting
Treatment for "Asymmetric Crying Facies"
Hemifacial Microsomia, Facial Nerve Paralysis
Recruiting
Combined Effects of Proprioceptive Neuromuscular Facilitation (PNF) and Neural Mobilization on Improving Facial Symmetry in Patients With Bells Palsy
Bell's Palsy, Facial Paralysis
RecruitingPhase 4
Evaluation of Filler Injection for Chin Profile Enhancement
Chin Regression, Chin Asymmetry
Recruiting
Clinical Evaluation of Patient-Specific 3D-Printed Titanium Implants for Facial Reconstruction.
Hemifacial Microsomia, Mucormycosis
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.
Mohamed A Shehab, Prof contact
abdulqadr M al-hawaagi, M.Sc. principal investigator
CARIO
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Surgical Planning (VSP) with Patient-Specific Plates (PSPs) in people with Facial Asymmetry, run by Cairo University at 1 site in Egypt.
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 3 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 11 Jun 2025. 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 Egypt. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact abdulqadr M al-hawaagi, M.Sc. (+201092265426, abdulqader.alhawaagi@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare pre-operative virtual surgical planning data with post-operative outcomes to measure the correlation between planned and actual surgical results through superimposing of post with planned. (time frame: 6 months post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Jun 2025.