Assessment of the Accuracy of Patient Specific Plates for Correction of Maxillary Cant in Facial Asymmetry
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Virtual Surgical Planning (VSP) with Patient-Specific Plates (PSPs).
- Who it may be relevant to
- Registry conditions: Facial Asymmetry. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Assessment of the Accuracy of Patient Specific Plates for Correction of Maxillary Cant in Facial Asymmetry: A Prospective Clinical Trial
Overview
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.
Interventions
- Procedure 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
Primary outcome measures
- 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]
Secondary outcome measures (1)
- To assess the aesthetic outcomes post-treatment, including patient satisfaction [Time frame: 6 months post-surgery]
Eligibility criteria
Inclusion criteria
Age > 18 years
Presence of maxillary cant
Presence of facial asymmetry
Exclusion criteria
Diagnosis of craniofacial syndrome
History of maxillofacial tumors
History of facial trauma
Presence of cleft lip and/or palate
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Faculty of Dentistry, Cairo University — Cairo
Identifiers
NCT: NCT07001826 · OMFS 3-3 -15