Assessment of the Accuracy of Patient Specific Plates for Correction of Maxillary Cant in Facial Asymmetry

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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 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

Eligibility

Primary outcome measure(s)

• 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. — 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."

Trial sites (1)

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