Assessment of the Accuracy of Patient Specific Plates for Correction of Maxillary Cant in Facial Asymmetry
- Conditions
- Facial Asymmetry
- Registration Number
- NCT07001826
- Lead Sponsor
- Cairo University
- Brief Summary
This prospective clinical trial evaluates the accuracy of patient-specific plates (PSPs) designed through virtual surgical planning (VSP) for correcting maxillary cant in patients with facial asymmetry. Eight patients will undergo orthognathic surgery using 3D-printed custom plates. The study compares preoperative virtual plans with postoperative outcomes using 3D superimposition to assess surgical accuracy and aesthetic improvement, including patient satisfaction.
- Detailed Description
This prospective clinical trial aims to assess the accuracy and effectiveness of patient-specific plates (PSPs) created through virtual surgical planning (VSP) in the correction of maxillary cant in patients with facial asymmetry. Traditional surgical approaches for correcting facial asymmetry rely on standard plates and manual techniques, which can be less precise and more dependent on the surgeon's experience. This study introduces an advanced, individualized approach utilizing 3D imaging, computer-aided design (CAD), and additive manufacturing to create custom-fit plates tailored to each patient's anatomy.
A total of eight patients diagnosed with maxillary cant and facial asymmetry will be recruited from the Oral and Maxillofacial Surgery and Orthodontics departments at Cairo University. Virtual surgical plans will be developed using high-resolution CT scans and specialized software to simulate osteotomies and plate placement. These plans will guide the design and 3D printing of PSPs and surgical guides, ensuring a high degree of accuracy during the actual procedure.
Primary outcomes will be evaluated by comparing the preoperative virtual plans with postoperative results through 3D model superimposition, measuring discrepancies in millimeters. Secondary outcomes will focus on aesthetic improvements and patient satisfaction. Follow-up will extend for six months post-surgery to assess the stability and success of the surgical outcomes.
This study seeks to provide evidence supporting the use of VSP and PSPs as a reliable, precise alternative to traditional methods for correcting maxillary cant, potentially enhancing both functional and aesthetic results in orthognathic surgery.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 8
Age > 18 years
Presence of maxillary cant
Presence of facial asymmetry
Diagnosis of craniofacial syndrome
History of maxillofacial tumors
History of facial trauma
Presence of cleft lip and/or palate
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method 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."
- Secondary Outcome Measures
Name Time Method To assess the aesthetic outcomes post-treatment, including patient satisfaction 6 months post-surgery Assessment of patient satisfaction using a Likert-scale-based questionnaire evaluating perceived aesthetic and functional improvement.
Trial Locations
- Locations (1)
Faculty of Dentistry, Cairo University
🇪🇬Cairo, Egypt