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

NCT07001826 | Recruiting DMC

• 1 other identifier: OMFS 3-3 -15
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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

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); Patient-specific plates (PSPs); 3D superimposition; Patient satisfaction

Outcome Measures

Primary Outcomes (1)

• 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."

  6 months post-surgery

Secondary Outcomes (1)

• To assess the aesthetic outcomes post-treatment, including patient satisfaction

  6 months post-surgery

Study Arms (1)

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.

Procedure: Virtual Surgical Planning (VSP) with Patient-Specific Plates (PSPs)

Interventions

Virtual Surgical Planning (VSP) with Patient-Specific Plates (PSPs) PROCEDURE

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.

VSP with Patient-Specific Plates

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years
• Presence of maxillary cant
• Presence of facial asymmetry

You may not qualify if:

• Diagnosis of craniofacial syndrome
• History of maxillofacial tumors
• History of facial trauma
• Presence of cleft lip and/or palate

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry, Cairo University

Cairo, 11562, Egypt

RECRUITING

MeSH Terms

Conditions

Facial Asymmetry; Patient Satisfaction

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• abdulqadr M al-hawaagi, M.Sc.

  CARIO

  PRINCIPAL INVESTIGATOR

Central Study Contacts

abdulqadr M al-hawaagi, M.Sc.

CONTACT

+201092265426; abdulqader.alhawaagi@dentistry.cu.edu.eg

Mohamed A Shehab, Prof

CONTACT

+20 111 224 2421

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Candidate, Department of Oral and Maxillofacial Surgery

Study Record Dates

• First Submitted: May 14, 2025
• First Posted: June 3, 2025
• Study Start: January 1, 2025
• Primary Completion: January 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: June 11, 2025

Record last verified: 2025-06

Locations

EG (1)