NCT07222904

Evaluation of the Accuracy of Patient Specific Implant in Fixation of Mandibular Sagittal Split Osteotomy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Faculty of Dental Medicine for Girls · Other Government
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

Study was Conducted on Patients were need BSSO Using PSI for reposition and fixation

Detailed description

A prospective study was conducted, and it included 8 patients. All patients underwent mandibular sagittal split osteotomy (BSSO) using PSI for repositioning and fixation. All patients were followed up clinically for immediate,1,3,6 weeks, and 3 months postoperatively after the surgical operation to assess the occlusion, presence of numbness, bleeding, and possible temporomandibular joint (TMJ) changes. All patients underwent immediate and 3 months Ortho pantomogram, postoperative CT were superimposed to the planned preoperative CT scan to evaluate the accuracy of PSI in fixation and merging of Digital dental model to the postoperative CT scan.

Conditions

• Mandible Prognathism
• Mandibular Retrognathism

Interventions

Type	Name	Description
DEVICE	PSI	orthognathic surgery BSSO using PSI

Timeline

• Start date: 2023-01-10
• Primary completion: 2025-04-15
• Completion: 2025-05-20
• First posted: 2025-10-30
• Last updated: 2025-10-30

Locations

1 site across 1 country: Egypt

Regulatory

• FDA-regulated device study