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

NCT ID: NCT07222904

Last Updated: 2025-10-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-10
• Study Completion Date: 2025-05-20

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BSSO using PSI

8 Patients underwent bilateral sagittal split Osteotomy fixed with patient' specific implants

Group Type: EXPERIMENTAL

PSI

Intervention Type: DEVICE

orthognathic surgery BSSO using PSI

Interventions

PSI

orthognathic surgery BSSO using PSI

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Age range of patients 18-40 years old, with no gender prediction, able to read and sign the informed consent.

2. Patients with skeletal class II or class III who are in need of mandibular orthognathic surgery.

Exclusion Criteria

1. Patients who had previous orthognathic surgery.

2. Patients with previous severe facial trauma history or fracture mandible.

3. Patients with congenital facial asymmetry.

4. Patients with systemic diseases and immunocompromised patient.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Faculty of Dental Medicine for Girls

OTHER_GOV

Sponsor Role: lead

Responsible Party

Eman Ashour

Assistant Lecturer at Oral and Maxillofacial Surgery department at AlAzhar University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hatem AlAhmady, Professor

Role: STUDY_CHAIR

Professor of maxillofacial surgery department azhar university

Locations

Eman Ashour

Cairo, , Egypt

Countries

Egypt

Other Identifiers

OR SUR-108-2-1

Identifier Type: -

Identifier Source: org_study_id