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

NCT07222904 | Completed FDA Device

• 1 other identifier: OR SUR-108-2-1
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Mandible Prognathism; Mandibular Retrognathism

Keywords

Mandibular orthognathic; BSSO; Virtual planning

Outcome Measures

Primary Outcomes (1)

• Accuracy of PSI and bony segment movements

  Measurements using CT software after superimposition using (Mimics and 3-Matic) through fixation landmark points on both virtually planned repositioned mandible and the actual postoperative mandible, all in identical locations. Then linear measurements were performed between defined anatomical landmarks on both models using Measure distance tool, as well as between each landmark and the constructed reference planes

  Baseline (preoperative), immediate postoperative, and 3-month postoperative follow-up.

Study Arms (1)

BSSO using PSI

EXPERIMENTAL

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

Device: PSI

Interventions

PSI DEVICE

orthognathic surgery BSSO using PSI

BSSO using PSI

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age range of patients 18-40 years old, with no gender prediction, able to read and sign the informed consent.
• Patients with skeletal class II or class III who are in need of mandibular orthognathic surgery.

You may not qualify if:

• Patients who had previous orthognathic surgery.
• Patients with previous severe facial trauma history or fracture mandible.
• Patients with congenital facial asymmetry.
• Patients with systemic diseases and immunocompromised patient.

Sponsors & Collaborators

• Faculty of Dental Medicine for Girls: lead

Study Sites (1)

Eman Ashour

Cairo, 12345, Egypt

Location

MeSH Terms

Conditions

Malocclusion, Angle Class III

Condition Hierarchy (Ancestors)

Malocclusion; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Hatem AlAhmady, Professor

  Professor of maxillofacial surgery department azhar university

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer at Oral and Maxillofacial Surgery department at AlAzhar University

Study Record Dates

• First Submitted: October 27, 2025
• First Posted: October 30, 2025
• Study Start: January 10, 2023
• Primary Completion: April 15, 2025
• Study Completion: May 20, 2025
• Last Updated: October 30, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)