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

October 29, 2025 updated by: Eman Ashour, Faculty of Dental Medicine for Girls
Study was Conducted on Patients were need BSSO Using PSI for reposition and fixation

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 12345
        • Eman Ashour

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BSSO using PSI
8 Patients underwent bilateral sagittal split Osteotomy fixed with patient' specific implants
Device: PSI
orthognathic surgery BSSO using PSI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy of PSI and bony segment movements
Time Frame: Baseline (preoperative), immediate postoperative, and 3-month postoperative follow-up.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Faculty of Dental Medicine for Girls

Investigators

  • Study Chair: Hatem AlAhmady, Professor, Professor of maxillofacial surgery department azhar university

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2023

Primary Completion (Actual)

April 15, 2025

Study Completion (Actual)

May 20, 2025

Study Registration Dates

First Submitted

October 27, 2025

First Submitted That Met QC Criteria

October 29, 2025

First Posted (Estimated)

October 30, 2025

Study Record Updates

Last Update Posted (Estimated)

October 30, 2025

Last Update Submitted That Met QC Criteria

October 29, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OR SUR-108-2-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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