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Completed

NCT Number: NCT07222904

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

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

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Key information

Conditions

Mandible Prognathism Malocclusion Malocclusion, Angle Class III Mandibular Retrognathism Stomatognathic Diseases Tooth Diseases

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eman Ashour

Cairo, 12345, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

PSI

Device

orthognathic surgery BSSO using PSI

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Faculty of Dental Medicine for Girls

Other Gov

Registry information

Acronym: BSSO

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Oct 30, 2025
Registry last updated
Oct 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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