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Evaluation of the Accuracy of Patient Specific Implant in Fixation of Mandibular Sagittal Split Osteotomy | Clinical Trials | Clareo Health

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

NCT07222904•Faculty of Dental Medicine for Girls

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 40 years

Sex

ALL

Healthy Volunteers

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.

Locations (1)

Eman Ashour

Cairo, Egypt

Key Dates

Start Date

January 10, 2023

Primary Completion Date

April 15, 2025

Completion Date

May 20, 2025

Last Updated

October 30, 2025

Enrollment

ACTUAL participants

Conditions

Mandible PrognathismMandibular Retrognathism

Interventions

PSI

DEVICE

Condylar Position Changes and TMJ Functions After BSSO Mandibular Setback, Low Medial Cut.

NCT05713084

Maxillofacial AbnormalitiesMandible Prognathism+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 30, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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