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

Faculty of Dental Medicine for Girls8 enrolled

Overview

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

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Mandible Prognathism Mandibular Retrognathism

Interventions

PSIDEVICE

orthognathic surgery BSSO using PSI

Eligibility

Sex: ALLMin age: 18 YearsMax age: 40 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

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

Data from ClinicalTrials.gov

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