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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07222904

Acronym

BSSO

Enrollment

Registered

2025-10-30

Start date

2023-01-10

Completion date

2025-05-20

Last updated

2025-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mandible Prognathism, Mandibular Retrognathism

Keywords

Mandibular orthognathic, BSSO, Virtual planning

Brief 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.

Interventions

DEVICEPSI

orthognathic surgery BSSO using PSI

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 40 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
Accuracy of PSI and bony segment movements	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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026