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

Faculty of Dental Medicine for Girls

Status: Completed

Conditions: Mandible Prognathism; Mandibular Retrognathism

Treatments: Device: PSI

Study type: Interventional

Funder types: Other

Identifiers

NCT07222904

OR SUR-108-2-1

Details and patient eligibility

About

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

Full 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.

Enrollment: 8 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

BSSO using PSI

Experimental group

Description:

8 Patients underwent bilateral sagittal split Osteotomy fixed with patient' specific implants

Treatment:

Device: PSI