Patient-specific PEEK Implants for Post-maxillectomy Orbital Floor Reconstruction

NCT07789392 | Completed Phase 4

• 1 other identifier: 0772-09/2023
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to evaluate the utilization of Patient-specific PEEK implantsd in reconstruction of orbital floor after maxilla ablation surgery

Conditions

Orbital Floor Reconstruction; PEEK IMPLANTS; MAXILLECTOMY

Outcome Measures

Primary Outcomes (2)

• Enophthalmos analysis

  On the axial cuts, at the level of a horizontal dissecting line (Baseline) was drawn joining the anterior tips of the lateral orbital margin bilaterally. The perpendicular distance from the top of the corneal bulge to this line was measured for both the affected and the contralateral globes. The difference in the measurement value between the normal and the affected orbit was used to conclude the presence or absence of enophthalmos, or proptosis of the orbit, using the equation (Globe Δ = Contralateral value-Ipsilateral Value). A reported difference between both globes of more than 2 mm is designated as enophthalmos

  Immediately after the surgery

• Orbital Volume Evaluation

  An appraisal of the orbital volume will be performed as an objective evaluation modality for the assessment of the accuracy of orbital floor reconstruction after Brown class III maxillectomies in both groups. A virtual orbital model of the reconstructed eye will be created using manual segmentation module in the 3D segmentation and image analysis software\* for the following: * Ipsilateral preoperative virtually reconstructed orbit. * Ipsilateral immediate postoperative CT-scan of the reconstructed orbit. * Contralateral preoperative and immediate postoperative orbit. The volume of the created orbital model will be automatically calculated and the mean value for each model will be calculated. In each group, efficiency of orbital floor reconstruction will be evaluated by comparing the postoperative value with the preoperative one and with the normal contralateral side.

  Immediately after the surgery

Secondary Outcomes (2)

• Ocular postoperative complications

  1 week postopreatively

• Ocular motility and Diplopia

  1 week postopreatively

Study Arms (1)

patients will be treated by Brown class III maxillectomy and immediate orbital floor reconstruction

EXPERIMENTAL

Device: Patient-specific PEEK implants

Interventions

Patient-specific PEEK implants DEVICE

patients will be treated by Brown class III maxillectomy and immediate orbital floor reconstruction by Patient-specific PEEK implants

patients will be treated by Brown class III maxillectomy and immediate orbital floor reconstruction

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \. Unilateral invasive benign or malignant tumors of the maxilla that requires orbital floor resection.
• \. Brown class III maxillectomy defects patients 2. Patients with immediate orbital floor reconstruction will be enrolled in this study.

You may not qualify if:

• Medically compromised patients contradicting operation.
• Delayed orbital floor reconstruction cases will be excluded.
• Bilateral cases will be excluded.

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Faculty of dentistry, Alexandria university

Alexandria, 21523, Egypt

Location

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2026
• First Posted: August 27, 2026
• Study Start: October 1, 2023
• Primary Completion: May 1, 2025
• Study Completion: February 1, 2026
• Last Updated: August 27, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)