Patient Specific PEEK Implants for Immediate Restoration of Temporal Fossa After Maxillary Reconstruction With Temporalis Muscle Flap

Not Applicable

Completed

• Conditions: Temporal Hollowing
• Interventions: Procedure: Temporal PEEK implant

• Registration Number: NCT05240963
• Lead Sponsor: Cairo University

Brief Summary

Study conducted on patients with major maxillary defects indicating the need of reconstruction with full temporalis muscle flap; or any lesion indicating major maxillary resection and immediate reconstruction with total temporalis muscle flap.

For each patient, a patient specific PEEK implant was fabricated, the temporalis muscle was exposed, elevated, and transferred to the maxilla, finally PEEK implants were fixed in place to prevent temporal hollowing.

Detailed Description

Study conducted on patients with major maxillary defects indicating the need of reconstruction with full temporalis muscle flap; or any lesion indicating major maxillary resection and immediate reconstruction with total temporalis muscle flap.

For each patient, a patient specific PEEK implant was fabricated, the temporalis muscle was exposed, elevated, and transferred to the maxilla, finally PEEK implants were fixed in place to prevent temporal hollowing.

Study Timeline

• Study Start: 2019-08-01
• Primary Completion: 2021-04-30
• Study Completion: 2021-04-30
• Status Verified: 2022-02
• Study First Submitted: 2022-02-05
• Study First Submitted QC: 2022-02-05
• Last Update Submitted: 2022-02-05
• Study First Posted: 2022-02-15
• Last Update Posted: 2022-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

• Patients with major maxillary defects indicating the need of reconstruction with full temporalis muscle flap; or any lesion indicating major maxillary resection and immediate reconstruction with total temporalis muscle flap.

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PEEK implant	Temporal PEEK implant	Temporal PEEK implant to prevent temporal hollowing after temporalis muscle transfer

Primary Outcome Measures

Name	Time	Method
patient's satisfaction	3 weeks postoperative	patient's satisfaction using five points Likert scale

Trial Locations

Locations (1)

Faculty of dentistry, Cairo university; 🇪🇬 Cairo, Egypt