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

• Sponsor: Cairo University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05240963
• Collaborator: (none)
• Enrollment: 8
• Location: 1
• Arm: 1
• Actual Duration (Months): 21
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Temporal Hollowing	Procedure: Temporal PEEK implant	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 8 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Patient Specific PEEK Implants for Immediate Restoration of Temporal Fossa After Maxillary Reconstruction With Temporalis Muscle Flap
• Actual Study Start Date: Aug 1, 2019
• Actual Primary Completion Date: Apr 30, 2021
• Actual Study Completion Date: Apr 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PEEK implant Temporal PEEK implant to prevent temporal hollowing after temporalis muscle transfer	Procedure: Temporal PEEK implant; Temporal PEEK implant to reconstruct temporal fossa after temporalis muscle transfer

Outcome Measures

Primary Outcome Measures

1. patient's satisfaction [3 weeks postoperative]

   patient's satisfaction using five points Likert scale

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of dentistry, Cairo university	Cairo		Egypt	11728

Sponsors and Collaborators

• Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sherif Ali, Associate Professor, Cairo University
• ClinicalTrials.gov Identifier: NCT05240963
• Other Study ID Numbers: OMFS-19715
• First Posted: Feb 15, 2022
• Last Update Posted: Feb 15, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Feb 15, 2022