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CompletedNCT05240963Updated Feb 15, 2022

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

An interventional study of Temporal PEEK implant in Temporal Hollowing, sponsored by Cairo University. Completed at 1 site in Egypt. Per ClinicalTrials.gov, last updated 2022-02-15.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 6 months after the study started (first participant enrolled Aug 2019, registered Feb 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
8
Allocation
Not applicable
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Temporal Hollowing
03

In context

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
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

Exclusion Criteria:

-

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
8 participants (actual)

Study arms

  • Experimental
    PEEK implant

    Temporal PEEK implant to prevent temporal hollowing after temporalis muscle transfer

    Procedure: Temporal PEEK implant

Interventions

  • ProcedureTemporal PEEK implant

    Temporal PEEK implant to reconstruct temporal fossa after temporalis muscle transfer

06

What researchers measure

Primary outcomes

  1. patient's satisfaction

    patient's satisfaction using five points Likert scale

    Time frame: 3 weeks postoperative

07

Study locations

1 site
  • Faculty of dentistry, Cairo university
    Cairo, 11728, Egypt
08

References and documents

Publications

  • Ali S, Abdel Aziz O, Ahmed M. Patient-specific PEEK implants for immediate restoration of temporal fossa after maxillary reconstruction with temporalis muscle flap. Maxillofac Plast Reconstr Surg. 2022 May 7;44(1):20. doi: 10.1186/s40902-022-00348-4. PubMed 35524015 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 15, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05240963
Lead sponsor
Cairo University
Responsible party
Sherif Ali (Associate Professor, Cairo University) — Principal investigator
First posted
Feb 15, 2022
Start date
Aug 1, 2019
Primary completion
Apr 30, 2021
Completion
Apr 30, 2021
Last update
Feb 15, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.

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