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

NCT ID: NCT05240963

Last Updated: 2022-02-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-01

Study Completion Date

2021-04-30

Brief Summary

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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

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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.

Conditions

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Temporal Hollowing

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PEEK implant

Temporal PEEK implant to prevent temporal hollowing after temporalis muscle transfer

Group Type EXPERIMENTAL

Temporal PEEK implant

Intervention Type PROCEDURE

Temporal PEEK implant to reconstruct temporal fossa after temporalis muscle transfer

Interventions

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Temporal PEEK implant

Temporal PEEK implant to reconstruct temporal fossa after temporalis muscle transfer

Intervention Type PROCEDURE

Eligibility Criteria

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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

\-
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Sherif Ali

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of dentistry, Cairo university

Cairo, , Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type DERIVED
PMID: 35524015 (View on PubMed)

Other Identifiers

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OMFS-19715

Identifier Type: -

Identifier Source: org_study_id

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