NCT05240963

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2019

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2021

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

February 5, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 15, 2022

Completed
Last Updated

February 15, 2022

Status Verified

February 1, 2022

Enrollment Period

1.7 years

First QC Date

February 5, 2022

Last Update Submit

February 5, 2022

Conditions

Temporal Hollowing

Outcome Measures

Primary Outcomes (1)

  • patient's satisfaction

    patient's satisfaction using five points Likert scale

    3 weeks postoperative

Study Arms (1)

PEEK implant

EXPERIMENTAL

Temporal PEEK implant to prevent temporal hollowing after temporalis muscle transfer

Procedure: Temporal PEEK implant

Interventions

Temporal PEEK implantPROCEDURE

Temporal PEEK implant to reconstruct temporal fossa after temporalis muscle transfer

PEEK implant

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of dentistry, Cairo university

Cairo, 11728, Egypt

Location

Related Publications (1)

  • 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.

    PMID: 35524015DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 5, 2022

First Posted

February 15, 2022

Study Start

August 1, 2019

Primary Completion

April 30, 2021

Study Completion

April 30, 2021

Last Updated

February 15, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)