NCT07729345

Brief Summary

The design of the custom made Plates is customized to meet the individual needs of each patient and surgeon. By selecting plate design features, surgeons can customize the plate to create a patient specific solution. The Patient Specific Plates are manufactured to the planned patient anatomy, eliminating the time needed for intraoperative adaption and creating a stronger plate with a lower overall profile. But Custom made plates were made in many materials such as titanium, Vitalium, PEEK, etc In this study we will compare the PEEK one with the titanium one to know which one is better in all aspects and if the PEEK one can overcome the shortcoming of the titanium one or not.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2025

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

February 1, 2025

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2026

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

July 22, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 27, 2026

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Completed
Last Updated

July 27, 2026

Status Verified

July 1, 2026

Enrollment Period

1.5 years

First QC Date

July 22, 2026

Last Update Submit

July 24, 2026

Conditions

Mandibular Body Fractures

Keywords

PEEKmandibular body fracturestitanium plates

Outcome Measures

Primary Outcomes (1)

  • radiographic assessment of accuracy in mandibular body fractures management

    using Mimics software

    3 months

Study Arms (1)

PEEK

EXPERIMENTAL

computer-assisted Polyether ether ketone (PEEK) custom made plates

Procedure: computer-assisted Polyether ether ketone (PEEK) custom made plates

Interventions

computer-assisted Polyether ether ketone (PEEK) custom made platesPROCEDURE

computer-assisted Polyether ether ketone (PEEK) custom made plates in mandibular body fractures management

PEEK

Eligibility Criteria

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

You may qualify if:

  • Patients with at least a unilateral body fracture indicated for Open reduction internal fixation.
  • Dentate adult patients.
  • All ages and both sexes were included in this study.

You may not qualify if:

  • Patients with systemic disease (may affect normal healing).
  • Patients with old and/or mal united fractures (affect accuracy of re-reduced the fractured segments).
  • Patients whom cannot tolerate follow up intervals (affect accuracy of study results).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Giza, Cairo Governorate, 12515, Egypt

Location

MeSH Terms

Interventions

polyetheretherketone

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 of oral and maxillofacial surgery

Study Record Dates

First Submitted

July 22, 2026

First Posted

July 27, 2026

Study Start

February 1, 2025

Primary Completion

July 20, 2026

Study Completion

August 1, 2026

Last Updated

July 27, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)