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NCT Number: NCT07729345

Assessment Polyether Ether Ketone (PEEK) Custom Made Plates Versuscustom Made Titanium Plates in Treatment of Mandibular Body Fractures

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Mandibular Body Fractures

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cairo University

Giza, Cairo Governorate, 12515, Egypt

About this study

In patients with mandibular body fractures, will PEEK custom made plates be more efficient in reduction of body fractures accurately than titanium custom made plates (in terms of radiographic and clinical parameters)?

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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).

Treatment and study plan

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

Procedure

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

Primary outcomes

  1. radiographic assessment of accuracy in mandibular body fractures management

    Time frame: 3 months

    using Mimics software

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Radiographic Assessment of Accuracy of Computer-assisted Polyether Ether Ketone (PEEK) Custom Made Plates Versus Computer-assisted Custom Made Titanium Plates in Treatment of Mandibular Body Fractures (A Randomized Clinical Trial)

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 27, 2026
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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