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Completed

NCT Number: NCT07520227

Comparative Evaluation of 3D-printed (PEEK) Plates Versus Titanium 3D Plate for Fracture Fixation at the Mandibular Angle

Is patient specific customized computer assisted 3D PEEK plates more superior to 3D titanium plate in fixation of mandibular angle fractures?

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Key information

Conditions

Fracture Mandible Craniocerebral Trauma Facial Injuries Fractures, Bone Jaw Fractures Mandibular Fractures Maxillofacial Injuries Nervous System Diseases Skull Fractures Trauma, Nervous System Wounds and Injuries

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Osama Abdelaziz Abdelreheem

Cairo, Egypt

About this study

Open Reduction Internal fixation (ORIF) of mandibular angle fractures using titanium plating systems had several drawbacks including sepsis with subsequent wound dehiscence and the need for 2nd surgery which is attributed to bone loss as a result of the elevated modulus of elasticity of titanium hardware. Accordingly, attempts were made to overcome problems encountered with the titanium plating system. In this study, custom made PEEK 3D plates will be used in ORIF of mandibular angle fractures. The main beneficial property of PEEK material is its lower modulus of elasticity that is close to that of living bone with subsequent elimination of the problem of stress shielding phenomenon encountered with titanium plating system. PEEK material has other advantages including biocompatibility, mechanical strength, durability, resistance to high degree of temperature without dimensional alteration.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with mandibular angle fractures indicated for open reduction and internal fixation (ORIF).
  • Patients aged 18 years and above.
  • Both male and female patients.
  • Patients medically fit for surgery under general anesthesia.
  • Patients providing informed consent.

Exclusion criteria

  • Patients with pathological fractures.
  • Patients with comminuted fractures not suitable for fixation with plates.
  • Patients with systemic conditions affecting bone healing (e.g., uncontrolled diabetes, osteoporosis).
  • Patients with a history of previous mandibular surgery in the same region.
  • Patients who are unable or unwilling to comply with follow-up.

Treatment and study plan

Patient-specific PEEK plates manufactured using CAD/CAM technology and fixed using titanium screws.

Device

Patient-specific PEEK plates manufactured using CAD/CAM technology and fixed using titanium screws.

Conventional 3D titanium plates

Device

Conventional 3D titanium plates used for fixation of mandibular angle fractures with titanium screws.

Primary outcomes

  1. Postoperative occlusion stability(binary: yes/no)

    Time frame: 1 week, 1 month, and 6 months postoperatively

    Occlusal stability was recorded as stable or unstable. Occlusal stability was assessed clinically by evaluating the intercuspation between maxillary and mandibular teeth. Proper occlusion was defined as normal intercuspation without premature contacts or occlusal discrepancies. Any deviation, including open bite or malocclusion, was recorded during follow-up.

Secondary outcomes

  1. Condylar seating (binary: yes/no)

    Time frame: 1 week, 1 month, and 6 months postoperatively

    Condylar seating was assessed radiographically using standardized panoramic radiographs. The position of the mandibular condyle within the glenoid fossa was evaluated. Proper condylar seating was defined as a normal anatomical position without displacement. Any deviation from the normal position was recorded as improper.

  2. Postoperative infection (binary: yes/no)

    Time frame: 1 week, 1 month, and 6 months postoperatively

    Postoperative infection was recorded as present or absent.

  3. Wound dehiscence (binary: yes/no)

    Time frame: 1 week, 1 month, and 6 months postoperatively

    Wound dehiscence was recorded as present or absent.

  4. Need for second surgical intervention ( binary: yes/no)

    Time frame: 1 week, 1 month, and 6 months postoperatively

    Need for second surgery was recorded as yes or no.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Comparative Evaluation of 3D-printed Polyetheretherketone (PEEK) Plates Versus Titanium 3D Plate for Fracture Fixation at the Mandibular Angle

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 9, 2026
Registry last updated
Apr 9, 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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