Clinical and Radiographical Assessment of Patients With Sub-condylar Fracture Using Polyetheretherketone (PEEK) Trapezoidal Plates Versus Titanium Trapezoidal Plates

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCairo University

About this trial

Some of titanium's drawbacks that is commonly used in maxillofacial surgery included scatter artefacts on regular imaging, implant exposure and inflammation, high thermal conductivity, and high elastic modulus. Very few clinical studies have been published on using a PEEK plate in the mandibular fractures and to the best of the author's knowledge, this is the first study that will be done comparing trapezoidal condylar 3D printed PEEK plates and titanium trapezoidal condylar plate in subcondylar fractures in terms of clinical and radiographical outcomes.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients aged 18 years or older, irrespective of gender

Recent mandibular subcondylar fractures indicated for open reduction and internal fixation

Disqualifiers

Medically compromised patients contradicting operation (ASA III, IV & V).

Patients receiving radiotherapy or chemotherapy.

Infection at the fracture line.

Pathological fractures and old fractures

Trial design

Design model

Parallel

Treatments tested in this trial

  • titanium trapezoidal plates

    Other intervention

    ORIF subcondylar fracture using trapezoidal titanium plates

  • PEEK trapezoidal plates

    Other intervention

    ORIF subcondylar fracture using trapezoidal PEEK plates

Treatment groups

24 Participants
are divided into 2 treatment groups
Group A: control groupExperimental treatment 1 intervention
Group B: comparator groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Maximum mouth opening

Maximum mouth opening is the distance between the incisal edges of the upper and lower central incisors at the midline when the mouth is opened as wide as possible without pain. It will be measured in millimeters (mm) using a caliper

Time frame
outcome will be measured postoperatively in 4 different time points. 1st time point is at 1 week after surgery. 2nd time is point at 1 month after surgery. 3rd time point is at 3 months after surgery. 4th time point is at 6 months after surgery

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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