NCT03466190

Clinical Assessment of Computer-assisted PEEK Versus Conventional Titanium Plates on Mandibular Body Fractures

Clinical Assessment of Postoperative Occlusion in Patient With Mandibular Body Fractures Reduced and Fixed With Computer-assisted Polyether Ether Ketone (PEEK) Custom Made Plates Versus Conventional Titanium Plates (RCT)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Cairo University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

Two groups of patients with mandibular body fractures indicated for Open reduction internal fixation alone or in combination with fractures elsewhere in the mandible or midface. First group will be subjected to traditional titanium internal rigid fixation. Second group will be subjected to custom made PEEK plates.

Detailed description

Two groups of patients with mandibular body fractures indicated for Open reduction internal fixation alone or in combination with fractures elsewhere in the mandible or midface. First group will be subjected to traditional titanium internal rigid fixation. Second group will be subjected to custom made PEEK plates. Inclusion criteria: All subjects were required: 1. Patients with at least a unilateral body fracture indicated for Open reduction internal fixation alone or in combination with fracture elsewhere in the mandible or midface. 2. All ages and both sexes were included in this study. 3. Patients should be free from any systemic disease that may affect normal healing of bone, and predictable outcome. 4. Patients with good general condition allowing major surgical procedure under general anesthesia. 5. Patients with physical and psychological tolerance. Exclusion criteria: 1. Patients with high risk systemic diseases like uncontrolled diabetes . As uncontrolled diabetes has a negative impact on normal bone healing. 2. Patients with old fractures. As they will affect accuracy of reduction of the fractured segments. 3. Patients with physical and psychological intolerance. As psychological stress will affect the immune system and patient's fitness including healing capacity. Interventions: Eligible patients will be randomized in equal proportions between the study group (PEEK custom made plates) and the control group (titanium plates). A- Computer-assisted PEEK custom made plates: * All cases will undergo surgery under general anesthesia. * Exposure of the fractured segments will be done using a standardized surgical approach. * The fractured segments will be reduced in normal anatomic position guided by customized plate. * Fracture fragments will be fixed using PEEK custom made plate utilizing 2.0 mm screws. B- Conventional titanium plates: * All cases will undergo surgery under general anesthesia. * Exposure of the fractured segments will be done using a standardized surgical approach. * Inter-maxillary fixation will be done. * The fractured segments will be reduced in normal anatomic position guided by occlusion. * The fracture fragments will be fixed using 2.3 titanium plate on the inferior border and 2.0 titanium plate on the superior border utilizing bone screws. Follow up: Clinical evaluation will be performed at the first week postoperative. Computed tomography will be performed at the first week postoperative then patients will be recalled for clinical evaluation every week for one month. Final follow up visit will be at 3 months postoperative.

Conditions

• Fracture Mandible
• Mandibular Fractures

Interventions

Type	Name	Description
PROCEDURE	Titanium plate fixation	Under General Anesthesia, exposure of the fractured mandibular body segments will be done using a standardized surgical approach. Open Reduction Internal Fixation using conventional titanium plates will be performed.
PROCEDURE	Custom made PEEK plate fixation	Under General Anesthesia, exposure of the fractured mandibular body segments will be done using a standardized surgical approach. Open Reduction Internal Fixation using custom made PEEK plates will be performed.

Timeline

• Start date: 2017-08-02
• Primary completion: 2019-03-02
• Completion: 2019-03-02
• First posted: 2018-03-15
• Last updated: 2018-03-15

Locations

1 site across 1 country: Egypt