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

Not Applicable

• Conditions: Fracture Mandible; Mandibular Fractures
• Interventions: Procedure: Titanium plate fixation; Procedure: Custom made PEEK plate fixation

• Registration Number: NCT03466190
• Lead Sponsor: Cairo University

Brief 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.

Study Timeline

• Study Start: 2017-08-02
• Status Verified: 2018-03
• Study First Submitted: 2018-03-02
• Study First Submitted QC: 2018-03-08
• Last Update Submitted: 2018-03-08
• Study First Posted: 2018-03-15
• Last Update Posted: 2018-03-15
• Primary Completion: 2019-03-02
• Study Completion: 2019-03-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

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.

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Exclusion Criteria

1. Patients with physical and psychological intolerance. Because psychological stress will affect the immune system and general health.
2. Patients with systemic diseases like uncontrolled diabetes mellitus. Because uncontrolled diabetes mellitus has a negative impact on normal bone healing.
3. Patients with old and/or mal-union fractures. As they will affect accuracy of reduction of the fractured segments.
4. Patient with bad oral hygiene. As it has an influence on normal osseous healing

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Titanium plate fixation	Titanium plate fixation	Open Reduction Internal Fixation using conventional titanium plating system.
Custom made PEEK plate fixation	Custom made PEEK plate fixation	Open Reduction Internal Fixation using Custom made PEEK plates.

Primary Outcome Measures

Name	Time	Method
Postoperative occlusion	1 month postoperative	Restoration of normal patient occlusion will be assessed using Visual analog scale (VAS); (0-10)

Secondary Outcome Measures

Name	Time	Method
Accuracy of the planned reduction	1st week	The accuracy of computer assisted PEEK custom made plates in open reduction and; internal fixation of mandibular body fractures will be assessed using Mimics software, measuring unit (mm)
Wound dehiscence	1 month postoperative	Wound infection will be assessed via clinical assessment, measuring unit (Binary yes/no)
The need for 2nd surgery	1 month postoperative	Redo surgery will be assessed via clinical assessment, measuring unit (Binary yes/no)
Operative time	During operation	Surgical time will be assessed via clinical assessment, measuring unit (hours)

Trial Locations

Locations (1)

Faculty of Oral and Dental Medicine -Cairo University; 🇪🇬 Cairo, Giza, Egypt