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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-02

Study Completion Date

2019-03-02

Brief Summary

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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.

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Detailed Description

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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

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Fracture Mandible Mandibular Fractures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

* A Randomized clinical trial.
* A trial will be carried out in hospital of Oral and Maxillofacial surgery department- Faculty of Oral and Dental Medicine Cairo University
* Equal randomization: participants with equal probabilities for intervention.
* Positive controlled: Both groups receiving treatment.
* Parallel group study: Each group of patients receives a single treatment simultaneously.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Because the two interventions used in this trial are clearly different and easily recognized by the participants and investigators, neither the investigator nor participants can be blinded

Study Groups

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Custom made PEEK plate fixation

Open Reduction Internal Fixation using Custom made PEEK plates.

Group Type EXPERIMENTAL

Custom made PEEK plate fixation

Intervention Type PROCEDURE

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.

Titanium plate fixation

Open Reduction Internal Fixation using conventional titanium plating system.

Group Type ACTIVE_COMPARATOR

Titanium plate fixation

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Other Intervention Names

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Conventional titanium plates Computer-assisted PEEK plate fixation

Eligibility Criteria

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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.

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

Eligible Sex

ALL

Accepts Healthy Volunteers

No