Clinical trial NCT03466190: Clinical Assessment of Computer-assisted PEEK Versus Conventional Titanium Plates on Mandibular Body Fractures
Official title: 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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fracture Mandible
Mandibular Fractures
Keywords: Mandibular body fractures, PEEK plates, titanium plates.
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-03-15
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: * 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 purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Postoperative occlusion
timeFrame: 1 month postoperative
Secondary outcomes:
measure: Accuracy of the planned reduction
timeFrame: 1st week
measure: Wound dehiscence
timeFrame: 1 month postoperative
measure: The need for 2nd surgery
timeFrame: 1 month postoperative
measure: Operative time
timeFrame: During operation
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Oral and Dental Medicine -Cairo University
state: Giza
Study officials:
affiliation: Faculty of Oral and Dental Medicine -Cairo University
name: Khaled Amr, PhD
role: STUDY_DIRECTOR
References: