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)

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.

Study Overview

• Status: Unknown
• Conditions: Mandibular Fractures; Fracture Mandible
• Intervention / Treatment: Procedure: Custom made PEEK plate fixation; Procedure: Titanium plate fixation

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 Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rofaida A Ahmad, MSc; Phone Number: +201099669299; Email: ro_fy_at@yahoo.com
• Study Contact Backup: Name: Rofaida A Ahmad, MSc; Phone Number: +201099669299; Email: rofaidaatef14@gmail.com

Study Locations

• Egypt
  • Giza
    • Cairo, Giza, Egypt, 12613
      • Recruiting
      • faculty of oral and dental medicine -cairo university
      • Contact: Rofaida A Ahmad, MSc; Phone Number: 01099669299; Email: ro_fy_at@yahoo.com
      • Contact: Khaled Amr, PhD; Phone Number: 01006029031; Email: khaledamr82@hotmail.com
      • Principal Investigator: Rofaida A Ahmad, MSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Custom made PEEK plate fixation; Open Reduction Internal Fixation using Custom made PEEK plates.	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.; Other Names: Computer-assisted PEEK plate fixation
ACTIVE_COMPARATOR: Titanium plate fixation; Open Reduction Internal Fixation using conventional titanium plating system.	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.; Other Names: Conventional titanium plates

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative occlusion	Restoration of normal patient occlusion will be assessed using Visual analog scale (VAS) (0-10)	1 month postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy of the planned reduction	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)	1st week
Wound dehiscence	Wound infection will be assessed via clinical assessment, measuring unit (Binary yes/no)	1 month postoperative
The need for 2nd surgery	Redo surgery will be assessed via clinical assessment, measuring unit (Binary yes/no)	1 month postoperative
Operative time	Surgical time will be assessed via clinical assessment, measuring unit (hours)	During operation

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Director: Khaled Amr, PhD, faculty of oral and dental medicine -cairo university

Publications and helpful links

Helpful Links

• Open reduction and rigid internal fixation of mandibular condylar fractures by an intraoral approach: a long-term follow-up study of 15 patients
• Accuracy of the Computer-Aided Surgical Simulation (CASS) System in the Treatment of Patients With Complex Craniomaxillofacial Deformity: A Pilot Study.
• A Comparative Evaluation of Fixation Techniques in Anterior Mandibular Fractures Using 2.0 mm Monocortical Titanium Miniplates Versus 2.4 mm Cortical Titanium Lag Screws
• Titanium osteosynthesis hardware in maxillofacial trauma surgery: to remove or remain? A retrospective study.
• Camerani, et al. Reconstruction of frontal bone using specific implant polyether-ether-ketone
• The effect of diabetes mellitus on osseous healing.
• Unfavourable outcomes in maxillofacial injuries: How to avoid and manage
• Stress-induced immune dysregulation: Implications for wound healing, infectious disease and cancer

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 2, 2017
• Primary Completion (ANTICIPATED): March 2, 2019
• Study Completion (ANTICIPATED): March 2, 2019

Study Registration Dates

• First Submitted: March 2, 2018
• First Submitted That Met QC Criteria: March 8, 2018
• First Posted (ACTUAL): March 15, 2018

Study Record Updates

• Last Update Posted (ACTUAL): March 15, 2018
• Last Update Submitted That Met QC Criteria: March 8, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: Mandibular body fractures, PEEK plates, titanium plates.
• Additional Relevant MeSH Terms: Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Jaw Fractures; Maxillofacial Injuries; Facial Injuries; Skull Fractures; Fractures, Bone; Mandibular Fractures
• Other Study ID Numbers: CEBD-CU-2018-02-27

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No