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

• ClinicalTrials.gov Identifier: NCT03466190
• Recruitment Status: Unknown
• First Posted: March 15, 2018
• Last Update Posted: March 15, 2018
• Sponsor: Cairo University
• Information provided by (Responsible Party): Rofaida Atef Atef, Cairo University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Fracture Mandible; Mandibular Fractures	Procedure: Titanium plate fixation; Procedure: Custom made PEEK plate fixation	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment

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.

• Masking: None (Open Label)
• Masking Description: 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
• Primary Purpose: Treatment
• 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)
• Actual Study Start Date: August 2, 2017
• Estimated Primary Completion Date: March 2, 2019
• Estimated Study Completion Date: March 2, 2019

Arms and Interventions

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 Name: 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 Name: Conventional titanium plates

Outcome Measures

Primary Outcome Measures :

1. Postoperative occlusion [ Time Frame: 1 month postoperative ]

   Restoration of normal patient occlusion will be assessed using Visual analog scale (VAS)

   (0-10)

Secondary Outcome Measures :

1. Accuracy of the planned reduction [ Time Frame: 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)

2. Wound dehiscence [ Time Frame: 1 month postoperative ]
   Wound infection will be assessed via clinical assessment, measuring unit (Binary yes/no)
3. The need for 2nd surgery [ Time Frame: 1 month postoperative ]
   Redo surgery will be assessed via clinical assessment, measuring unit (Binary yes/no)
4. Operative time [ Time Frame: During operation ]
   Surgical time will be assessed via clinical assessment, measuring unit (hours)

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Contacts

Contact: Rofaida A Ahmad, MSc; +201099669299; ro_fy_at@yahoo.com

Contact: Rofaida A Ahmad, MSc; +201099669299; rofaidaatef14@gmail.com

Locations

Egypt

Faculty of Oral and Dental Medicine -Cairo University; Recruiting

Cairo, Giza, Egypt, 12613

Contact: Rofaida A Ahmad, MSc 01099669299 ro_fy_at@yahoo.com

Contact: Khaled Amr, PhD 01006029031 khaledamr82@hotmail.com

Principal Investigator: Rofaida A Ahmad, MSc

Sponsors and Collaborators

Cairo University

Investigators

• Study Director: Khaled Amr, PhD; Faculty of Oral and Dental Medicine -Cairo University

More Information

Additional Information:

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. 

Pattern and treatment of mandible body fracture 

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 

• Responsible Party: Rofaida Atef Atef, Assistant lecturer, Cairo University
• ClinicalTrials.gov Identifier: NCT03466190
• Other Study ID Numbers: CEBD-CU-2018-02-27
• First Posted: March 15, 2018
• Last Update Posted: March 15, 2018
• Last Verified: March 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Rofaida Atef Atef, Cairo University:

Mandibular body fractures, PEEK plates, titanium plates.

Additional relevant MeSH terms:

Mandibular Fractures; Fractures, Bone; Wounds and Injuries; Jaw Fractures; Maxillofacial Injuries; Facial Injuries; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Skull Fractures