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

Mandibular Fractures Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03466190
• Other study ID #: CEBD-CU-2018-02-27
• Status: Recruiting
• Phase: N/A
• First received: March 2, 2018
• Last updated: March 8, 2018
• Start date: August 2, 2017
• Est. completion date: March 2, 2019

Study information

• Verified date: March 2018
• Source: Cairo University
• Contact: Rofaida A Ahmad, MSc
• Phone: +201099669299
• Email: ro_fy_at[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: March 2, 2019
• Est. primary completion date: March 2, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Fracture Mandible
• Fractures, Bone
• Mandibular Fractures

Intervention

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.
• 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.

Locations

Country	Name	City	State
Egypt	Faculty of Oral and Dental Medicine -Cairo University	Cairo	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative occlusion	Restoration of normal patient occlusion will be assessed using Visual analog scale (VAS); (0-10)	1 month postoperative
Secondary	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
Secondary	Wound dehiscence	Wound infection will be assessed via clinical assessment, measuring unit (Binary yes/no)	1 month postoperative
Secondary	The need for 2nd surgery	Redo surgery will be assessed via clinical assessment, measuring unit (Binary yes/no)	1 month postoperative
Secondary	Operative time	Surgical time will be assessed via clinical assessment, measuring unit (hours)	During operation

External Links

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