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)
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Cairo University
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Postoperative occlusion
Study Overview
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:
- 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.
- All ages and both sexes were included in this study.
- Patients should be free from any systemic disease that may affect normal healing of bone, and predictable outcome.
- Patients with good general condition allowing major surgical procedure under general anesthesia.
- Patients with physical and psychological tolerance.
Exclusion criteria:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
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
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
- •All ages and both sexes were included in this study.
- •Patients should be free from any systemic disease that may affect normal healing of bone, and predictable outcome.
- •Patients with good general condition allowing major surgical procedure under general anesthesia.
- •Patients with physical and psychological tolerance.
Exclusion Criteria
- •Patients with physical and psychological intolerance. Because psychological stress will affect the immune system and general health.
- •Patients with systemic diseases like uncontrolled diabetes mellitus. Because uncontrolled diabetes mellitus has a negative impact on normal bone healing.
- •Patients with old and/or mal-union fractures. As they will affect accuracy of reduction of the fractured segments.
- •Patient with bad oral hygiene. As it has an influence on normal osseous healing
Arms & Interventions
Custom made PEEK plate fixation
Open Reduction Internal Fixation using Custom made PEEK plates.
Intervention: Custom made PEEK plate fixation (Procedure)
Titanium plate fixation
Open Reduction Internal Fixation using conventional titanium plating system.
Intervention: Titanium plate fixation (Procedure)
Outcomes
Primary Outcomes
Postoperative occlusion
Time Frame: 1 month postoperative
Restoration of normal patient occlusion will be assessed using Visual analog scale (VAS) (0-10)
Secondary Outcomes
- Accuracy of the planned reduction(1st week)
- Wound dehiscence(1 month postoperative)
- The need for 2nd surgery(1 month postoperative)
- Operative time(During operation)
Investigators
Rofaida Atef Atef
Assistant lecturer
Cairo University