Mandibular Angle Fracture, Polyetheretherketone, Three Dimensional
Conditions
Keywords
mandibular angle fracture, PEEK, three-dimensional plate fixation
Brief summary
This investigation aimed to determine the clinical and radiographic efficacy of patient-specific, custom-made 3D PEEK plates in comparison with 3D titanium plates for the management of mandibular angle fractures.
Detailed description
Eighteen patients with recent mandibular angle fractures indicated for open reduction and internal fixation were randomly allocated into two groups. The study group (n = 9) underwent fixation with custom-made 3D PEEK plates, while the control group (n = 9) received prebent 3D titanium plates adapted on virtually reduced models. Follow-up extended to 12 weeks. Clinical parameters included operative time, postoperative occlusion, interfragmentary stability, wound healing, and bite force recovery. Radiographic evaluation was conducted using computed tomography scans acquired immediately postoperatively and at 12 weeks, assessing fracture healing and mean bone density.
Interventions
DEVICECustome made 3D PEEK plate
Custome made 3D PEEK plate
DEVICE3D Titanium plate
Pre-bent 3D Titanium plate
Sponsors
Alexandria University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Masking description
Patients were allocated in a 1:1 ratio using an on-site computer software system with concealed allocation through sequentially numbered, opaque, sealed envelopes (SNOSE). Group A was treated with custom made 3D PEEK plates and Group B with 3D titanium plates.
Intervention model description
Randomized controlled clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patients with recent mandibular angle fracture adults without gender predilection who agreed to follow-up, fractures requiring open reduction and internal fixation, medically fit for general anesthesia
Exclusion criteria
* medically compromised patients, fractures with infection, pathological or old fractures, completely edentulous patients, comminuted fractures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Radiographic evaluation for the assessment of mean bone density at the fracture line [Time Frame: 12 weeks] | 12 weeks | Mean bone density at the fracture line was assessed using Computed Tomography (CT) scan in Hounsfield Units (HU) |
| Bite force recovery. | 12 weeks | bite force recovery measured by a Piezoresistive force transduce sensor: FlexiForce A201 sensor (FlexiForce sensor, by Tekscan Boston, MA, USA. www.tekscan.com) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical evaluation for interfragmentary stability. | 12 weeks | Intra-fragmentary mobility was evaluated by bimanual palpation at the fracture site |
| clinical evaluation of wound healing | 14 days | Wound healing is graded according to Southampton wound-grading system |
| Clinical evaluation of postoperative occlusion | 12 week | By checking the maximal intercuspal position (centric occlusion) to ensure proper occlusal relationship including molar relation, canine relation and midline centralization |
Countries
Egypt
Outcome results
None listed