Anterior Mandibular Fracture
Conditions
Keywords
anterior mandibular fracture, symphyseal fracture, para-symphyseal fracture, InterFlex plate, functionally stabilized fixation, miniplate
Brief summary
the study aims to compare InterFlex plate with conventional miniplates in management of symphyseal mandibular fracture clinically regarding pain, wound healing and postoperative occlusion, and radiographically regrading bone density.
Detailed description
A total of 18 patients with recent symphyseal mandibular fractures were allocated into two groups. Group A, comprising 9 patients, underwent treatment with the InterFlex plate, while Group B, also consisting of 9 patients, was treated with conventional two miniplates. Clinical evaluations were carried at multiple intervals up to 12 weeks postoperatively, with radiographic assessments performed immediately after surgery and at 12 weeks to measure mean bone density at the fracture line.
Interventions
DEVICEconventional miniplates
conventional miniplates in double configuration
DEVICEInterFlex plates
InterFlex plates in configuration
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 InterFlex plates, and Group B with conventional miniplates
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patients with recent anterior mandibular fracture located between the mental foramina. * adults without gender predilection who agreed to follow-up, * fractures requiring open reduction and internal fixation, and * those medically fit for general anesthesia were included
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 | 3 months | Mean bone density at the fracture line was assessed using Cone-Beam Computed Tomography (CBCT) scan in Hounsfield Units (HU) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical evaluation for pain | six weeks | Pain was assessed using Visual Analogue Scale (VAS) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Clinical evaluation for Intra-fragmentary mobility | six weeks | Intra-fragmentary mobility was evaluated by bimanual palpation at the fracture site |
Countries
Egypt
Outcome results
None listed