Mandibular Fractures, Miniplate
Conditions
Keywords
Mental nerve, conventional miniplates, 3D Interlocking, mandibular parasymphyseal fracture
Brief summary
the study aims to compare 3D Interlocking miniplates with conventional miniplates in management of mandibular parasymphyseal fractures both clinically and radiographically.
Detailed description
A total of 12 patients with recent bilateral parasymphyseal mandibular fractures were treated with 3D Interlocking miniplates on one side and with conventional two miniplates in the other side. Clinical evaluations were carried at multiple intervals up to 6 weeks postoperatively, with radiographic assessments performed immediately after surgery and at 12 weeks to measure mean bone density at the fracture line
Interventions
DEVICE3d-interlocking miniplate
3d-interlocking miniplate
DEVICEConventional miniplates
double miniplates in the conventional configuration
Sponsors
Alexandria University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Masking description
Fracture sides 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 3D-interlocking miniplate in one side, and Group B with conventional double miniplates configration in the other side.
Intervention model description
Split-mouth
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patients with recent bilateral mandibular fracture located in the mental foramina region. * 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 | 12 weeks | 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 Intra-fragmentary mobility | 6 weeks | Intra-fragmentary mobility was evaluated by bimanual palpation at the fracture site |
Countries
Egypt
Outcome results
None listed