InterFlex Plate Versus Conventional Miniplates in the Management of Anterior Mandibular Fractures. a Randomized Controlled Clinical Trial
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Alexandria University
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- Radiographic evaluation for the assessment of mean bone density at the fracture line
Study Overview
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.
Study Design
- Study Type
- Interventional
- 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 Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Patients with anterior mandibular fracture managed with conventional miniplates
Patients with anterior mandibular fracture managed with conventional miniplates
Intervention: conventional miniplates (Device)
Patients with anterior mandibular fracture managed with InterFlex plates
Patients with anterior mandibular fracture managed with InterFlex plates
Intervention: InterFlex plates (Device)
Outcomes
Primary Outcomes
Radiographic evaluation for the assessment of mean bone density at the fracture line
Time Frame: 3 months
Mean bone density at the fracture line was assessed using Cone-Beam Computed Tomography (CBCT) scan in Hounsfield Units (HU)
Secondary Outcomes
- Clinical evaluation for pain(six weeks)