InterFlex Plate Versus Conventional Miniplates in the Management of Anterior Mandibular Fractures.

Alexandria University

Status and phase: Completed; Phase 4

Conditions: Anterior Mandibular Fracture

Treatments: Device: InterFlex plates; Device: conventional miniplates

Study type: Interventional

Funder types: Other

Identifiers

NCT06740292

0117-12/24

Details and patient eligibility

About

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.

Full 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.

Enrollment: 18 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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18 participants in 2 patient groups

Patients with anterior mandibular fracture managed with conventional miniplates

Active Comparator group

Description:

Patients with anterior mandibular fracture managed with conventional miniplates

Treatment:

Device: conventional miniplates

Patients with anterior mandibular fracture managed with InterFlex plates

Experimental group

Description:

Patients with anterior mandibular fracture managed with InterFlex plates

Treatment:

Device: InterFlex plates