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

Phase 4

Completed

• Conditions: Anterior Mandibular Fracture

• Registration Number: NCT06740292
• Lead Sponsor: Alexandria University

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 Timeline

• Study Start: 2024-01-25
• Status Verified: 2024-12
• Primary Completion: 2024-12-01
• Study Completion: 2024-12-01
• Study First Submitted: 2024-12-13
• Study First Submitted QC: 2024-12-14
• Last Update Submitted: 2024-12-14
• Study First Posted: 2024-12-18
• Last Update Posted: 2024-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Clinical evaluation for pain	six weeks	Pain was assessed using Visual Analogue Scale (VAS)

Trial Locations

Locations (1)

Faculty of Dentistry, Alexandria University; 🇪🇬 Alexandria, Egypt