3D Interlocking Miniplates in Fixation of Mandibular Fractures in the Mental Foramen Region: A Split-mouth Study

Phase 4

Completed

• Conditions: Mandibular Fractures; Miniplate

• Registration Number: NCT06939010
• Lead Sponsor: Alexandria University

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

Study Timeline

• Study Start: 2023-01-01
• Primary Completion: 2024-08-01
• Study Completion: 2024-12-01
• Status Verified: 2025-04
• Study First Submitted: 2025-04-15
• Study First Submitted QC: 2025-04-15
• Last Update Submitted: 2025-04-15
• Study First Posted: 2025-04-22
• Last Update Posted: 2025-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

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	12 weeks	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 Intra-fragmentary mobility	6 weeks	Intra-fragmentary mobility was evaluated by bimanual palpation at the fracture site

Trial Locations

Locations (1)

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