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

NCT06740292 | Completed Phase 4

• 1 other identifier: 0117-12/24
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Anterior Mandibular Fracture

Keywords

anterior mandibular fracture; symphyseal fracture; para-symphyseal fracture; InterFlex plate; functionally stabilized fixation; miniplate

Outcome Measures

Primary Outcomes (1)

• Radiographic evaluation for the assessment of mean bone density at the fracture line

  Mean bone density at the fracture line was assessed using Cone-Beam Computed Tomography (CBCT) scan in Hounsfield Units (HU)

  3 months

Secondary Outcomes (1)

• Clinical evaluation for pain

  six weeks

Other Outcomes (1)

• Clinical evaluation for Intra-fragmentary mobility

  six weeks

Study Arms (2)

Patients with anterior mandibular fracture managed with conventional miniplates

ACTIVE COMPARATOR

Patients with anterior mandibular fracture managed with conventional miniplates

Device: conventional miniplates

Patients with anterior mandibular fracture managed with InterFlex plates

EXPERIMENTAL

Patients with anterior mandibular fracture managed with InterFlex plates

Device: InterFlex plates

Interventions

conventional miniplates DEVICE

conventional miniplates in double configuration

Patients with anterior mandibular fracture managed with conventional miniplates

InterFlex plates DEVICE

InterFlex plates in configuration

Patients with anterior mandibular fracture managed with InterFlex plates

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• medically compromised patients,
• fractures with infection,
• pathological or old fractures,
• completely edentulous patients,
• comminuted fractures

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Faculty of Dentistry, Alexandria University

Alexandria, Alexandria Governorate, 21523, Egypt

Location

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2024
• First Posted: December 18, 2024
• Study Start: January 25, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: December 18, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Access Criteria: to any one who required them after deidentification

Locations

EG (1)