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

December 14, 2024 updated by: Alexandria University

InterFlex Plate Versus Conventional Miniplates in the Management of Anterior Mandibular Fractures. a Randomized Controlled Clinical Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Alexandria, Egypt, 21523
        • Faculty of Dentistry, Alexandria University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Patients with anterior mandibular fracture managed with conventional miniplates
Device: conventional miniplates
conventional miniplates in double configuration
Experimental: Patients with anterior mandibular fracture managed with InterFlex plates
Device: InterFlex plates
InterFlex plates in configuration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical evaluation for pain
Time Frame: six weeks
Pain was assessed using Visual Analogue Scale (VAS)
six weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical evaluation for Intra-fragmentary mobility
Time Frame: six weeks
Intra-fragmentary mobility was evaluated by bimanual palpation at the fracture site
six weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alexandria University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 25, 2024

Primary Completion (Actual)

December 1, 2024

Study Completion (Actual)

December 1, 2024

Study Registration Dates

First Submitted

December 13, 2024

First Submitted That Met QC Criteria

December 14, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 14, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0117-12/24

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

all data will be de-identified to protect the participant data. patients signed an informed consent for the use of their medical records and data for study

IPD Sharing Access Criteria

to any one who required them after deidentification

IPD Sharing Supporting Information Type

  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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