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

April 15, 2025 updated by: Alexandria University

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

the study aims to compare 3D Interlocking miniplates with conventional miniplates in management of mandibular parasymphyseal fractures both clinically and radiographically.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

12

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 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 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
Experimental: patient with bilateral fracture in the mental nerve region managed with 3D-interlocking miniplate
patient with bilateral fracture in the mental nerve region. one side will be randomly allocated to be managed with 3D-interlocking miniplate
Device: 3d-interlocking miniplate
3d-interlocking miniplate
Experimental: patient with bilateral fracture in the mental nerve region managed with conventional miniplates
patient with bilateral fracture in the mental nerve region. one side will be randomly allocated to be managed with conventional miniplates
Device: Conventional miniplates
double miniplates in the conventional 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: 12 weeks
Mean bone density at the fracture line was assessed using Cone-Beam Computed Tomography (CBCT) scan in Hounsfield Units (HU)
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical evaluation for Intra-fragmentary mobility
Time Frame: 6 weeks
Intra-fragmentary mobility was evaluated by bimanual palpation at the fracture site
6 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 1, 2023

Primary Completion (Actual)

August 1, 2024

Study Completion (Actual)

December 1, 2024

Study Registration Dates

First Submitted

April 15, 2025

First Submitted That Met QC Criteria

April 15, 2025

First Posted (Actual)

April 22, 2025

Study Record Updates

Last Update Posted (Actual)

April 22, 2025

Last Update Submitted That Met QC Criteria

April 15, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3D-Interlocking

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 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

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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