Fixation of Mandibular Angle Fracture Using 3D Titanium Miniplate Versus Standard Two Plate Fixation

May 1, 2026 updated by: Ahmed jassim Ahmed alsubaya, Cairo University

Fixation of Mandibular Angle Fracture Using 3D Titanium Miniplate Versus Standard Two Plate Fixation a Randomized Clinical Trial

Hypothesis The investigators hypothesis that fixation of mandibular angle fractures using a 3D titanium miniplate will provide better occlusal bite force than intraoral fixation using the standard two-plate technique.

The investigators expect that this method will facilitate a faster recovery time for participants to regain baseline occlusion force.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

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
      • Cairo, Egypt
        • Faculty of oral and dental medicine ,cairo university , oral and maxillodical department

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

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • • Age from 20 to 50years.

    • Male .
    • Patients with mandibular angle fractures.

Exclusion Criteria:

  • • Patients with contraindication to general anesthesia

    • Patients with comminuted angle fractures.
    • Patients with relevant systemic diseases contraindicating surgery or affecting bone healing.
    • Patients with infected condyle and coronoid fractures.
    • Gun-shot injuries.
    • Edentulous fractures.
    • Pathological 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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: fixation using standard Two plate titanium.

Intervention Name: Two Standard plat titanium system . Intervention Type: Device

Assigned Intervention:

Fixation using two titanium miniplates. The first plate is placed at the inferior border of the mandible from the buccal side, fixed with bicortical screws engaging both cortices. The second plate is positioned ~5 mm superior or at the external oblique ridge, fixed with monocortical screws to avoid dental root injury.
Device: Two Standard Plate Fixation
Fixation using two titanium miniplates. One plate at the inferior border of the mandible with bicortical screws. Second plate ~5 mm above or at the external oblique ridge with monocortical screws.
Other Names:
  • two Titanium Miniplates Fixation ,Dual Miniplate Fixation ,Conventional Two-Plate Technique.
Device: 3D Titanium Miniplate (2.0 mm, 8-hole).
Single 2.0 mm 9-hole 3D titanium plate fixed with monocortical screws. Plate contoured with horizontal crossbars perpendicular and vertical struts parallel to fracture line. Screws placed diagonally first.
Other Names:
  • Single 3D Titanium Plate, 2.0 mm Thickness, 6-Hole Rectangular 6-Hole ,3D Titanium Miniplate 3D Contoured Titanium Plate, 2.0 mm, 6-Hole
Experimental: 3D titanium miniplate

Intervention Name: 3D Titanium Miniplate (2.0 mm, 8-hole) Intervention Type: Device

Assigned Intervention:

Fixation with a single rectangular 2.0 mm 9-hole 3D titanium miniplate. Two diagonally opposite monocortical screws placed first, followed by the remaining two. The plate is contoured with crossbars perpendicular and struts parallel to the fracture line. The upper crossbar is positioned subapically. Fixation is on the lateral cortex or external oblique ridge with proper adaptation.
Device: Two Standard Plate Fixation
Fixation using two titanium miniplates. One plate at the inferior border of the mandible with bicortical screws. Second plate ~5 mm above or at the external oblique ridge with monocortical screws.
Other Names:
  • two Titanium Miniplates Fixation ,Dual Miniplate Fixation ,Conventional Two-Plate Technique.
Device: 3D Titanium Miniplate (2.0 mm, 8-hole).
Single 2.0 mm 9-hole 3D titanium plate fixed with monocortical screws. Plate contoured with horizontal crossbars perpendicular and vertical struts parallel to fracture line. Screws placed diagonally first.
Other Names:
  • Single 3D Titanium Plate, 2.0 mm Thickness, 6-Hole Rectangular 6-Hole ,3D Titanium Miniplate 3D Contoured Titanium Plate, 2.0 mm, 6-Hole

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occlusal force
Time Frame: first day surgery , second visit 30 days , the last visit 120 days. .
use bite force measurement device . make patient bite to muser the force (, newton unit).
first day surgery , second visit 30 days , the last visit 120 days. .

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
maximal incisal opening.
Time Frame: first day surgery , second visit 30 days , the last visit 120 days. .

Ask the patient to open their mouth as wide as possible without feeling pain.

Using a ruler or caliper, measure the vertical distance between the incisal edge of the upper central incisor and the incisal edge of the lower central incisor
first day surgery , second visit 30 days , the last visit 120 days. .
Patient satisfaction
Time Frame: first day surgery , second visit 30 days , the last visit 120 days. .
will be measured on a visual analogue scale (VAS) with zero being unsatisfied and ten being satisfied and happy .
first day surgery , second visit 30 days , the last visit 120 days. .

Collaborators and Investigators

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

Sponsor

Cairo 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, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

November 30, 2026

Study Registration Dates

First Submitted

June 10, 2025

First Submitted That Met QC Criteria

May 1, 2026

First Posted (Actual)

May 8, 2026

Study Record Updates

Last Update Posted (Actual)

May 8, 2026

Last Update Submitted That Met QC Criteria

May 1, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • angle frcture ,Truma

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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