Patient Specific 3d Titanium Plate Versus Standard Two Mini Plates in the Fixation of Mandibular Angle Fractures (a Randomized Controlled Clinical Trial)

January 29, 2026 updated by: Alexandria University
To compare the effectiveness of custom-made (3D) titanium plates to standard two titanium mini plates in fixation of mandibular angle fracture.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Eighteen patients with mandibular angle fractures will be selected. In nine fractures, custom-made three dimensional titanium plates will be used for fracture fixation (study group); while in the other nine, conventional two mini plates will be used (control group),via intra oral approach (combined with transbuccal approach) for both groups. Patients will be evaluated clinically, and radiographically (immediate and four months post operative) to evaluate the 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

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patients suffering from mandibular angle fracture indicated for open reduction and fixation.
  2. Non infected mandibular angle fractures present less than two weeks. 3. Good oral hygiene.

Exclusion Criteria:

  1. Medically compromised patients contradicting operation (ASA III, IV & V).
  2. Patients receiving radiotherapy or chemotherapy. 3- Bone diseases (Osteoporosis, Osteopetrosis, Osteomalacia…etc.) 4- Pathological fracture. 5- Old untreated fracture.

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: patients with recent mandibular angle fractures managed with custom-made 3D titanium plates
patients that will undergo internal fixation with custom-made 3D titanium plates through intaoral and transbuccal approach .
Device: custom-made 3D titanium plates
custom-made 3D titanium plates through intaoral and transbuccal approach .
Experimental: patients with recent mandibular angle fractures managed with standared two mini plates
patient that will undergo internal fixation with standared two mini plates through intaoral and transbuccal approach.
Device: standared two mini plates
internal fixation with standared two mini plates through intaoral and transbuccal approach.

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: 4 months
Mean bone density at the fracture line was assessed using Computed Tomography (CT) scan in Hounsfield Units (HU)
4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post operative pain
Time Frame: 3 months
- Post operative pain This will be subjectively evaluated with a visual analogue scale (VAS) with values from 0 (no pain) to 10 (strongest pain).
3 months

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, 2025

Primary Completion (Actual)

December 30, 2025

Study Completion (Estimated)

April 30, 2026

Study Registration Dates

First Submitted

January 29, 2026

First Submitted That Met QC Criteria

January 29, 2026

First Posted (Actual)

February 5, 2026

Study Record Updates

Last Update Posted (Actual)

February 5, 2026

Last Update Submitted That Met QC Criteria

January 29, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1023-01/2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

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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