Assessment of Condylar Position With Management of Unilateral Mandibular Angle Fracture

October 2, 2026 updated by: yara mamdouh mustafa, Cairo University

Assessment of Condylar Position With Management of Unilateral Mandibular Angle Fracture Using Patient Specific Angle Plate Versus Two Mini Plates (Randomized Clinical Trial)

The objective of this study is to assess condylar position and occlusion after open reduction and internal fixation using two miniplates versus patient specific plate

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Accordingly, this trial will be held using self-positioning specific plate to overcome such problems of the two-point fixation of mini plates : 1. The virtual planning and with aid of plate wings minimize the need for intra-operative IMF during fixation stage.

2.The virtual planning and fabrication of self-seating wings (lips) of the patient-specific plate ensure the seating of the condyle and centric relation.

Finally, the PSP will make fracture the reduction more accurate and will offer a great advantage of reduction of the operative time .

Study Type

Interventional

Enrollment (Actual)

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
      • Giza, Egypt, 12613
        • oral and dental medicine Cairo 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

17 years to 60 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria

1. Patients with a unilateral angle fracture indicated for Open reduction internal Fixation alone or in combination with fracture elsewhere in the mandible.

3. Patients should be free from any systemic disease that may affect normal healing of the bone.

4. Patients with good general condition allowing major surgical procedure under general anesthesia.

5. Patients with physical and psychological tolerance No history of previous surgical intervention in the angle site

Exclusion criteria :

  1. Patients with high risk systemic diseases like uncontrolled diabetes mellitus. as uncontrolled diabetes mellitus has a negative impact on normal bone healing
  2. Patients with old and/or mal-union fractures. As they will affect accuracy of reduction of the fractured segments.
  3. Patients with physical and psychological intolerance. As psychological stress will affect the immune system and patient's fitness including healing capacity

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 treated by two mini plates

patient fixed by 2 mini plates
Procedure: 2 mini plates

patients with mandibular angle fractures fixed by 2 mini plates
Experimental: fixation with patient specific plate

the Patient specific plate will make fracture the reduction more accurate and will offer a great advantage of reduction of the operative time
Procedure: patient specific plates

Angle fracture will be fixed by patient specific plates customized for him

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of condylar position (Linear displacement)
Time Frame: 3 months

Linear displacement (inter condylar distance) with computed tomography in millimeters
3 months
Assessment of condylar position (Angular displacement)
Time Frame: 3 months

Angular displacement with specialized software in degrees
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
assessment of occlusion
Time Frame: 3 months

Assessed by clinical photographs (Binary)
3 months

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)

August 25, 2025

Primary Completion (Actual)

November 25, 2025

Study Completion (Actual)

December 25, 2025

Study Registration Dates

First Submitted

September 28, 2026

First Submitted That Met QC Criteria

October 2, 2026

First Posted (Actual)

October 5, 2026

Study Record Updates

Last Update Posted (Actual)

October 5, 2026

Last Update Submitted That Met QC Criteria

October 2, 2026

Last Verified

October 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • omfs3-3-19

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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