Evaluation of Condylar Position After Anterior Mandibular Fracture Fixation Using Plates Versus Headless Compression Screws (fracture)

September 12, 2026 updated by: Ahmed Mohamed Samy Ismail, Cairo University

Comparative Evaluation of Condylar Position Following Anterior Mandibular Fracture Fixation Using Conventional Plates Versus Headless Compression Screws: A Randomized Clinical Trial

This study compares two methods for fixing fractures of the front part of the lower jaw:

Conventional plates and screws Headless compression screws

Patients are randomly assigned to one of the two treatment groups. Researchers will use imaging to see whether either method causes a significant change in the position of the mandibular condyles, which are the parts of the jaw that connect to the jaw joints.

Why it matters: Proper condylar position is important for normal jaw movement, chewing, and overall TMJ function.

Main goal: To determine whether conventional plates or headless compression screws provide better preservation of condylar position after surgery.

The study may help surgeons choose the most appropriate fixation technique for patients with anterior mandibular fractures.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

16

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 Contact

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

Yes

Description

Inclusion Criteria:

  • Adult patients of age from 18 years or older, irrespective of the gender.
  • Recent single isolated anterior mandibular fracture (symphyseal or parasymphyseal) indicated for open reduction and internal fixation.
  • Dentate or partially dentate patients.

Exclusion Criteria:

  • Comminuted fractures.
  • Medically compromised patients contradicting surgical intervention under general anaesthesia.
  • Patients younger than 18 years.
  • Completely edentulous patients.

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: control
Device: conventional plates
Conventional plate-and-screw fixation has long been considered the standard treatment modality for anterior mandibular fractures. However, plate fixation may induce transverse mandibular widening or narrowing due to plate adaptation forces, screw placement, and limited interfragmentary compression
Experimental: intervention
Device: headless compression screw
Headless compression screws provide interfragmentary compression along the long axis of the mandible while maintaining a low-profile fixation system. Their design allows stable fixation with minimal hardware bulk and may reduce unwanted transverse displacement of fracture segments.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
intercondylar angle
Time Frame: Postoperative (within one week) and after 3 months
Postoperative (within one week) and after 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 (Estimated)

September 1, 2026

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

April 1, 2027

Study Registration Dates

First Submitted

September 12, 2026

First Submitted That Met QC Criteria

September 12, 2026

First Posted (Actual)

September 17, 2026

Study Record Updates

Last Update Posted (Actual)

September 17, 2026

Last Update Submitted That Met QC Criteria

September 12, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • 2911

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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