Sagittal Split Plate Versus Two Miniplates in the Treatment of Mandibular Angle Fractures

July 29, 2025 updated by: Alexandria University

New Design Sagittal Split Plate Versus Two Miniplates in the Treatment of Mandibular Angle Fractures (Randomized Controlled Clinical Trial)

Mandibular fractures are the second most common maxillofacial fracture after nasal bone fracture. As a result, a lot of research work has gone into improving treatment methods for these fractures including, reduction of immobilization period and enhancement of rigid fixation. One of these modalities is the use of Sagittal Split plate at the angle of the mandible.

Study Overview

Status

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

Study Locations

  • Egypt
      • Alexandria, Egypt
        • Recruiting
        • Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University
        • Contact:
        • Principal Investigator:
          • Peter Naeem El Masry, BDS

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:

  • Patients suffering from recent, uninfected angle mandibular fracture.
  • Fracture that demands open reduction and internal fixation.

Exclusion Criteria:

  • Medically compromised patients contradicting the operation.
  • Existence of infection at the fracture line.
  • Pathological fracture.
  • An old 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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Test Group
Procedure: single Sagittal Split plate
patients will be treated using a single Sagittal Split plate at the neutral zone of mandible
Active Comparator: Conventional Group
Procedure: two conventional miniplates
patients will be treated using two conventional miniplates according to Champy's osteosynthesis lines.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in pain scores
Time Frame: baseline, 24 hours, 1 week, and 6 weeks
Will be assessed through a 10-point Visual Analogue Scale (VAS) (34). (0-1= None, 2-4= Mild, 5-7= Moderate, 8-10= Severe).
baseline, 24 hours, 1 week, and 6 weeks
Change in Maximal Inter-Incisal Mouth
Time Frame: baseline, 24 hours, 1 week, and 6 weeks
Using a millimeter ruler to measure maximal inter-incisal mouth opening
baseline, 24 hours, 1 week, and 6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative infection
Time Frame: 24 hours, 1 week, and 6 weeks
observation for any manifestations of wound healing disturbance
24 hours, 1 week, and 6 weeks
change in bone density
Time Frame: baseline and 12 weeks
Immediate CT (T0) scan will be done and then another CT (T1) will be taken at 12th week to estimate the mean bone density at the fracture line in comparison with the immediate postoperative scan
baseline and 12 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)

July 16, 2025

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

July 15, 2025

First Submitted That Met QC Criteria

July 29, 2025

First Posted (Actual)

August 5, 2025

Study Record Updates

Last Update Posted (Actual)

August 5, 2025

Last Update Submitted That Met QC Criteria

July 29, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1026-1/2025

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

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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