Comparative Study Evaluating Stability of Fracture Segments After Treatment of Mandibular Angle Fracture With 3d Strut Plate With or Without IMMF.

August 17, 2018 updated by: Mohamed Khater tarek, Cairo University

Comparative Study Evaluating Stability of Fracture Segments After Treatment of Mandibular Angle Fracture With 3d Strut Plate in Two Groups One With IMMF and Anthor Without IMMF ;Randomized Clinical Trial.

comparative study evaluating stability of fracture segments in mandibular angle fracture with 3d strut plate with or with out post operative IMMF.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Two group of patient with mandibular angle fracture indicated for open reduction and internal fixation ,first group will be fixed with 3d stut plate with post operative IMMF. Second group will be fixed with 3d strut plate with out post operative IMMF.

Eligble patients will be randomised in equal proportions between study group (3d strut plate with out post operative IMMF) and control group (3d strut plate with post operative IMMF).

A- 3D strut plate without post operative IMMF:

  • Pre operative computed tomography will be done for patient.
  • Intra operative :all cases will under go general anathesia.
  • Exposure of the fracture segments using vestubular incision.
  • Inter-maxillary fixation will be done.
  • The fracture segment will be reduced in normal anatomic postion guided with occlusion.
  • The fracture segment will be fixed in postion using 3d srut plate.
  • Closure of surgical incision.
  • Post operative computed tomograghy will be done for the patient.
  • Patient will be dismissed from operation room without IMMF.

B- 3D strut with post operative IMMF:

  • Pre operative computed tomography will be done for patient.
  • Intra operative :all cases will under go general anathesia.
  • Exposure of the fracture segments using vestubular incision.
  • Inter-maxillary fixation will be done.
  • The fracture segment will be reduced in normal anatomic postion guided with occlusion.
  • The fracture segment will be fixed in postion using 3d srut plate.
  • Closure of surgical incision.
  • Post operative computed tomograghy will be done for the patient.
  • Patient will be dismissed from operation room with IMMF for 15 days.

Follow up for both groups :

Clinical examination will be done at first week post operative and patients will be examined every week for one month. Last follow up visit will be after three months post operative.

Study Type

Interventional

Enrollment (Anticipated)

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

15 years to 60 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with mandibular angle fracture with or witout other fracture indicated for Open reduction internal fixation in the mandible.
  • Patient over 15 years old age and both sexes were included in this study.
  • Patients should be free from any systemic disease that may affect normal healing of bone, and predictable outcome.
  • Patients with good general condition allowing major surgical procedure under general anesthesia.
  • Patients with physical and psychological tolerance.

Exclusion Criteria:

  • Patients with comminuted fractures as it is not indicated for compression osteosynthesis like3d strut plate .
  • Patients with high risk systemic diseases like uncontrolled diabetes mellitus. As uncontrolled diabetes mellitus has a negative impact on normal bone healing.
  • Patients with old and/or mal-union fractures. As they will affect accuracy of reduction of the fractured segments.

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: study group: 3d strut plate fixation without post op IMMF.
Open reduction and internal fixation with 3d strut plate without post operative IMMF.
Procedure: 3d strut plate.
Under general anathesia fracture will be exposed and fixed with 3d srut plate.Wound closed in standered fashion. patient will be released from operating room with out IMMF.
Active Comparator: control group: 3d srut plate fixation with post op IMMF.
Open reduction and internal fixation with 3d strut plate with post operative IMMF for 15 days.
Procedure: 3d strut plate.
Under general anathesia fracture will be exposed and fixed with 3d srut plate.Wound closed in standered fashion. patient will be released from operating room with out IMMF.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
stability of fracture segments.
Time Frame: 15 days post operative.
post operative bimanual manipulation of the fracture segment.
15 days post operative.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
inferior alveolar nerve injury.
Time Frame: pre operative and 1 week post operative.
measurment by:Neurosensory testing: patient will be asked if there was numbness without stimulus and on stroking the lower lip skin with afinger.The patient will be asked to grade the sensation present on an analog scale from 0 (no sensation) to 10 (completely normal sensation)
pre operative and 1 week post operative.
Accuracy of fracture reduction.
Time Frame: one week post operative.
Post operative. Through computed tomography by measuring inter ramus distance using lingula as reference to measure.
one week post operative.

Collaborators and Investigators

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

Sponsor

Cairo University

Investigators

  • Study Director: Hesham A Hakam, Prof, Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Anticipated)

January 11, 2019

Primary Completion (Anticipated)

March 1, 2020

Study Completion (Anticipated)

June 1, 2020

Study Registration Dates

First Submitted

July 29, 2018

First Submitted That Met QC Criteria

August 17, 2018

First Posted (Actual)

August 21, 2018

Study Record Updates

Last Update Posted (Actual)

August 21, 2018

Last Update Submitted That Met QC Criteria

August 17, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2972018

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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