Mandibular Fracture Reduction Using Bone Reduction Forceps

June 20, 2020 updated by: Hams Hamed Abdelrahman

Evaluation of Bone Reduction Forceps in Reducing Mandibular Fracture

Different methods have been used in reducing mandibular fractures. Bone reduction forceps provides precise reduction and stabilize mandibular fracture segments.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The aim of this study is to evaluate clinically and radiographically the effect of using bone reduction forceps in the reduction of isolated mandibular fractures.

10 patients complaining of isolated mandibular fractures in need of open reduction and internal fixation underwent reduction using bone reduction forceps.

The patients followed up clinically after 1 and 2 weeks, 1, 3, and 6 months postoperatively. Radiographic evaluation will be performed by computed tomography (CT) preoperatively, and cone-beam computed tomography (CBCT) will be done after 3 and 6 months

Study Type

Interventional

Enrollment (Actual)

10

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
    • Azarita
      • Alexandria, Azarita, Egypt, 00203
        • Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University, Egypt

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

20 years to 45 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria

  • Adult patients aged from 20 to 45 years will be included.
  • Patients suffered from recent and uninfected.
  • Patients with isolated mandibular fractures.

Exclusion criteria

  • Medically compromised patients that will be not fit for surgery.
  • Edentulous patients.
  • Non-displaced
  • Comminuted fracture with bone loss
  • Old fracture, more than 3 weeks

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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Bone reduction forceps
Device: Bone reducion forceps
Repositioning forceps provide a more accurate anatomical reduction and higher pre-compression can be achieved compared to IMF or manual reduction

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in radiodensitometric measurements
Time Frame: at 3rd, 6th months
cone-beam computerized tomograms (CBCT) used to analyze the mean bone density at the site of fracture
at 3rd, 6th months
change in maximal mouth opening
Time Frame: 1 week, 2 weeks, 1 month, 6 weeks, and 3 months
maximal interincisal opening between maxillary and mandibular central incisors.
1 week, 2 weeks, 1 month, 6 weeks, and 3 months
change in occlusion
Time Frame: 1 week, 2 weeks, 1 month, 6 weeks, and 3 months
Any occlusal disturbance including open bite or improper tooth contact will be recorded
1 week, 2 weeks, 1 month, 6 weeks, and 3 months
change in pain level
Time Frame: 1 week, 2 weeks, 1 month, 6 weeks, and 3 months
Pain: will be measured on Visual Analogue Scale (VAS). The patients will be asked to rate their postoperative pain on a 4-point scale (0= none, 1= slight, 2= moderate, 3- severe)
1 week, 2 weeks, 1 month, 6 weeks, and 3 months

Collaborators and Investigators

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

Sponsor

Hams Hamed Abdelrahman

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)

October 16, 2019

Primary Completion (ANTICIPATED)

August 18, 2020

Study Completion (ANTICIPATED)

September 1, 2020

Study Registration Dates

First Submitted

June 20, 2020

First Submitted That Met QC Criteria

June 20, 2020

First Posted (ACTUAL)

June 23, 2020

Study Record Updates

Last Update Posted (ACTUAL)

June 23, 2020

Last Update Submitted That Met QC Criteria

June 20, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Mandibular fracture reduction

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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