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Mandibular Fracture Reduction Using Bone Reduction Forceps

Primary Purpose

Mandibular Fractures

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Bone reducion forceps
Sponsored by
Hams Hamed Abdelrahman
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mandibular Fractures

Eligibility Criteria

20 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Bone reduction forceps

Arm Description

Outcomes

Primary Outcome Measures

Change in radiodensitometric measurements
cone-beam computerized tomograms (CBCT) used to analyze the mean bone density at the site of fracture
change in maximal mouth opening
maximal interincisal opening between maxillary and mandibular central incisors.
change in occlusion
Any occlusal disturbance including open bite or improper tooth contact will be recorded
change in pain level
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)

Secondary Outcome Measures

Full Information

First Posted
June 20, 2020
Last Updated
June 20, 2020
Sponsor
Hams Hamed Abdelrahman
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1. Study Identification

Unique Protocol Identification Number
NCT04443998
Brief Title
Mandibular Fracture Reduction Using Bone Reduction Forceps
Official Title
Evaluation of Bone Reduction Forceps in Reducing Mandibular Fracture
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 16, 2019 (Actual)
Primary Completion Date
August 18, 2020 (Anticipated)
Study Completion Date
September 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Hams Hamed Abdelrahman

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mandibular Fractures

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bone reduction forceps
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Bone reducion forceps
Intervention Description
Repositioning forceps provide a more accurate anatomical reduction and higher pre-compression can be achieved compared to IMF or manual reduction
Primary Outcome Measure Information:
Title
Change in radiodensitometric measurements
Description
cone-beam computerized tomograms (CBCT) used to analyze the mean bone density at the site of fracture
Time Frame
at 3rd, 6th months
Title
change in maximal mouth opening
Description
maximal interincisal opening between maxillary and mandibular central incisors.
Time Frame
1 week, 2 weeks, 1 month, 6 weeks, and 3 months
Title
change in occlusion
Description
Any occlusal disturbance including open bite or improper tooth contact will be recorded
Time Frame
1 week, 2 weeks, 1 month, 6 weeks, and 3 months
Title
change in pain level
Description
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)
Time Frame
1 week, 2 weeks, 1 month, 6 weeks, and 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University, Egypt
City
Alexandria
State/Province
Azarita
ZIP/Postal Code
00203
Country
Egypt

12. IPD Sharing Statement

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Mandibular Fracture Reduction Using Bone Reduction Forceps

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