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Evaluation of Customized V Plate Versus Conventional Miniplates of Mandibular Angle Fracture

Primary Purpose

Mandibular Fractures

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Customized V plate fixation
Conventional miniplates fixation
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mandibular Fractures focused on measuring Angle fracture, superior-inferior plate fixation, custom made plate fixation, postoperative complications

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with at least a unilateral unfavorable angle fracture indicated for Open reduction internal fixation alone or in combination with fracture elsewhere in the mandible or midrace.
  • Patients should be free from any systemic disease that may affect normal healing of bone, and predictable outcome

Exclusion Criteria:

  • Patients with systemic disease (may affect normal healing).
  • Patients with old and/or malunited fractures (affect accuracy of reduction of the fractured segments).
  • Patients whom cannot tolerate follow up intervals (affect accuracy of study results).

Sites / Locations

  • Faculty of Dentistry-Cairo University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Customized V plate fixation

Conventional miniplates fixation

Arm Description

Computed tomography (CT) scan of the Facial bones (Axial cuts, DICOM file, Gantry tilt zero and minimal thickness of 1mm )is taken for the patients and a customized V pattern plate

Conventional superior-inferior miniplates fixation of mandibular angle fixation

Outcomes

Primary Outcome Measures

Mouth Opening
Mouth Opening is evaluated by measurement of maximal interincisal opening between maxilaary and mandibular central incisiors by the caliper and measuring unit is mm
Radiographical parameters
Radiographical parameters (Bone Density) is detected through CT scan to evaluate bone density in Hounsfield unit in the area of plate fixation to determine the effect of the plate stress over the fracture site Measures format will be summarized as mean

Secondary Outcome Measures

Occlusion
Occlusion will be evaluated by intraoral examination and write in dental chart whether normal or abnormal occlusion

Full Information

First Posted
November 29, 2018
Last Updated
July 26, 2019
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT03761524
Brief Title
Evaluation of Customized V Plate Versus Conventional Miniplates of Mandibular Angle Fracture
Official Title
Evaluation of the Effect of Customized V Plate Fixation Versus a Conventional Superior -Inferior Miniplates Fixation of Mandibular Angle Fracture on Mouth Opening and Radiographical Parameters Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 2019 (Anticipated)
Primary Completion Date
August 2021 (Anticipated)
Study Completion Date
September 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The aim of the study to evaluate the effect of customized V pattern plate fixation versus a conventional superior-inferior mini plates fixation of mandibular angle fracture on mouth opening and radio graphical parameters.
Detailed Description
The mandibular angle is one of the most common sites for fractures, accounting for 23-42% of all cases of mandibular fractures. Moreover, mandibular angle fractures have the highest postoperative complications among all mandibular fractures, and the loosening of screws and fracturing of plates are main reasons for the complications.The most widely used treatment modality for mandibular angle fracture is the use of one miniplate fixation ,The other one uses two mini-plates, with a upper mini-plate fixed at the same place of previous treatment which corresponds to the tension band of the mandible, and the lower mini-plate fixed at the inferior border of the mandible which corresponds to the compression band of the mandible, however, based on recent experimental and clinical studies, the stability provided by the miniplate fixation of mandibular angle fractures has become a point of contention among surgeons .In order to decrease the need for plate removal, reduce the operative time and improve the stability of the fixation system, a customized V pattern plate design is an appropriate plate structure for fractured mandible using the minimum output values for stress of plate and displacement of bony segments to seek maximum reduction volume on an original plate .Patient satisfaction include: clinical parameters such are occlusion, pain, facial swelling, maximal mouth opening, sensory function, and surgical wound ,these should be evaluated postoperatively ,radio graphical evaluation is also an important parameter to assess adequate reduction of the fractured segments .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mandibular Fractures
Keywords
Angle fracture, superior-inferior plate fixation, custom made plate fixation, postoperative complications

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Because the two interventions used in this trial are easily recognized by the participants and the investigator, neither the investigator nor the participant can be blinded. But, assessor and the statistician will be blinded.
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Customized V plate fixation
Arm Type
Experimental
Arm Description
Computed tomography (CT) scan of the Facial bones (Axial cuts, DICOM file, Gantry tilt zero and minimal thickness of 1mm )is taken for the patients and a customized V pattern plate
Arm Title
Conventional miniplates fixation
Arm Type
Active Comparator
Arm Description
Conventional superior-inferior miniplates fixation of mandibular angle fixation
Intervention Type
Procedure
Intervention Name(s)
Customized V plate fixation
Intervention Description
(CT) scan is taken for the patients and a customized V pattern plate will be designed .Intraoral approach will be done to expose the angle fracture.Fracture site will be exposed and reduced in normal anatomic position guided by the CAD/CAM plate. MMF will be done.Fracture fragments will be fixed using CAD/CAM plate .
Intervention Type
Procedure
Intervention Name(s)
Conventional miniplates fixation
Intervention Description
Intraoral approach will be done to expose the angle fracture.Fracture site will be exposed and reduced in normal anatomic position. MMF will be done.Fracture fragments will be fixed using conventional miniplates fixation of angle fracture.
Primary Outcome Measure Information:
Title
Mouth Opening
Description
Mouth Opening is evaluated by measurement of maximal interincisal opening between maxilaary and mandibular central incisiors by the caliper and measuring unit is mm
Time Frame
Every week for 1 month ,3 months and 6 months postoperative
Title
Radiographical parameters
Description
Radiographical parameters (Bone Density) is detected through CT scan to evaluate bone density in Hounsfield unit in the area of plate fixation to determine the effect of the plate stress over the fracture site Measures format will be summarized as mean
Time Frame
At 3 and 6 months postoperatively
Secondary Outcome Measure Information:
Title
Occlusion
Description
Occlusion will be evaluated by intraoral examination and write in dental chart whether normal or abnormal occlusion
Time Frame
immediate postoperative day

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with at least a unilateral unfavorable angle fracture indicated for Open reduction internal fixation alone or in combination with fracture elsewhere in the mandible or midrace. Patients should be free from any systemic disease that may affect normal healing of bone, and predictable outcome Exclusion Criteria: Patients with systemic disease (may affect normal healing). Patients with old and/or malunited fractures (affect accuracy of reduction of the fractured segments). Patients whom cannot tolerate follow up intervals (affect accuracy of study results).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hiba O Saleh, Phd.student
Phone
00201010389391
Email
dr.hiba2013@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hiba O Saleh, Phd.student
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Dentistry-Cairo University
City
Cairo
ZIP/Postal Code
11599
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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Evaluation of Customized V Plate Versus Conventional Miniplates of Mandibular Angle Fracture

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