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Specific Screw Holes Locating Surgical Guide and Pre-bent Plates

Primary Purpose

Mandibular Fractures

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
specific screw holes locating surgical guide and pre-bent plates
classical reduction and internal fixation.
Sponsored by
Abdallah Gaber Ali Mohamed
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Mandibular Fractures focused on measuring class III

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients with delayed and isolated mandibular class III fracture needs open reduction and internal fixation.
  • Patients with medical history that did not hinder plate placement (uncontrolled diabetes) and adequate proper oral hygiene.
  • Both genders males and females will be included.

Exclusion Criteria:

  • • General contraindications to surgery.

    • Patients with fresh fractures (mobile segments).
    • Patients with unfavourable nor comminuted fractures.
    • Subjected to irradiation in the head and neck area less than 1 year before fixation.
    • Untreated periodontitis.
    • Poor oral hygiene and motivation.
    • Uncontrolled diabetes.
    • Pregnant or nursing.
    • Substance abuse.
    • Psychiatric problems or unrealistic expectations.
    • Severe bruxism or clenching.
    • Immunosuppressed or immunocompromised.
    • Treated or under treatment with intravenous amino-bisphosphonates.
    • Patients participating in other studies, if the present protocol could not be properly followed.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Other

    Arm Label

    specific screw holes locating surgical guide and pre-bent plates

    classical reduction and fixation

    Arm Description

    Put the specific screw holes locating device in place and drill the screw holes, remove the screw holes locating device and mobilize the segments then apply the pre-bent plates and fix it with screw for passive reduction of the segments. Then suture the mentalis muscle then the mucosa.

    mobilize the broken segment first, Arch bar was made to achieve proper occlusion put the compression plate on the inferior border and remove it for further bending using plate pliers for further accommodation of the plate on the inferior border the fix it in place using compression and tension plate.

    Outcomes

    Primary Outcome Measures

    computer tomography
    the Computer Tomography Will calculate the segments deviation in mm. after 3 month .

    Secondary Outcome Measures

    Full Information

    First Posted
    June 22, 2022
    Last Updated
    July 1, 2022
    Sponsor
    Abdallah Gaber Ali Mohamed
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05444829
    Brief Title
    Specific Screw Holes Locating Surgical Guide and Pre-bent Plates
    Official Title
    Precision of Patient Specific Screw Holes Locating Surgical Guide and Pre-bent Plates Osteosynthesis Versus Classical Work-flow in Management of Class III Mandibular Fractures
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 1, 2022 (Anticipated)
    Primary Completion Date
    July 2023 (Anticipated)
    Study Completion Date
    September 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Abdallah Gaber Ali Mohamed

    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
    The aim of the current study was to evaluate the accuracy of computer-guided mandibular fracture reduction versus the classical work flow
    Detailed Description
    Research question: Does the use of screw holes locating surgical guide & pre-bent plates osteosynthesis accurately reduce class III mandibular fractures regarding segments integrity and occlusion more than the classical reduction and fixation? Statement of the problem: Mandibular fractures are the most frequently occurring fractures within the maxillofacial injuries. The evaluation, diagnosis, and management of these fractures remain challenging despite improved imaging technology and fixation techniques. Depending on the type and location of the fractures, various open and closed surgical reduction techniques can be utilized. There are several critical and inherent limitations to the current ,standard approach of mandibular fracture reduction and fixation includes : (improper alignment of segments ,malocclusion ,nerve affections and related teeth roots injury). There is a possibility to overcome these limitations with the help of computer-guided surgery . The introduction of CAD/CAM software has provided surgeons with an opportunity to perform virtual manipulations of CT datasets preoperatively and production of corrected mandibular model for plate pre-bending and fabrication of plate locating surgical guide which provide accurate segment reduction and fixation with accurate post-operative occlusion and minimal post-operative complication . The aim of the current study was to evaluate the accuracy of computer-guided mandibular fracture reduction versus the conventional work flow Rationale for conducting the research: Through computer guided mandibular fracture reduction investigators can provide proper segment alignment with subsequent accurate post-operative occlusion in addition reduce intra-operative time , post-operative pain and edema

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    26 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    specific screw holes locating surgical guide and pre-bent plates
    Arm Type
    Experimental
    Arm Description
    Put the specific screw holes locating device in place and drill the screw holes, remove the screw holes locating device and mobilize the segments then apply the pre-bent plates and fix it with screw for passive reduction of the segments. Then suture the mentalis muscle then the mucosa.
    Arm Title
    classical reduction and fixation
    Arm Type
    Other
    Arm Description
    mobilize the broken segment first, Arch bar was made to achieve proper occlusion put the compression plate on the inferior border and remove it for further bending using plate pliers for further accommodation of the plate on the inferior border the fix it in place using compression and tension plate.
    Intervention Type
    Device
    Intervention Name(s)
    specific screw holes locating surgical guide and pre-bent plates
    Intervention Description
    Put the specific screw holes locating device in place and drill the screw holes, remove the screw holes locating device and mobilize the segments then apply the pre-bent plates and fix it with screw for passive reduction of the segments. Then suture the mentalis muscle then the mucosa.
    Intervention Type
    Device
    Intervention Name(s)
    classical reduction and internal fixation.
    Intervention Description
    mobilize the broken segment first, Arch bar was made to achieve proper occlusion put the compression plate on the inferior border and remove it for further bending using plate pliers for further accommodation of the plate on the inferior border the fix it in place using compression and tension plate.
    Primary Outcome Measure Information:
    Title
    computer tomography
    Description
    the Computer Tomography Will calculate the segments deviation in mm. after 3 month .
    Time Frame
    after 3 months

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patients with delayed and isolated mandibular class III fracture needs open reduction and internal fixation. Patients with medical history that did not hinder plate placement (uncontrolled diabetes) and adequate proper oral hygiene. Both genders males and females will be included. Exclusion Criteria: • General contraindications to surgery. Patients with fresh fractures (mobile segments). Patients with unfavourable nor comminuted fractures. Subjected to irradiation in the head and neck area less than 1 year before fixation. Untreated periodontitis. Poor oral hygiene and motivation. Uncontrolled diabetes. Pregnant or nursing. Substance abuse. Psychiatric problems or unrealistic expectations. Severe bruxism or clenching. Immunosuppressed or immunocompromised. Treated or under treatment with intravenous amino-bisphosphonates. Patients participating in other studies, if the present protocol could not be properly followed.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    abdallah gaber
    Phone
    01155778958
    Email
    abdallahgaber@dentistry.cu.edu.eg
    First Name & Middle Initial & Last Name or Official Title & Degree
    Hussein Hatem
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mohammed Omara
    Organizational Affiliation
    Cairo University
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    mona el hadidy
    Organizational Affiliation
    Cairo University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Links:
    URL
    https://pubmed.ncbi.nlm.nih.gov/24021623/
    Description
    Reginald H.B. Goodday/Management of Fractures of the Mandibular Body and Symphysis. Oral Maxillofacial Surg Clin North Am. 2013 Nov;25
    URL
    https://pubmed.ncbi.nlm.nih.gov/26163841/.
    Description
    Evaluation of the Accuracy of Computer-Guided Mandibular Fracture Reduction. 2015 Jul;26(5):1587-91.doi: 10.1097/SCS.0000000000001773.
    URL
    https://pubmed.ncbi.nlm.nih.gov/29710318/
    Description
    Parul Sinha , Gary Skolnick , Kamlesh B Patel , Gregory H Branham , John J Chi /A 3-Dimensional-Printed Short-Segment Template Prototype for Mandibular Fracture Repair. 2018 Sep 1;20(5):373-380
    URL
    https://pubmed.ncbi.nlm.nih.gov/28785906/
    Description
    Comparison of 3D plate and locking plate in treatment of mandibular fracture-a clinical study. Oral Maxillofacial Surg 2017 Dec;21(4)
    URL
    https://pubmed.ncbi.nlm.nih.gov/20537782/
    Description
    Scott Lovald , Bret Baack, Curtis Gaball, Garth Olson, Anna 31 Hoard/Biomechanical optimization of bone plates used in rigid fixation of mandibular symphysis fractures. 2010 Aug

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