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Stability of Angle Fracture Fixation With (K) Shaped Titanium Miniplates Versus Two Miniplates

Primary Purpose

Mandible Fracture

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
fixation of angle fracture
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mandible Fracture focused on measuring angle fracture

Eligibility Criteria

15 Years - 70 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Patients with unilateral angle fracture.
  2. Patients free from any systemic disease & bone metabolism diseases.
  3. No sex predilection
  4. Age range ( 15-70)

Exclusion Criteria:

  1. Comminuted fragmented & infected angle fractures.
  2. Bilateral angle fracture.
  3. Systemic diseases.
  4. bone metabolism diseases

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    K plate

    Conventional two miniplates

    Arm Description

    fixation of angle fracture using K plate versus two miniplates

    fixation of angle fracture using K plate versus two miniplates

    Outcomes

    Primary Outcome Measures

    Stability of angle fracture fixation
    Inter-ramus distance (fixed position at the lingual), inter-mental distance will be obtained from the immediate postoperative facial bone CT & after 3 months. Comparison between the 2 records will be done to assess the stability of fixation technique. Bone density will be measured by Hounsfield unit at fracture site immediate postoperative & after 3 months using F.B.CT.

    Secondary Outcome Measures

    Full Information

    First Posted
    February 11, 2019
    Last Updated
    June 1, 2019
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03839368
    Brief Title
    Stability of Angle Fracture Fixation With (K) Shaped Titanium Miniplates Versus Two Miniplates
    Official Title
    Stability of Angle Fracture Fixation With (K) Shaped Titanium Miniplates Versus Two Conventional Miniplates: Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 2020 (Anticipated)
    Primary Completion Date
    April 11, 2020 (Anticipated)
    Study Completion Date
    April 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
    No

    5. Study Description

    Brief Summary
    In patients with angle fracture , will the (K) shaped titanium miniplates provide more stable fixation than two conventional miniplates? Many studies have been conducted to compare between different techniques of fixation used in angle fracture fixation. The driving force behind this study was to design a new plate that would overcome the disadvantages of the other plating techniques but has the advantages & simplicity of the Champy technique (simple intraoral approach and few major complications). This new miniplate gives more biomechanical stability than the conventional Champy plate. More over the placement of a 3D miniplate or two separate miniplates for fixing angle fractures is more difficult and mostly will require a transbuccal approach , with increased surgical trauma, longer operation time unlike the new plate that could provide the clinician with a simple and reliable solution.
    Detailed Description
    In the past two decades, rigid internal fixation with miniplate has become the standard treatment modality in the management of mandibular fracture. The optimal management of mandibular angle fractures remains controversial, thus continuous experimental & clinical studies are being conducted to determine the best miniplate design which will provide the best postoperative stability & resistance to mechanical function. Since Michelet et al.& Champy et al. recommended the use of a single (4-6 holes) monocortical plate , it become an acceptable method for angle fractures fixation. Several surgeons have documented low complication rates with (Champy technique).But, according to the most recent experimental & clinical studies, the stability provided by the miniplate fixation has become a point of debate among surgeons.Many researchers have argued that internal fixation with a passive miniplate along the external oblique line, following Champy's ideal osteosynthesis line principle, produces a tension effect that may yield a failure of osteosynthesis & gap at inferior border of the mandible.And that pushed researches to conduct more studies to evaluate many plate & screw systems and even suggest new designs for better stable postoperative results. In 2014, B.T.Suer et al, designed a new noncompression 3D miniplates , basically it has one straight section and two lateral extensions. The straight section of this new design, which has four holes, was adapted to the superior border of the external oblique ridge & provides similar advantages to the Champy technique (an intraoral approach, a single miniplate, & the use of monocortical screws) .And the two lateral extensions, with one hole each, were then bent over to adapt to the buccal cortex of the ascending ramus along the external oblique ridge to resist lateral & torsional forces. Fresh, frozen cadavers of 15 healthy sheep were obtained for this study, sheep were used in this study owing to the similarities in size & thickness to the human mandible. All of the mandibles were stripped of their soft tissues & sectioned through the midline, between the central incisors. 30 hemimandibles were randomly divided into two groups , these groups were then fixed with two different plating techniques (the new design & one conventional miniplates). And they were all examined for stability and resistance to mechanical forces (vertical, lateral, or tensile). The driving force behind this study was to design a new plate that would overcome the disadvantages of the other plating techniques but has the advantages & simplicity of the Champy technique (simple intraoral approach and few major complications). This new miniplate gives more biomechanical stability than the conventional Champy plate. These findings are correlated to those of in vitro biomechanical study done by Alkan et al. that showed that Champy technique has less favourable biomechanical behaviour than biplanar fixation and 3D strut plate. In addition the new plate provide greater stability when subjected to lateral displacing forces. More over the placement of a 3D miniplate or two separate miniplates for fixing angle fractures is more difficult and mostly will require a transbuccal approach , with increased surgical trauma, longer operation time unlike the new plate that could provide the clinician with a simple and reliable solution.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Mandible Fracture
    Keywords
    angle fracture

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Randomized
    Masking
    Participant
    Masking Description
    Cards will have sequential numbers one number for each card then these cards will be placed within opaque sealed envelopes. Then these envelops will be placed in a container (box), each participant will grasp one envelope the day of procedure.
    Allocation
    Randomized
    Enrollment
    12 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    K plate
    Arm Type
    Experimental
    Arm Description
    fixation of angle fracture using K plate versus two miniplates
    Arm Title
    Conventional two miniplates
    Arm Type
    Active Comparator
    Arm Description
    fixation of angle fracture using K plate versus two miniplates
    Intervention Type
    Procedure
    Intervention Name(s)
    fixation of angle fracture
    Intervention Description
    open reduction and internal fixation of angle fracture
    Primary Outcome Measure Information:
    Title
    Stability of angle fracture fixation
    Description
    Inter-ramus distance (fixed position at the lingual), inter-mental distance will be obtained from the immediate postoperative facial bone CT & after 3 months. Comparison between the 2 records will be done to assess the stability of fixation technique. Bone density will be measured by Hounsfield unit at fracture site immediate postoperative & after 3 months using F.B.CT.
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    15 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patients with unilateral angle fracture. Patients free from any systemic disease & bone metabolism diseases. No sex predilection Age range ( 15-70) Exclusion Criteria: Comminuted fragmented & infected angle fractures. Bilateral angle fracture. Systemic diseases. bone metabolism diseases
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Hagar A Mohamed, BDS
    Phone
    01016799911
    Email
    hagar_elsherif92@yahoo.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hagar Mohamed, BDS
    Organizational Affiliation
    Cairo University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    24582290
    Citation
    Suer BT, Kocyigit ID, Kaman S, Tuz HH, Tekin U, Atil F. Biomechanical evaluation of a new design titanium miniplate for the treatment of mandibular angle fractures. Int J Oral Maxillofac Surg. 2014 Jul;43(7):841-5. doi: 10.1016/j.ijom.2014.01.011. Epub 2014 Feb 24.
    Results Reference
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    Stability of Angle Fracture Fixation With (K) Shaped Titanium Miniplates Versus Two Miniplates

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