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Comparative Study Evaluating Stability of Fracture Segments After Treatment of Mandibular Angle Fracture With 3d Strut Plate With or Without IMMF.

Primary Purpose

Mandible Fracture

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
3d strut plate.
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 3d strut plate, mandibular angle fracture

Eligibility Criteria

15 Years - 60 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients with mandibular angle fracture with or witout other fracture indicated for Open reduction internal fixation in the mandible.
  • Patient over 15 years old age and both sexes were included in this study.
  • Patients should be free from any systemic disease that may affect normal healing of bone, and predictable outcome.
  • Patients with good general condition allowing major surgical procedure under general anesthesia.
  • Patients with physical and psychological tolerance.

Exclusion Criteria:

  • Patients with comminuted fractures as it is not indicated for compression osteosynthesis like3d strut plate .
  • Patients with high risk systemic diseases like uncontrolled diabetes mellitus. As uncontrolled diabetes mellitus has a negative impact on normal bone healing.
  • Patients with old and/or mal-union fractures. As they will affect accuracy of reduction of the fractured segments.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    study group: 3d strut plate fixation without post op IMMF.

    control group: 3d srut plate fixation with post op IMMF.

    Arm Description

    Open reduction and internal fixation with 3d strut plate without post operative IMMF.

    Open reduction and internal fixation with 3d strut plate with post operative IMMF for 15 days.

    Outcomes

    Primary Outcome Measures

    stability of fracture segments.
    post operative bimanual manipulation of the fracture segment.

    Secondary Outcome Measures

    inferior alveolar nerve injury.
    measurment by:Neurosensory testing: patient will be asked if there was numbness without stimulus and on stroking the lower lip skin with afinger.The patient will be asked to grade the sensation present on an analog scale from 0 (no sensation) to 10 (completely normal sensation)
    Accuracy of fracture reduction.
    Post operative. Through computed tomography by measuring inter ramus distance using lingula as reference to measure.

    Full Information

    First Posted
    July 29, 2018
    Last Updated
    August 17, 2018
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03640039
    Brief Title
    Comparative Study Evaluating Stability of Fracture Segments After Treatment of Mandibular Angle Fracture With 3d Strut Plate With or Without IMMF.
    Official Title
    Comparative Study Evaluating Stability of Fracture Segments After Treatment of Mandibular Angle Fracture With 3d Strut Plate in Two Groups One With IMMF and Anthor Without IMMF ;Randomized Clinical Trial.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 11, 2019 (Anticipated)
    Primary Completion Date
    March 1, 2020 (Anticipated)
    Study Completion Date
    June 1, 2020 (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
    comparative study evaluating stability of fracture segments in mandibular angle fracture with 3d strut plate with or with out post operative IMMF.
    Detailed Description
    Two group of patient with mandibular angle fracture indicated for open reduction and internal fixation ,first group will be fixed with 3d stut plate with post operative IMMF. Second group will be fixed with 3d strut plate with out post operative IMMF. Eligble patients will be randomised in equal proportions between study group (3d strut plate with out post operative IMMF) and control group (3d strut plate with post operative IMMF). A- 3D strut plate without post operative IMMF: Pre operative computed tomography will be done for patient. Intra operative :all cases will under go general anathesia. Exposure of the fracture segments using vestubular incision. Inter-maxillary fixation will be done. The fracture segment will be reduced in normal anatomic postion guided with occlusion. The fracture segment will be fixed in postion using 3d srut plate. Closure of surgical incision. Post operative computed tomograghy will be done for the patient. Patient will be dismissed from operation room without IMMF. B- 3D strut with post operative IMMF: Pre operative computed tomography will be done for patient. Intra operative :all cases will under go general anathesia. Exposure of the fracture segments using vestubular incision. Inter-maxillary fixation will be done. The fracture segment will be reduced in normal anatomic postion guided with occlusion. The fracture segment will be fixed in postion using 3d srut plate. Closure of surgical incision. Post operative computed tomograghy will be done for the patient. Patient will be dismissed from operation room with IMMF for 15 days. Follow up for both groups : Clinical examination will be done at first week post operative and patients will be examined every week for one month. Last follow up visit will be after three months post operative.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Mandible Fracture
    Keywords
    3d strut plate, mandibular angle fracture

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    A Radomized clinical trial. Parallel group study. A trial will be carried out in hospital of oral and maxillofacial surgery department - faculty of dentistry cairo university. Equal randomization: participants with equal probabilities for intervention. Positive controlled: both groups receiving treatment.
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    16 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    study group: 3d strut plate fixation without post op IMMF.
    Arm Type
    Experimental
    Arm Description
    Open reduction and internal fixation with 3d strut plate without post operative IMMF.
    Arm Title
    control group: 3d srut plate fixation with post op IMMF.
    Arm Type
    Active Comparator
    Arm Description
    Open reduction and internal fixation with 3d strut plate with post operative IMMF for 15 days.
    Intervention Type
    Procedure
    Intervention Name(s)
    3d strut plate.
    Intervention Description
    Under general anathesia fracture will be exposed and fixed with 3d srut plate.Wound closed in standered fashion. patient will be released from operating room with out IMMF.
    Primary Outcome Measure Information:
    Title
    stability of fracture segments.
    Description
    post operative bimanual manipulation of the fracture segment.
    Time Frame
    15 days post operative.
    Secondary Outcome Measure Information:
    Title
    inferior alveolar nerve injury.
    Description
    measurment by:Neurosensory testing: patient will be asked if there was numbness without stimulus and on stroking the lower lip skin with afinger.The patient will be asked to grade the sensation present on an analog scale from 0 (no sensation) to 10 (completely normal sensation)
    Time Frame
    pre operative and 1 week post operative.
    Title
    Accuracy of fracture reduction.
    Description
    Post operative. Through computed tomography by measuring inter ramus distance using lingula as reference to measure.
    Time Frame
    one week post operative.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    15 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patients with mandibular angle fracture with or witout other fracture indicated for Open reduction internal fixation in the mandible. Patient over 15 years old age and both sexes were included in this study. Patients should be free from any systemic disease that may affect normal healing of bone, and predictable outcome. Patients with good general condition allowing major surgical procedure under general anesthesia. Patients with physical and psychological tolerance. Exclusion Criteria: Patients with comminuted fractures as it is not indicated for compression osteosynthesis like3d strut plate . Patients with high risk systemic diseases like uncontrolled diabetes mellitus. As uncontrolled diabetes mellitus has a negative impact on normal bone healing. Patients with old and/or mal-union fractures. As they will affect accuracy of reduction of the fractured segments.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mohamed T khater, MSc
    Phone
    +201003854552
    Email
    m_khater385@yahoo.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hesham A Hakam, Prof
    Organizational Affiliation
    Cairo University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    6503575
    Citation
    Kellman RM. Repair of mandibular fractures via compression plating and more traditional techniques: a comparison of results. Laryngoscope. 1984 Dec;94(12 Pt 1):1560-7.
    Results Reference
    background
    PubMed Identifier
    25232835
    Citation
    Saman M, Kadakia S, Ducic Y. Postoperative maxillomandibular fixation after open reduction of mandible fractures. JAMA Facial Plast Surg. 2014 Nov-Dec;16(6):410-3. doi: 10.1001/jamafacial.2014.543.
    Results Reference
    background
    PubMed Identifier
    15690289
    Citation
    Guimond C, Johnson JV, Marchena JM. Fixation of mandibular angle fractures with a 2.0-mm 3-dimensional curved angle strut plate. J Oral Maxillofac Surg. 2005 Feb;63(2):209-14. doi: 10.1016/j.joms.2004.03.018.
    Results Reference
    background
    PubMed Identifier
    8755408
    Citation
    Farmand M. [Experiences with the 3-D miniplate osteosynthesis in mandibular fractures]. Fortschr Kiefer Gesichtschir. 1996;41:85-7. German.
    Results Reference
    background
    PubMed Identifier
    22809633
    Citation
    Vineeth K, Lalitha RM, Prasad K, Ranganath K, Shwetha V, Singh J. "A comparative evaluation between single noncompression titanium miniplate and three dimensional titanium miniplate in treatment of mandibular angle fracture"--a randomized prospective study. J Craniomaxillofac Surg. 2013 Mar;41(2):103-9. doi: 10.1016/j.jcms.2012.05.015. Epub 2012 Jul 17.
    Results Reference
    background
    PubMed Identifier
    1475603
    Citation
    Farmand M, Dupoirieux L. [The value of 3-dimensional plates in maxillofacial surgery]. Rev Stomatol Chir Maxillofac. 1992;93(6):353-7. French.
    Results Reference
    background
    PubMed Identifier
    24205475
    Citation
    Sadhwani BS, Anchlia S. Conventional 2.0 mm miniplates versus 3-D plates in mandibular fractures. Ann Maxillofac Surg. 2013 Jul;3(2):154-9. doi: 10.4103/2231-0746.119231.
    Results Reference
    background
    PubMed Identifier
    20417012
    Citation
    Jain MK, Manjunath KS, Bhagwan BK, Shah DK. Comparison of 3-dimensional and standard miniplate fixation in the management of mandibular fractures. J Oral Maxillofac Surg. 2010 Jul;68(7):1568-72. doi: 10.1016/j.joms.2009.07.083. Epub 2010 Apr 22.
    Results Reference
    background

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    Comparative Study Evaluating Stability of Fracture Segments After Treatment of Mandibular Angle Fracture With 3d Strut Plate With or Without IMMF.

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