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Patient Satisfaction Vertical Ramus Osteotomy Patient Specificosteosynthesis Fixation Versus MMFmandibular Prognanthism

Primary Purpose

Mandibular Prognathism

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
customized fixation plate
maxillomandibular fixation
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mandibular Prognathism focused on measuring Mandibular Prognanthism,customized plate

Eligibility Criteria

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

Inclusion Criteria:

All subjects were required:

  • Patients with mandibular prognanthism indicated for mandibular setback.
  • All ages >18 years
  • Patients should be free from any systemic disease that may affect normal healing of bone, and predictable outcome.
  • Patients with good general condition allowing surgical procedure under general anesthesia.
  • Patients with physical and psychological tolerance

Exclusion Criteria:

  • History of mandibular trauma
  • Previous orthognathic surgery
  • Degenerative disease of temporomandibular joint
  • Craniofacial syndrome such as cleft lip or palate
  • Follow up period will be less than 6 months

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Customized plate fixation

    maxillomandibular fixation

    Arm Description

    Customized Plate fixation of Vertical Ramus Osteotomy after Mandibular Setback - intervention: All cases will undergo one surgery under general anesthesia. Incision was made medial to external oblique ridge from the asendindg ramus to second molar region The intraoral vertical osteotomy is accomplished by using an oscillating saw to make the cut from the sigmoid notch through the inferior border of the mandible. 3D virtual planning and 3D mandible model represented fom CBCT in MIMICS The customized fixation plate is positioned to fix the proximal and distal segment together

    Mandibular Setback by Vertical Ramus Ostotmy fixed with Maxillomandibular fixation - intervention: All cases will undergo one surgery under general anesthesia incision was made medial to external oblique ridge from the asendindg ramus to second molar region . The intraoral vertical osteotomy is accomplished by using an oscillating saw to make the cut from the sigmoid notch through the inferior border of the mandible. Patient is placed in maxillomandibular fixation (MMF) using a prefabricated occlusal splint

    Outcomes

    Primary Outcome Measures

    Patient Satisfaction
    Patient were asked to fill out a questionnaire in order to investigate their satisfaction degree after surgery ,according to an adapted (10 cm) visual analogue scale (VAS) from 0 to +10 0 is the least satisfied 10 is the most satisfied

    Secondary Outcome Measures

    stability of Mandible
    assessed by determining the differences between measurements of three mandibular reference points (B-point, menton, and pogonion) in relation to SNy ,SNx axis obtained at six different time points

    Full Information

    First Posted
    February 21, 2019
    Last Updated
    February 24, 2019
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03855072
    Brief Title
    Patient Satisfaction Vertical Ramus Osteotomy Patient Specificosteosynthesis Fixation Versus MMFmandibular Prognanthism
    Official Title
    Patient Satisfaction Following Vertical Ramus Osteotomy After Mandibular Setback Fixed With Patients Specific Osteosynthesis and Immediate Mobilization Versus Vertical Ramus Osteotomy Fixed With MMFin Patients With Mandibular Prognanthism
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 2019 (Anticipated)
    Primary Completion Date
    January 2022 (Anticipated)
    Study Completion Date
    August 2022 (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
    Two groups with mandibular prognanthism indicated for mandibular setback by intraoral vertical ramus osteotomy . first group will fixed with maxillomandibular fixation and the second group will fixed by customized plate
    Detailed Description
    Two groups with mandibular prognanthism indicated for mandibular setback by intraoral vertical ramus osteotomy . first group will fixed with maxillomandibular fixation and the second group will fixed by customized plate Interventions: General operative procedures Eligible patients will be randomized in equal proportions between the study group (customized plate fixation of VRO) and the control group (maxillomandibular fixation of VRO). Patients of Both groups will be subjected to: Case history including personal data, medical, surgical history and family history Clinical examination . Radiographic examination in the form of cephalometric radiogragh . Preoperative laboratory tests (complete blood cell count, Hemoglobin count, coagulation profile, liver function, kidney function and blood glucose level). Preoperative anesthesia assessment for fitness for general anesthesia. vertical ramus osteotmy fixed with customized plate All cases will undergo one surgery under general anesthesia. Incision was made medial to external oblique ridge from the asendindg ramus to second molar region Amucoperiosteal flap was reflected to expose the lateral mandibular ramus to the posterior border and the sigmoid notch The intraoral vertical osteotomy is accomplished by using an oscillating saw to make the cut from the sigmoid notch through the inferior border of the mandible. The osteotomy is placed 5 mm anterior to the posterior border of the mandible to avoid injury to the inferior alveolar neurovascular bundle 3D virtual planning and 3D mandible model represented fom CBCT in MIMICS The setback will be simulated according to pre-planned measure The customized bone plate is positioned to fix the proximal and distal segment together vertical ramus osteotomy fixed with MMF. All cases will undergo one surgery under general anesthesia. incision was made medial to external oblique ridge from the asendindg ramus to second molar region . Amucoperiosteal flap was reflected to expose the lateral mandibular ramus to the posterior border and the sigmoid notch The intraoral vertical osteotomy is accomplished by using an oscillating saw to make the cut from the sigmoid notch through the inferior border of the mandible. The osteotomy is placed 5 mm anterior to the posterior border of the mandible to avoid injury to inferior alveolar neurovascular bundle. Patient is placed in maxillomandibular fixation (MMF) using a prefabricated occlusal splint to assure accuracy of the mandibular position. follow up clinical and radiographic evaluation will be performed at the first week postoperative then the patients will recalled for radiograghic evaluation at 2weeks and 2 months .finall follow up visit will be at 6 months postoperative

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Mandibular Prognathism
    Keywords
    Mandibular Prognanthism,customized plate

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    A Randomized Controlled Trial A Trial will be carried out in Hospital of Oral and Maxillofacial surgery departement- faculty of Dentistry , Cairo University Equal randomization : participant with equal probabilities for intervention Parallel group study : Each group of patients recieves a single treatment simultaneously
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    24 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Customized plate fixation
    Arm Type
    Experimental
    Arm Description
    Customized Plate fixation of Vertical Ramus Osteotomy after Mandibular Setback - intervention: All cases will undergo one surgery under general anesthesia. Incision was made medial to external oblique ridge from the asendindg ramus to second molar region The intraoral vertical osteotomy is accomplished by using an oscillating saw to make the cut from the sigmoid notch through the inferior border of the mandible. 3D virtual planning and 3D mandible model represented fom CBCT in MIMICS The customized fixation plate is positioned to fix the proximal and distal segment together
    Arm Title
    maxillomandibular fixation
    Arm Type
    Active Comparator
    Arm Description
    Mandibular Setback by Vertical Ramus Ostotmy fixed with Maxillomandibular fixation - intervention: All cases will undergo one surgery under general anesthesia incision was made medial to external oblique ridge from the asendindg ramus to second molar region . The intraoral vertical osteotomy is accomplished by using an oscillating saw to make the cut from the sigmoid notch through the inferior border of the mandible. Patient is placed in maxillomandibular fixation (MMF) using a prefabricated occlusal splint
    Intervention Type
    Procedure
    Intervention Name(s)
    customized fixation plate
    Other Intervention Name(s)
    patient specific osteosynthesis
    Intervention Description
    All cases will undergo one surgery under general anesthesia. Incision was made medial to external oblique ridge from the asendindg ramus to second molar region Amucoperiosteal flap was reflected to expose the lateral mandibular ramus to the posterior border and the sigmoid notch The intraoral vertical osteotomy is accomplished by using an oscillating saw to make the cut from the sigmoid notch through the inferior border of the mandible. 3D virtual planning and 3D mandible model represented fom CBCT in MIMICS The customized fixation plate is positioned to fix the proximal and distal segment together after setback
    Intervention Type
    Procedure
    Intervention Name(s)
    maxillomandibular fixation
    Other Intervention Name(s)
    intermaxillary fixation
    Intervention Description
    All cases will undergo one surgery under general anesthesia. incision was made medial to external oblique ridge from the asendindg ramus to second molar region . The intraoral vertical osteotomy is accomplished by using an oscillating saw to make the cut from the sigmoid notch through the inferior border of the mandible. Patient is placed in maxillomandibular fixation (MMF) using a prefabricated occlusal splint to assure accuracy of the mandibular position.
    Primary Outcome Measure Information:
    Title
    Patient Satisfaction
    Description
    Patient were asked to fill out a questionnaire in order to investigate their satisfaction degree after surgery ,according to an adapted (10 cm) visual analogue scale (VAS) from 0 to +10 0 is the least satisfied 10 is the most satisfied
    Time Frame
    immediately postoperative
    Secondary Outcome Measure Information:
    Title
    stability of Mandible
    Description
    assessed by determining the differences between measurements of three mandibular reference points (B-point, menton, and pogonion) in relation to SNy ,SNx axis obtained at six different time points
    Time Frame
    pre- operative , 2 weeks postoperative , 2 months postoperative , 6 months postoperative

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Months
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: All subjects were required: Patients with mandibular prognanthism indicated for mandibular setback. All ages >18 years Patients should be free from any systemic disease that may affect normal healing of bone, and predictable outcome. Patients with good general condition allowing surgical procedure under general anesthesia. Patients with physical and psychological tolerance Exclusion Criteria: History of mandibular trauma Previous orthognathic surgery Degenerative disease of temporomandibular joint Craniofacial syndrome such as cleft lip or palate Follow up period will be less than 6 months

    12. IPD Sharing Statement

    Learn more about this trial

    Patient Satisfaction Vertical Ramus Osteotomy Patient Specificosteosynthesis Fixation Versus MMFmandibular Prognanthism

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