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The Efficiency of Computer Guided Ridge Splitting Using Piezosurgery in Horizontally Deficient Posterior Mandible

Primary Purpose

Edentulous Patients, Atrophic Posterior Mandible With Insufficient Width

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Computer Guided ridge splitting in posterior mandible
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Edentulous Patients

Eligibility Criteria

25 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with edentulous posterior area of the mandible insufficient width less than 5m, Both sexes.
  • No intraoral soft and hard tissue pathology
  • No systemic condition that contraindicate implant placement.

Exclusion Criteria:

  • Heavy smokers more than 20 cigarettes per day.
  • Patients with systemic disease that may affect normal healing.
  • Psychiatric problems.
  • Disorders to implant are related to history of radiation therapy to the head and neck neoplasia, or bone augmentation to implant site.
  • Immunodeficiency pathology, bruxism, stress situation (socially or professionally), emotional instability, and unrealistic aesthetic demands.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Computer Guided ridge splitting in posterior mandible

    Arm Description

    fabrication of a computer aided surgical guide and performing ridge splitting in posterior mandible using piezosurgery

    Outcomes

    Primary Outcome Measures

    Time of the procedure ,pain and edema
    the time of the procedure will be measured numerical using visual analogue scan

    Secondary Outcome Measures

    Full Information

    First Posted
    November 14, 2018
    Last Updated
    November 18, 2018
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03748615
    Brief Title
    The Efficiency of Computer Guided Ridge Splitting Using Piezosurgery in Horizontally Deficient Posterior Mandible
    Official Title
    The Efficiency of Computer Guided Ridge Splitting Using Piezosurgery in Horizontally Deficient Posterior Mandible
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    November 20, 2018 (Anticipated)
    Primary Completion Date
    September 20, 2019 (Anticipated)
    Study Completion Date
    November 20, 2019 (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 use of implants has significantly increased prosthetic options for edentulous patient. However, implant placement in the Posterior mandibular region is often hampered significantly by insufficient atrophic width limitations
    Detailed Description
    Ridge splitting technique causes lateral ridge expansion which creates new implant bed by longitudinal osteotomy, positioning buccal cortex laterally. The buccal cortex is positioned laterally to create space between buccal and lingual cortical plates, which is filled by an endosseous implant with or without any graft material limitations. Ridge split technique is a very predictable procedure that can achieve substantial gains in horizontal ridge width of the edentulous posterior mandible without associated morbidity. This technique allows the clinician to augment the site and do the implant insertion in a single stage surgery, shortening the healing period drastically. In the conventional ridge splitting technique, a complete flap is raised to allow adequate visibility of the bone defect which can result in disturbance of vascular supply and increase bone resorption rates. In this case report, a new innovative computer guided closed alveolar ridge splitting flapless technique has been advocated to avoid this disruption. As Guided implant placement showed a statistically superior accuracy when they are compared with freehand placement after guided osteotomy Computer guided ridge splitting may have a superior accuracy than the freehand ridge splitting and may reduce the time of surgery, healing period and post-operative pain.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Edentulous Patients, Atrophic Posterior Mandible With Insufficient Width

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    10 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Computer Guided ridge splitting in posterior mandible
    Arm Type
    Experimental
    Arm Description
    fabrication of a computer aided surgical guide and performing ridge splitting in posterior mandible using piezosurgery
    Intervention Type
    Device
    Intervention Name(s)
    Computer Guided ridge splitting in posterior mandible
    Intervention Description
    The computer guided ridge splitting for patients with atrophic posterior mandible and with residual bone width at least 3 to 5mm of residual ridge. The selected patients will be informed of the nature of the research work and informed consent will be signed. Radiographic examination included preoperative digital panoramic radiograph with 1:1 magnification for each patient as a primary survey to obtain an approximation of the available bone height and detect the presence of remaining roots and localized pathosis. Computer surgical guides are fabricated for partially edentulous patients using teeth and tissue as support for the guide. The same surgeon performed all surgeries. All surgical procedures were performed under strict aseptic conditions, all patients received nerve block local anesthesia (Articaine 4% 1:100 000 epinephrine). A crestal incision is made using No. 15 blade extending over the posterior mandible using computer guided surgical stent. no flap elevation .
    Primary Outcome Measure Information:
    Title
    Time of the procedure ,pain and edema
    Description
    the time of the procedure will be measured numerical using visual analogue scan
    Time Frame
    4 month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    25 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients with edentulous posterior area of the mandible insufficient width less than 5m, Both sexes. No intraoral soft and hard tissue pathology No systemic condition that contraindicate implant placement. Exclusion Criteria: Heavy smokers more than 20 cigarettes per day. Patients with systemic disease that may affect normal healing. Psychiatric problems. Disorders to implant are related to history of radiation therapy to the head and neck neoplasia, or bone augmentation to implant site. Immunodeficiency pathology, bruxism, stress situation (socially or professionally), emotional instability, and unrealistic aesthetic demands.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    wallaa farahat mohamed, bds
    Phone
    01069543488
    Email
    loulu_90_ooo@hotmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    mohammed khashaba, phd
    Phone
    01227754765
    Email
    mohammedkhashaba@hotmail.com

    12. IPD Sharing Statement

    Learn more about this trial

    The Efficiency of Computer Guided Ridge Splitting Using Piezosurgery in Horizontally Deficient Posterior Mandible

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