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Evaluation of Alveolar Augmentation Using Tunneling Surgical Technique

Primary Purpose

Bone Atrophy

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
tunneling surgical technique
Sponsored by
Hussien Amer Elkady
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bone Atrophy

Eligibility Criteria

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

Inclusion Criteria:

  • Patients' age range from 18-60 years.
  • Patients with horizontal bone defect in anterior maxillary area.
  • Patients should be free from any systemic disease that may affect normal healing of bone and predictable outcome.

Exclusion Criteria:

• Patients with systemic diseases as history of radiation therapy or chemotherapy, hematological disorders and autoimmune diseases (may affect normal healing).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    tunneling surgical technique

    Arm Description

    Outcomes

    Primary Outcome Measures

    bone formation
    bone formation assessed by cone beam ct

    Secondary Outcome Measures

    Full Information

    First Posted
    March 29, 2018
    Last Updated
    April 7, 2018
    Sponsor
    Hussien Amer Elkady
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03498573
    Brief Title
    Evaluation of Alveolar Augmentation Using Tunneling Surgical Technique
    Official Title
    Evaluation of Minimally Invasive Alveolar Augmentation Procedure of Anterior Maxillary Ridge Using Tunneling Surgical Technique
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    May 1, 2018 (Anticipated)
    Primary Completion Date
    July 2018 (Anticipated)
    Study Completion Date
    April 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Hussien Amer Elkady

    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
    patients suffering from anterior maxillary horizontal bone defect the alveolar ridge will be augmented by minimally invasive tunneling technique utilizing MPM as bone graft and patients followed up for 14 weeks .

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Bone Atrophy

    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
    tunneling surgical technique
    Arm Type
    Experimental
    Intervention Type
    Other
    Intervention Name(s)
    tunneling surgical technique
    Other Intervention Name(s)
    mpm
    Intervention Description
    sticky bone prepared by centrifuge patient blood and mixing with xinograft
    Primary Outcome Measure Information:
    Title
    bone formation
    Description
    bone formation assessed by cone beam ct
    Time Frame
    14 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients' age range from 18-60 years. Patients with horizontal bone defect in anterior maxillary area. Patients should be free from any systemic disease that may affect normal healing of bone and predictable outcome. Exclusion Criteria: • Patients with systemic diseases as history of radiation therapy or chemotherapy, hematological disorders and autoimmune diseases (may affect normal healing).
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    hussien amer elkady, B.D.S
    Phone
    01141178095
    Email
    elkady_003@yahoo.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    tarek elghareeb

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    19639058
    Citation
    Nevins ML, Camelo M, Nevins M, Schupbach P, Friedland B, Camelo JM, Kim DM. Minimally invasive alveolar ridge augmentation procedure (tunneling technique) using rhPDGF-BB in combination with three matrices: a case series. Int J Periodontics Restorative Dent. 2009 Aug;29(4):371-83.
    Results Reference
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    Evaluation of Alveolar Augmentation Using Tunneling Surgical Technique

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