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Vertical and Horizontal Alveolar Ridge Augmentation Using Autogenous Onlay Blocks Combined With Guided Bone Regeneration Using Native Collagen Membrane in Atrophic Anterior Maxilla.

Primary Purpose

Anterior Maxilla With Deficient Ridge Height and/or Width

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
autogenous ring blockls with GBR covered by collagen membrane
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anterior Maxilla With Deficient Ridge Height and/or Width

Eligibility Criteria

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

Inclusion Criteria:

  • Patients with partially edentulous in the anterior area of the maxilla, with a residual ridge that allowed insertion of ≤11.5 mm length implants.
  • Both sexes.
  • No intraoral soft and hard tissue pathology
  • No systemic condition that contraindicate implant placement.

Exclusion Criteria:

  • Pathology.
  • 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

    autogenous ring blockls with GBR covered by collagen membrane

    Arm Description

    Vertical and horizontal ridge augmentation using autogenous onlay ring blocks combined with simultaneous guided bone regeneration using native collagen membrane in atrophic anterior maxilla.

    Outcomes

    Primary Outcome Measures

    Bone gained vertically
    Amount of bone gained vertically will be measured using CBCT

    Secondary Outcome Measures

    Full Information

    First Posted
    March 28, 2019
    Last Updated
    March 28, 2019
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03895060
    Brief Title
    Vertical and Horizontal Alveolar Ridge Augmentation Using Autogenous Onlay Blocks Combined With Guided Bone Regeneration Using Native Collagen Membrane in Atrophic Anterior Maxilla.
    Official Title
    Vertical and Horizontal Alveolar Ridge Augmentation Using Autogenous Onlay Ring Blocks Combined With Simultaneous Guided Bone Regeneration Using Native Collagen Membrane in Atrophic Anterior Maxilla.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 1, 2019 (Anticipated)
    Primary Completion Date
    March 1, 2020 (Anticipated)
    Study Completion Date
    March 30, 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
    Many different techniques exist for effective vertical bone augmentation, such as the use of particulate bone grafts and bone graft substitutes, barrier membranes for guided bone regeneration (GBR), autogenous and allogenic block grafts, and the application of distraction osteogenesis. Harvesting of autogenous block grafts is associated with greater morbidity compared with the less invasive procedure of using autogenous particles harvested through bone scrapers. On the other hand, particulate grafts always require a space-maintaining barrier, or their physical properties would not allow three-dimensional bone regeneration as those of block grafts do.
    Detailed Description
    An autogenous ring block is harvested from the chin area by trephine bur and the autogenous bone chips will be collected with a bone scraper, then a specially manufactured machine titanium tenting screw is used to fasten the ring block to the alveolar ridge. Two or three ring blocks is screwed according to the defect. Then resorbable collagen membrane is fixed to the alveolar ridge instead of the titanium-reinforced e-PTFE and equally autogenous and xenograft bone particles is packed around the screw to fill the defect area completely. Extreme care is taken to avoid autogenous particles drifting distally toward the area of the block. The barrier membrane was then closed over the block and particulate graft and fixed by bone tacks. Then periosteal releasing incision is done to allow tension free adaption of the mucoperisteal flap.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Anterior Maxilla With Deficient Ridge Height and/or 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
    autogenous ring blockls with GBR covered by collagen membrane
    Arm Type
    Experimental
    Arm Description
    Vertical and horizontal ridge augmentation using autogenous onlay ring blocks combined with simultaneous guided bone regeneration using native collagen membrane in atrophic anterior maxilla.
    Intervention Type
    Device
    Intervention Name(s)
    autogenous ring blockls with GBR covered by collagen membrane
    Intervention Description
    A crestal incision is made using No. 15 blade extending over the anterior maxilla, an anterior vertical releasing incision is made and a full mucoperiosteum flaps elevated to provide access to the alveolar ridge and the lateral aspect of the maxilla Autogenous onlay ring blocks is taken by a trephine bur from the chin area and then fixed by screws to the deficient maxillary alveolar height. Equally autogenous and xenograft bone particles is packed around the screw to fill the defect area completely. The collagen membrane is fixed to the alveolar ridge by bone tacks and the mixture of autogenous and xenograft bone is then packed. The flap will then be closed using interrupted 4/0 resorbable sutures.
    Primary Outcome Measure Information:
    Title
    Bone gained vertically
    Description
    Amount of bone gained vertically will be measured using CBCT
    Time Frame
    6 months

    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 partially edentulous in the anterior area of the maxilla, with a residual ridge that allowed insertion of ≤11.5 mm length implants. Both sexes. No intraoral soft and hard tissue pathology No systemic condition that contraindicate implant placement. Exclusion Criteria: Pathology. 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
    Reham Dewedar, BDS
    Phone
    +201018418031
    Email
    rehammoemen20@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mohamed Atef, PhD
    Phone
    +201009612708
    Email
    zokasur@gmail.com

    12. IPD Sharing Statement

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