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Guided Bone Regeneration in Atrophic Anterior Maxillary Ridges

Primary Purpose

Bone Resorption Disorder

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
GBR by xenograft and autogenous bone
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Bone Resorption Disorder focused on measuring GBR, autogenous bone, xenograft

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients with atrophied anterior maxillary ridge area.
  • Age: 18 years and older.
  • Both sexes.
  • No intraoral soft and hard tissue pathology.
  • No systemic condition that contraindicate bone augmentation

Exclusion Criteria:

  • • Heavy smokers more than 20 cigarettes per day.(32)

    • Patients with systemic disease that may affect normal healing.
    • Psychiatric problems.
    • Disorders to bone augmentation are related to history of radiation therapy to the head and neck neoplasia.
    • Pregnant or nursing women.
    • Patients with uncontrolled diabetes mellitus, rheumatoid arthritis or osteoporosis.
    • Patient with previous history of radiotherapy.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Active Comparator

    Arm Label

    GBR by xenograft

    GBR by xenograft ,autogenous bone

    Arm Description

    Patients of both groups will be subjected to CBCT (diagnostic for upper arch). Intra operative procedures (for both groups) followed by CBCT will be taken for every patient. Local anesthesia will be given to the patient. Scrubbing and draping of the patient will be carried out in a standard fashion for intra oral procedures. Flap will be done. In the study group: bone decortication will be done using surgical round bur, anorganic bovine bone derived mineral will be packed then covered at the defected area by a native collagen membrane which will be stabilized by tacks. • The site will then be copiously irrigated with saline in preparation for closure. The flap will then be closed using interrupted 4/0 resorbable sutures.

    Intervention In the control group:first crestal incision then two vertical incisions by blade 15c,full thickness flap reflection, bone decortication will be done using surgical round bur, autogenous bone will be harvested by trephine bur ,mixed 1:1 with anorganic bovine bone derived mineral and packed at the defected area(atrophic maxilla) then covered by a native collagen membrane which will be stabilized by tacks.Then The flap will then be closed using interrupted 4/0 resorbable sutures.

    Outcomes

    Primary Outcome Measures

    Height and width of bone gained
    Height and width of bone gained in mm by CBCT

    Secondary Outcome Measures

    Bone area percentage
    Bone area percentage % by Histo-morphometric analysis

    Full Information

    First Posted
    November 3, 2018
    Last Updated
    August 28, 2019
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03731416
    Brief Title
    Guided Bone Regeneration in Atrophic Anterior Maxillary Ridges
    Official Title
    Ridge Augmentation in Atrophic Anterior Maxillary Ridges With Native Collagen Membrane and Anorganic Bovine Bone Derived Mineral With and Without Particulated Autogenous Bone Chips
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 1, 2019 (Anticipated)
    Primary Completion Date
    November 1, 2019 (Anticipated)
    Study Completion Date
    November 12, 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

    5. Study Description

    Brief Summary
    This study is aiming to evaluate clinically, radiographically ,and histologically GBR using collagen membrane in combination with a mixture of ABBM and autogenous particulated bone compared to collagen membrane with ABBM in atrophied anterior maxilla.
    Detailed Description
    Guided bone regeneration (GBR) has been proposed as a possible alternative for patients with severe horizontal bone atrophy, to overcome the drawback of bone blocks techniques.6,8 To protect and prevent the invasion of the clot by nonosteogenic cells, maintaining an adequate biological space for the regeneration of bone tissue, the use of resorbable membranes, in combination with autologous or heterologous particulate bone have been proposed. Expanded polytetrafluoroethylene (e-PTFE) membranes are the most used non-resorbable membranes with the longest published follow-up, considering them the gold standard in the reconstructions of major horizontal bone defects. However, a second surgery is needed to remove them and they may get exposed in the oral cavity and contaminate with possible infection and graft loss. Conversely, the resorbable membranes most advantages are an ability to merge with the host tissues, as well as a rapid resorption in case of exposure, thereby reducing the risk of bacterial contamination. Resorbable membranes in combination with particulated anorganic bovine bone (ABB) can be used for the augmentation of horizontally deficient ridges. Particulated autogenous bone can be mixed with bone substitutes to add more osteogenic factors.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Bone Resorption Disorder
    Keywords
    GBR, autogenous bone, xenograft

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    The patients will be randomly divided into 2 equal groups
    Masking
    Investigator
    Masking Description
    Each patient will be given a code by the researcher and the observers will be blind to which group this case belong.
    Allocation
    Randomized
    Enrollment
    10 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    GBR by xenograft
    Arm Type
    Placebo Comparator
    Arm Description
    Patients of both groups will be subjected to CBCT (diagnostic for upper arch). Intra operative procedures (for both groups) followed by CBCT will be taken for every patient. Local anesthesia will be given to the patient. Scrubbing and draping of the patient will be carried out in a standard fashion for intra oral procedures. Flap will be done. In the study group: bone decortication will be done using surgical round bur, anorganic bovine bone derived mineral will be packed then covered at the defected area by a native collagen membrane which will be stabilized by tacks. • The site will then be copiously irrigated with saline in preparation for closure. The flap will then be closed using interrupted 4/0 resorbable sutures.
    Arm Title
    GBR by xenograft ,autogenous bone
    Arm Type
    Active Comparator
    Arm Description
    Intervention In the control group:first crestal incision then two vertical incisions by blade 15c,full thickness flap reflection, bone decortication will be done using surgical round bur, autogenous bone will be harvested by trephine bur ,mixed 1:1 with anorganic bovine bone derived mineral and packed at the defected area(atrophic maxilla) then covered by a native collagen membrane which will be stabilized by tacks.Then The flap will then be closed using interrupted 4/0 resorbable sutures.
    Intervention Type
    Procedure
    Intervention Name(s)
    GBR by xenograft and autogenous bone
    Intervention Description
    Ridge augmentation by native collagen membrane and mix of anorganic bovine bone derived mineral with particulated autogenous bone chips (ratio 1:1).
    Primary Outcome Measure Information:
    Title
    Height and width of bone gained
    Description
    Height and width of bone gained in mm by CBCT
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Bone area percentage
    Description
    Bone area percentage % by Histo-morphometric analysis
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patients with atrophied anterior maxillary ridge area. Age: 18 years and older. Both sexes. No intraoral soft and hard tissue pathology. No systemic condition that contraindicate bone augmentation Exclusion Criteria: • Heavy smokers more than 20 cigarettes per day.(32) Patients with systemic disease that may affect normal healing. Psychiatric problems. Disorders to bone augmentation are related to history of radiation therapy to the head and neck neoplasia. Pregnant or nursing women. Patients with uncontrolled diabetes mellitus, rheumatoid arthritis or osteoporosis. Patient with previous history of radiotherapy.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Hossam Elbaha, Master
    Phone
    +201277750002
    Email
    hossam_elbaha@yahoo.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    hossam Elbaha
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    hossam Elbaha
    Organizational Affiliation
    Cairo University
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    27283920
    Citation
    Meloni SM, Jovanovic SA, Urban I, Canullo L, Pisano M, Tallarico M. Horizontal Ridge Augmentation using GBR with a Native Collagen Membrane and 1:1 Ratio of Particulated Xenograft and Autologous Bone: A 1-Year Prospective Clinical Study. Clin Implant Dent Relat Res. 2017 Feb;19(1):38-45. doi: 10.1111/cid.12429. Epub 2016 Jun 9.
    Results Reference
    result
    Available IPD and Supporting Information:
    Available IPD/Information Type
    Study Protocol
    Available IPD/Information URL
    https://www.ncbi.nlm.nih.gov/pubmed/27283920

    Learn more about this trial

    Guided Bone Regeneration in Atrophic Anterior Maxillary Ridges

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