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Ridge Augmentation: Particulate v/s Block Graft

Primary Purpose

Alveolar Bone Loss

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Block allograft
Particulate allograft + autogenous bone chips
Sponsored by
University of Louisville
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alveolar Bone Loss

Eligibility Criteria

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

Inclusion Criteria:

  • At least a one tooth area with a ridge defect, treatment planned to receive a dental implant. The site must be bordered by at least one tooth.
  • Healthy person that is at least 18 years old.
  • Patient understands and signs an informed consent approved by the University of Louisville Human Studies Committee.

Exclusion Criteria:

  • Patients with debilitating systemic diseases, diseases that significantly affect the periodontium, or psychological problems that would interfere with treatment.
  • Previous head and neck radiation or chemotherapy within the previous 12 months.
  • Patients with known allergy to any of the materials that will be used in the study.
  • Smokers.
  • Patients on oral bisphosphonates > 3 years or any IV bisphosphonates.
  • Patients who are pregnant.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Particulate allograft + autogenous bone.

    Block allograft

    Arm Description

    In the test arm of the study the treatment will include a mix of MinerOss CorticoCancellous Particulate allograft + autogenous bone chips.

    The positive control treatment will include a block allograft plus Mineross corticocancellous particulate allograft.

    Outcomes

    Primary Outcome Measures

    Horizontal ridge width changes
    Site width (horizontal) changes by comparing the pre- to the 4 month post- augmentation dimensions of hard tissues.

    Secondary Outcome Measures

    Vertical ridge height changes
    Site height (vertical) changes by comparing the pre- to the 4 month post-augmentation dimensions of hard tissues.
    Histologic composition of the graft
    Histologic composition at 4 month post graft. (Histologic percent vital bone, nonvital bone and trabecular space.)

    Full Information

    First Posted
    June 19, 2015
    Last Updated
    December 31, 2017
    Sponsor
    University of Louisville
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02487784
    Brief Title
    Ridge Augmentation: Particulate v/s Block Graft
    Official Title
    Ridge Augmentation Comparing the Clinical and Histologic Healing of a Cancellous Block Allograft Versus Corticocancellous Particulate Allograft Mixed With Autogenous Bone Chips
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2015 (undefined)
    Primary Completion Date
    June 2016 (Actual)
    Study Completion Date
    June 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Louisville

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The primary aims of this study are to compare the clinical and histologic results of bone regeneration with a cancellous block allograft versus MinerOss Cortico cancellous particulate allograft mixed with autogenous bone chips after 4 months of healing. Titanium reinforced hd-PTFE (Cytoplast) membrane GBR will be used to cover the bone grafts. Specific Aim 1: To compare the baseline to 4 month change in clinical ridge width and height. Specific Aim 2: To compare the histologic percent of vital and nonvital bone and trabecular space at 4 months. The primary outcome variable is the change in horizontal ridge width. The secondary outcomes are the change in ridge height and the percent histologic composition of the augmented site.
    Detailed Description
    30 patients will be treated using the principles of guided bone regeneration and ridge augmentation. 15 test patients will receive a corticocancellous particulate allograft mixed with autogenous bone chips. The positive control group of 15 patients will receive a cancellous block allograft. Both the groups will receive a hd-PTFE (Cytoplast) barrier membrane. An allograft can be defined as bone that can be obtained from a different individual of the same species (human donor bone) whereas a autograft can be defined as bone that can be obtained from the same individual. Following flap reflection, vertical measurements will be done using a acrylic occlusal stent and horizontal measurements will be done using a specially designed caliper. Approximately 4 months post surgery, a trephine core will be taken from the grafted site immediately prior to the implant placement and submitted for histologic processing. The last step in the study will be to obtain a trephine core (2.7 X 6mm). After the core is harvested a dental implant will be placed. Implant placement should be considered a post study treatment procedure. There is no intent to investigate implant placement outcome. Step serial sections will be taken from each longitudinally sectioned core. The sections will be stained with hematoxylin and eosin. Ten slides per patient will be prepared with at least 4 sections per slide. For each patient 6 of 10 slides will be assessed. The mean percentages of vital and non vital bone and trabecular space will be determined for each patient by using an American Optical Microscope at 150X with a 10 X10 ocular grid. Histologic preparation will result in destruction of the trephine cores. Means and standard deviations will be calculated for all parameters. A paired t-test will be used to evaluate the statistical significance of the differences between initial and final data. An unpaired t-test will be used to evaluate statistical differences between the test and control groups.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    15 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Particulate allograft + autogenous bone.
    Arm Type
    Experimental
    Arm Description
    In the test arm of the study the treatment will include a mix of MinerOss CorticoCancellous Particulate allograft + autogenous bone chips.
    Arm Title
    Block allograft
    Arm Type
    Active Comparator
    Arm Description
    The positive control treatment will include a block allograft plus Mineross corticocancellous particulate allograft.
    Intervention Type
    Procedure
    Intervention Name(s)
    Block allograft
    Other Intervention Name(s)
    Cancellous block allograft
    Intervention Description
    A cancellous block allograft plus corticocancellous particulate allograft will be used as the positive control treatment.
    Intervention Type
    Procedure
    Intervention Name(s)
    Particulate allograft + autogenous bone chips
    Other Intervention Name(s)
    Particulate + ABC
    Intervention Description
    The test arm of this study will include a mix of particulate bone allograft and autogenous bone chips.
    Primary Outcome Measure Information:
    Title
    Horizontal ridge width changes
    Description
    Site width (horizontal) changes by comparing the pre- to the 4 month post- augmentation dimensions of hard tissues.
    Time Frame
    4 months
    Secondary Outcome Measure Information:
    Title
    Vertical ridge height changes
    Description
    Site height (vertical) changes by comparing the pre- to the 4 month post-augmentation dimensions of hard tissues.
    Time Frame
    4 months
    Title
    Histologic composition of the graft
    Description
    Histologic composition at 4 month post graft. (Histologic percent vital bone, nonvital bone and trabecular space.)
    Time Frame
    4 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: At least a one tooth area with a ridge defect, treatment planned to receive a dental implant. The site must be bordered by at least one tooth. Healthy person that is at least 18 years old. Patient understands and signs an informed consent approved by the University of Louisville Human Studies Committee. Exclusion Criteria: Patients with debilitating systemic diseases, diseases that significantly affect the periodontium, or psychological problems that would interfere with treatment. Previous head and neck radiation or chemotherapy within the previous 12 months. Patients with known allergy to any of the materials that will be used in the study. Smokers. Patients on oral bisphosphonates > 3 years or any IV bisphosphonates. Patients who are pregnant.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Henry Greenwell, DMD, MSD
    Organizational Affiliation
    Director of Graduate Periodontics, School of Dentistry, University of Louisville.
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Ridge Augmentation: Particulate v/s Block Graft

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