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Clinical Study of INFUSE® Bone Graft Compared to Autogenous Bone Graft for Vertical Ridge Augmentation

Primary Purpose

Alveolar Bone Loss in Mandible, Edentulous Alveolar Ridge In Mandible

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
INFUSE® Bone Graft
Autogenous bone graft from tibia or iliac crest
Sponsored by
Medtronic Spinal and Biologics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alveolar Bone Loss in Mandible focused on measuring alveolar ridge augmentation, edentulous ridge, alveolar ridge defect, posterior mandible defect, bone morphogenic protein, osseointegration

Eligibility Criteria

21 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Has been edentulous for at least 2 months with an alveolar ridge defect affecting 2-4 teeth in the posterior mandible, posterior to the canine.
  2. Has an alveolar ridge defect with a minimum starting height of 5 mm above the superior cortex of the inferior alveolar canal in the posterior mandible.
  3. Is a candidate for dental implants (2-4 teeth) in the affected posterior mandibular alveolar ridge area.
  4. Has a prosthodontic treatment plan in place.
  5. Has no known condition that would interfere with collecting autogenous bone at either the tibia or the iliac crest for a bone grafting procedure.
  6. Is 21-75 years of age (inclusive).
  7. If female of childbearing potential, has a negative urine pregnancy test, is not lactating, and agrees not to become pregnant for at least 12 months after surgery.
  8. Is able to comply with all study-related procedures, including exercising good oral hygiene.
  9. Is able to provide written informed consent.

Exclusion Criteria:

  1. Has bilateral alveolar ridge defects requiring simultaneous augmentation or a second augmentation planned during the course of the study.
  2. Has an active infection at the planned augmentation site.
  3. Has active periodontal disease of Grade III or higher.
  4. Has had a dental extraction procedure at the planned augmentation site within the 2 months prior to Day 0.
  5. Has had a soft tissue graft at the planned augmentation site within less than 2 weeks of Screening.
  6. Is expected to require any additional bone graft material (e.g., allograft and xenograft) at the planned augmentation site in addition to the investigative treatment or autogenous bone, as determined by the investigator prior to surgery.
  7. Has a history of a failed alveolar ridge augmentation procedure.
  8. Has a pathology finding that would either compromise a bone grafting procedure or interfere with obtaining quantitative measurements from postoperative CT scans.
  9. Is an insulin-dependent diabetic.
  10. Has an overt or active systemic infection, such as human immunodeficiency virus (HIV), bacteremia, or hepatitis C virus (HCV).
  11. Has a planned augmentation site in the area of a resected or extant tumor.
  12. Has presence of an active malignancy or prior history of malignancy (except for basal cell carcinoma of the skin).
  13. Is actively using any nicotine-containing products such as, but not limited to, smoking and chewing tobacco, nicotine patch, nicotine gum, etc. within 2 weeks prior to Screening.
  14. Is alcohol or drug dependent, as determined by the investigator.
  15. Is taking medications or having treatment known to have an effect on bone metabolism, such as, but not limited to:

    • calcitonin within the past 6 months;
    • fluorides for 30 days or more within the past 12 months;
    • cumulative use of oral bisphosphonates for less than 5 years within the past 6 months;
    • cumulative use of oral bisphosphonates for 5 years or more;
    • any previous use of intravenous bisphosphonates;
    • chronic tetracycline (e.g., ongoing within the past month) or tetracycline analogs within the past 12 months;
    • estrogen replacement therapy within the past 2 months; or
    • methotrexate within the past 12 months.
  16. Has a disease that affects bone metabolism, such as:

    • congenital connective tissue disease (e.g., Ehlers-Danlos syndrome, osteogenesis imperfecta);
    • hyperthyroidism; or
    • hyperparathyroidism.
  17. Has a history of autoimmune disease (e.g., systemic lupus erythematosus, dermatomyositis, rheumatoid arthritis, etc.).
  18. Has any previous exposure to any recombinant BMPs of either human or animal extraction.
  19. Has a known history of prior exposure to silicone or injectable collagen implants.
  20. Has a known hypersensitivity or allergy to collagen or protein pharmaceuticals (e.g., monoclonal antibodies or gamma globulins).
  21. Has a known hypersensitivity or allergy to titanium.
  22. Has a history of allergy to bovine collagen products.
  23. Has chronic or acute renal failure
  24. Has chronic or acute liver failure.
  25. Has received treatment with an investigational therapy (drug, device, and/or biologic) within 30 days prior to bone graft implantation surgery or such treatment is planned during the 12-month period following the study surgery.
  26. Has any condition that in the judgment of the investigator would place the subject at undue risk or interfere with the results of the study.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    INFUSE® Bone Graft

    Autogenous bone graft

    Arm Description

    Outcomes

    Primary Outcome Measures

    Osseous volumetric fill underneath the titanium mesh of edentulous sites in the posterior mandible.

    Secondary Outcome Measures

    Pain level at the surgical site, as well as at the donor site (if applicable).
    Numerical rating scales used to evaluate pain intensity and frequency.
    Ability to place dental implants
    Histological evaluation (percent vital bone)
    Surgical failure rate
    Adverse Events

    Full Information

    First Posted
    March 2, 2011
    Last Updated
    September 11, 2018
    Sponsor
    Medtronic Spinal and Biologics
    Collaborators
    Averion International Corporation, Baim Institute for Clinical Research
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01308996
    Brief Title
    Clinical Study of INFUSE® Bone Graft Compared to Autogenous Bone Graft for Vertical Ridge Augmentation
    Official Title
    A Prospective, Open Label, Randomized, Multicenter, Controlled Clinical Study of INFUSE® Bone Graft Used as an Alternative to Autogenous Bone Graft for Vertical Alveolar Ridge Augmentation
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2012
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    April 2012 (undefined)
    Primary Completion Date
    July 2017 (Anticipated)
    Study Completion Date
    September 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Medtronic Spinal and Biologics
    Collaborators
    Averion International Corporation, Baim Institute for Clinical Research

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purpose of this study is to evaluate the INFUSE® Bone Graft as an alternative to autograft for bone formation in the back of the mandible (lower jaw) prior to placing dental implants.
    Detailed Description
    The purpose of this study is to evaluate INFUSE® Bone Graft as an alternative to autograft for alveolar ridge bone formation in the posterior mandible prior to dental implants. A subject must have a defect behind the canine of 2-4 teeth for at least 2 months and be a candidate for dental implants.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Alveolar Bone Loss in Mandible, Edentulous Alveolar Ridge In Mandible
    Keywords
    alveolar ridge augmentation, edentulous ridge, alveolar ridge defect, posterior mandible defect, bone morphogenic protein, osseointegration

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    INFUSE® Bone Graft
    Arm Type
    Experimental
    Arm Title
    Autogenous bone graft
    Arm Type
    Active Comparator
    Intervention Type
    Device
    Intervention Name(s)
    INFUSE® Bone Graft
    Intervention Description
    Implantation of INFUSE® Bone Graft [recombinant human Bone Morphogenetic Protein-2 (rhBMP-2)] and absorbable collagen sponge (ACS) carrier at 1.50 mg/cc with space maintenance device
    Intervention Type
    Procedure
    Intervention Name(s)
    Autogenous bone graft from tibia or iliac crest
    Intervention Description
    Implantation of autogenous bone graft from iliac crest or tibia with titanium mesh space maintenance device
    Primary Outcome Measure Information:
    Title
    Osseous volumetric fill underneath the titanium mesh of edentulous sites in the posterior mandible.
    Time Frame
    210 days
    Secondary Outcome Measure Information:
    Title
    Pain level at the surgical site, as well as at the donor site (if applicable).
    Description
    Numerical rating scales used to evaluate pain intensity and frequency.
    Time Frame
    210 days
    Title
    Ability to place dental implants
    Time Frame
    210 days
    Title
    Histological evaluation (percent vital bone)
    Time Frame
    210 days
    Title
    Surgical failure rate
    Time Frame
    210 days
    Title
    Adverse Events
    Time Frame
    210 Days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    21 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Has been edentulous for at least 2 months with an alveolar ridge defect affecting 2-4 teeth in the posterior mandible, posterior to the canine. Has an alveolar ridge defect with a minimum starting height of 5 mm above the superior cortex of the inferior alveolar canal in the posterior mandible. Is a candidate for dental implants (2-4 teeth) in the affected posterior mandibular alveolar ridge area. Has a prosthodontic treatment plan in place. Has no known condition that would interfere with collecting autogenous bone at either the tibia or the iliac crest for a bone grafting procedure. Is 21-75 years of age (inclusive). If female of childbearing potential, has a negative urine pregnancy test, is not lactating, and agrees not to become pregnant for at least 12 months after surgery. Is able to comply with all study-related procedures, including exercising good oral hygiene. Is able to provide written informed consent. Exclusion Criteria: Has bilateral alveolar ridge defects requiring simultaneous augmentation or a second augmentation planned during the course of the study. Has an active infection at the planned augmentation site. Has active periodontal disease of Grade III or higher. Has had a dental extraction procedure at the planned augmentation site within the 2 months prior to Day 0. Has had a soft tissue graft at the planned augmentation site within less than 2 weeks of Screening. Is expected to require any additional bone graft material (e.g., allograft and xenograft) at the planned augmentation site in addition to the investigative treatment or autogenous bone, as determined by the investigator prior to surgery. Has a history of a failed alveolar ridge augmentation procedure. Has a pathology finding that would either compromise a bone grafting procedure or interfere with obtaining quantitative measurements from postoperative CT scans. Is an insulin-dependent diabetic. Has an overt or active systemic infection, such as human immunodeficiency virus (HIV), bacteremia, or hepatitis C virus (HCV). Has a planned augmentation site in the area of a resected or extant tumor. Has presence of an active malignancy or prior history of malignancy (except for basal cell carcinoma of the skin). Is actively using any nicotine-containing products such as, but not limited to, smoking and chewing tobacco, nicotine patch, nicotine gum, etc. within 2 weeks prior to Screening. Is alcohol or drug dependent, as determined by the investigator. Is taking medications or having treatment known to have an effect on bone metabolism, such as, but not limited to: calcitonin within the past 6 months; fluorides for 30 days or more within the past 12 months; cumulative use of oral bisphosphonates for less than 5 years within the past 6 months; cumulative use of oral bisphosphonates for 5 years or more; any previous use of intravenous bisphosphonates; chronic tetracycline (e.g., ongoing within the past month) or tetracycline analogs within the past 12 months; estrogen replacement therapy within the past 2 months; or methotrexate within the past 12 months. Has a disease that affects bone metabolism, such as: congenital connective tissue disease (e.g., Ehlers-Danlos syndrome, osteogenesis imperfecta); hyperthyroidism; or hyperparathyroidism. Has a history of autoimmune disease (e.g., systemic lupus erythematosus, dermatomyositis, rheumatoid arthritis, etc.). Has any previous exposure to any recombinant BMPs of either human or animal extraction. Has a known history of prior exposure to silicone or injectable collagen implants. Has a known hypersensitivity or allergy to collagen or protein pharmaceuticals (e.g., monoclonal antibodies or gamma globulins). Has a known hypersensitivity or allergy to titanium. Has a history of allergy to bovine collagen products. Has chronic or acute renal failure Has chronic or acute liver failure. Has received treatment with an investigational therapy (drug, device, and/or biologic) within 30 days prior to bone graft implantation surgery or such treatment is planned during the 12-month period following the study surgery. Has any condition that in the judgment of the investigator would place the subject at undue risk or interfere with the results of the study.

    12. IPD Sharing Statement

    Learn more about this trial

    Clinical Study of INFUSE® Bone Graft Compared to Autogenous Bone Graft for Vertical Ridge Augmentation

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