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Withdrawn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
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
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.
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
NCT ID
NCT01308996
First Posted
March 2, 2011
Last Updated
September 11, 2018
Sponsor
Medtronic Spinal and Biologics
Collaborators
Averion International Corporation, Baim Institute for Clinical Research
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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