Localized Alveolar Ridge Augmentation With Space Maintenance Devices (Ridge Mesh)

This study has been terminated.
Sponsor:
Collaborator:
Averion International Corporation
Information provided by (Responsible Party):
Medtronic Spinal and Biologics
ClinicalTrials.gov Identifier:
NCT00991432
First received: October 6, 2009
Last updated: February 15, 2012
Last verified: September 2011
  Purpose

The purpose of this research study is to determine whether this study treatment can improve the bone structure of the upper front part of the jaw in patients who are scheduled for surgery to have a dental implant(s) placed into the upper front part of their mouths and need to have more bone in their jaws to support the implant, so that a dental implant can later be inserted.


Condition Intervention
Alveolar Bone Loss
Device: INFUSE® Bone Graft

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Open Label, Non-randomized, Single-arm, Multi-center Study to Assess Localized Alveolar Ridge Augmentation Utilizing INFUSE® Bone Graft Concurrent With Space Maintenance Devices for Soft Tissue Management

Resource links provided by NLM:


Further study details as provided by Medtronic Spinal and Biologics:

Primary Outcome Measures:
  • Alveolar ridge bone formation sufficient to place endosseous implants [ Time Frame: approximately 6 months post-surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evidence of successful INFUSE® Bone Graft placement, an increase in the alveolar ridge width and the safety of INFUSE® as assessed by CT scans. [ Time Frame: approximately 6 months post-surgery ] [ Designated as safety issue: Yes ]

Enrollment: 10
Study Start Date: October 2009
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
INFUSE® Bone Graft
all study participants will receive INFUSE® Bone Graft
Device: INFUSE® Bone Graft
Patients will be treated with the commercially available INFUSE® Bone Graft material applied to an ACS concurrent with space maintenance devices for soft tissue management on Day 0 (Surgery). A follow-up visit will take place 2 weeks after implant of the INFUSE® Bone Graft material, or as regularly scheduled as per the standard of care (SOC) for the facility. Patients will return to the facility for final End of Study (EOS) assessments approximately 6 months after surgery. Between the follow-up visit and the EOS visit, patients will be seen as per the SOC schedule for the facility.

Detailed Description:

The INFUSE® Bone Graft is a device approved by the FDA to be used instead of using your own bone (from another site on your body) to replace missing bone in your jaw. INFUSE® Bone Graft is commercially available and is made up of 2 parts - recombinant human Bone Morphogenetic Protein-2 (rhBMP 2) placed on an absorbable collagen sponge (ACS). The rhBMP-2 is a genetically altered protein which recruits bone-forming cells to the surgical area and changes local cells to bone. ACS is made from Type I collagen from bovine (cattle) tendon. It helps to hold the rhBMP-2 in place and acts as a support for the growing bone. The sponge itself will reabsorb in time as the new bone forms.

The purpose of this research study is to determine whether this study treatment can improve the bone structure of the upper front part of the jaw so that a dental implant can later be inserted. This post-market study has been designed to further evaluate the effectiveness and safety of INFUSE® Bone Graft, along with space holding devices, in a 2-part procedure. Your dental implants will be placed at approximately 6 months after the INFUSE® Bone Graft implant.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients needing bone augmentation of the alveolar ridge

Criteria

Inclusion Criteria:

  1. Able to provide written informed consent
  2. ≥ 18 years
  3. Scheduled for dental implant into anterior maxillary alveolar ridge
  4. Negative urine pregnancy test for patients of child bearing potential and agreement not to become pregnant for at least 12 months after surgery
  5. Able to comply with all study-related procedures, including exercising good oral hygiene
  6. A prosthodontic treatment plan has been drafted.

Exclusion Criteria:

  1. Known hypersensitivity to rhBMP-2, bovine Type I collagen or other components of the formulation
  2. Known hypersensitivity to titanium
  3. Operative site is in the area of a resected or extant tumor
  4. Any active malignancy or current treatment for a malignancy
  5. Active infection at operative site
  6. History of prior exposure to rhBMP-2/ACS
  7. Received and failed a previous alveolar ridge augmentation procedure
  8. Pathology that would either compromise a bone grafting procedure, or interfere with obtaining quantitative measurements from postoperative computer tomography scans
  9. Significant untreated periodontal disease (> Grade III), caries, or chronic inflammation of the oral cavity at operative site
  10. Active use of any nicotine-containing products such as, but not limited to, smoking and chewing tobacco, nicotine patch, nicotine gum, etc.
  11. Insulin-dependent diabetic, or has known glycated hemoglobin (HgbA1c) levels >6.5 %
  12. History of malignancy within the past 5 years except for basal cell or squamous cell carcinoma of the skin
  13. Patients who are lactating
  14. History of metabolic bone disease, excluding idiopathic osteoporosis
  15. History of autoimmune disease (e.g., documented multiple allergies, systemic lupus erythematosus, dermatomyositis, etc.) or immunosuppressive disease (e.g., human immunodeficiency virus or acquired immunodeficiency syndrome)
  16. History of immune deficiency due to other treatments (e.g., radiation therapy, chemotherapy, steroid therapy)
  17. History of adverse reaction to prior exposure to silicone or injectable collagen
  18. Treatment with an investigational therapy within 1 month before the surgical procedure or plans to be treated with an investigational therapy during the study period.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00991432

Locations
United States, California
Los Angeles, California, United States, 90049
Los Angeles, California, United States, 90095
United States, Colorado
Greenwood Village, Colorado, United States, 80111
United States, Florida
Sarasota, Florida, United States, 34237
United States, Illinois
Chicago, Illinois, United States, 60611
United States, Indiana
Lafayette, Indiana, United States, 47904
United States, North Carolina
Denver, North Carolina, United States, 28037
United States, Oregon
Portland, Oregon, United States, 97221
Sponsors and Collaborators
Medtronic Spinal and Biologics
Averion International Corporation
  More Information

No publications provided

Responsible Party: Medtronic Spinal and Biologics
ClinicalTrials.gov Identifier: NCT00991432     History of Changes
Other Study ID Numbers: P09-04
Study First Received: October 6, 2009
Last Updated: February 15, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Medtronic Spinal and Biologics:
Alveolar Ridge Augmentation
Dental Implantation, Endosseous
Osseointegration
Space Maintenance
Bone Morphogenetic Proteins

Additional relevant MeSH terms:
Alveolar Bone Loss
Bone Resorption
Bone Diseases
Musculoskeletal Diseases
Periodontal Atrophy
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on September 22, 2014