Localized Alveolar Ridge Augmentation With Dental Implant (RidgeDI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00991965
Recruitment Status : Terminated
First Posted : October 8, 2009
Last Update Posted : February 17, 2012
Averion International Corporation
Information provided by (Responsible Party):
Medtronic Spinal and Biologics

Brief Summary:
The purpose of this research study is to shorten the treatment time course for 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.

Condition or disease Intervention/treatment
Alveolar Bone Loss Device: INFUSE® Bone Graft

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 shorten the treatment time course for the patients. This post-market study has been designed to further evaluate the effectiveness and safety of INFUSE® Bone Graft, along with dental implant placement, in a single procedure.

Study Type : Observational
Actual Enrollment : 8 participants
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 Dental Implant Placement
Study Start Date : October 2009
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bone Grafts
U.S. FDA Resources

Group/Cohort Intervention/treatment
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 in the area of the dental implant 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 6 months after surgery for placement of the appropriate prosthetic, and assessment of osseointegration and stability. Between the follow-up visit and the EOS visit, patients will be seen as per the SOC schedule for the facility.

Primary Outcome Measures :
  1. Stability and osseointegration of endosseous dental implants [ Time Frame: 6 months post-implantation ]

Secondary Outcome Measures :
  1. Evaluate evidence of successful initial INFUSE® Bone Graft and dental implant placement. Assess percent bone fill within the defect and safety of INFUSE®. Outcomes will be assessed via CT scans and periapical X-rays. [ Time Frame: 6 months post-implantation ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients needing bone augmentation of the alveolar ridge prior to placement of dental implants

Inclusion Criteria:

  1. Able to provide written informed consent
  2. ≥18 years
  3. Scheduled for dental implant into maxillary alveolar ridge
  4. Negative urine pregnancy test for patients of child bearing potential and agreement not become pregnant for at least 12 months after surgery
  5. Is 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 CT 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 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 Immune Deficiency 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00991965

United States, California
Loma Linda, California, United States, 92350
Los Angeles, California, United States, 90095
United States, Florida
Sarasota, Florida, United States, 34237
United States, North Carolina
Denver, North Carolina, United States, 28037
United States, Oregon
Portland, Oregon, United States, 97221
United States, Texas
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Medtronic Spinal and Biologics
Averion International Corporation

Responsible Party: Medtronic Spinal and Biologics Identifier: NCT00991965     History of Changes
Other Study ID Numbers: P09-03
First Posted: October 8, 2009    Key Record Dates
Last Update Posted: February 17, 2012
Last Verified: October 2011

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

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