CClinicalTrials.gg
TerminatedNCT00991432Ridge MeshUpdated Feb 17, 2012

Localized Alveolar Ridge Augmentation With Space Maintenance Devices

An observational study in Alveolar Bone Loss, sponsored by Medtronic Spinal and Biologics. Terminated at 8 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-02-17.

Sponsored by Medtronic Spinal and Biologics · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
10
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Alveolar Bone Loss

Browse trials for

Keywords

  • Alveolar Ridge Augmentation
  • Dental Implantation, Endosseous
  • Osseointegration
  • Space Maintenance
  • Bone Morphogenetic Proteins
03

In context

Alveolar Bone Loss

297 studies on the registry are indexed under Alveolar Bone Loss; 76 are open to participants now.

This study's enrollment of 10 is below the median of 54 across 40 observational studies indexed under Alveolar Bone Loss.

Browse Alveolar Bone Loss studies →

Lead sponsor

Medtronic Spinal and Biologics is the lead sponsor of 56 studies on the registry; 3 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 5 (71%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients needing bone augmentation of the alveolar ridge

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
10 participants (actual)

Groups and cohorts

  • INFUSE® Bone Graft

    all study participants will receive INFUSE® Bone Graft

    Device: INFUSE® Bone Graft

Interventions

  • DeviceINFUSE® 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.

06

What researchers measure

Primary outcomes

  1. Alveolar ridge bone formation sufficient to place endosseous implants

    Time frame: approximately 6 months post-surgery

Secondary outcomes

  1. 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

07

Study locations

8 sites
  • Los Angeles, California 90049, United States
  • Los Angeles, California 90095, United States
  • Greenwood Village, Colorado 80111, United States
  • Sarasota, Florida 34237, United States
  • Chicago, Illinois 60611, United States
  • Lafayette, Indiana 47904, United States
  • Denver, North Carolina 28037, United States
  • Portland, Oregon 97221, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 17, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00991432
Lead sponsor
Medtronic Spinal and Biologics
Collaborators
Averion International Corporation
Responsible party
Sponsor
First posted
Oct 8, 2009
Start date
Oct 2009
Primary completion
Mar 2011
Completion
Mar 2011
Last update
Feb 17, 2012

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Sep 2011. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion