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TerminatedNCT00991393SinusDIUpdated Feb 17, 2012

Sinus Augmentation With Dental Implant

An observational study in Maxillary Sinus Bone Loss, sponsored by Medtronic Spinal and Biologics. Terminated at 5 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 (part of Medtronic) · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
23
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this research study is to shorten the treatment time course for patients who are scheduled for surgery to have a sinus lift and dental implant(s) placed into the upper front part of their mouth, and need to have more bone in their jaws and a thicker sinus floor to support the implant.

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 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 and a sinus lift, in a single procedure.

02

Conditions studied

  • Maxillary Sinus Bone Loss

Keywords

  • Maxillary Sinus Augmentation
  • Dental Implantation
  • Osseointegration
  • Bone Morphogenetic Proteins
03

In context

Lead sponsor

Medtronic Spinal and Biologics is the lead sponsor of 57 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 sinus augmentation (sinus lift) concurrent with placement of dental implants

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Able to provide written informed consent
  2. ≥ 18 years
  3. Requires and receives sinus augmentation as part of the scheduled dental implantation into the maxillary alveolar ridge
  4. Negative urine pregnancy test for patients of child bearing potential and agreement to not 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 sinus 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 3), 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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
23 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 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 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.

06

What researchers measure

Primary outcomes

  1. Clinical stability and osseointegration of endosseous dental implants

    Time frame: 6 months post-implantation

Secondary outcomes

  1. Evidence of successful INFUSE® Bone Graft placement, as well as the safety of INFUSE® when used in sinus augmentation which will be confirmed by CT scans.

    Time frame: 6 months post-implantation

07

Study locations

5 sites
  • Fullerton, California 92835, United States
  • Denver, North Carolina 28037, United States
  • Philadelphia, Pennsylvania 19104, United States
  • Dallas, Texas 75246, United States
  • Houston, Texas 77063, United States
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Oct 2009, a primary completion of Jan 2011 and a completion of Jan 2011. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 6, 2009
First posted
Oct 8, 2009
Start
Oct 2009
Primary completionActual
Jan 2011
CompletionActual
Jan 2011
Last update
Feb 17, 2012
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
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
NCT00991393
Collaborators
Averion International Corporation
Responsible party
Sponsor
First posted
Oct 8, 2009
Start date
Oct 2009
Primary completion
Jan 2011
Completion
Jan 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 Oct 2011. You cannot join it, but the record below documents what was studied.

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