Sinus Augmentation With Dental Implant

NCT00991393 | Terminated

• 1 other identifier: P09-05
• Study Type: observational
• Target: 23
• Locations: 1 country
• Sites: 5

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 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.

Conditions

Maxillary Sinus Bone Loss

Keywords

Maxillary Sinus Augmentation; Dental Implantation; Osseointegration; Bone Morphogenetic Proteins

Outcome Measures

Primary Outcomes (1)

• Clinical stability and osseointegration of endosseous dental implants

  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.

  6 months post-implantation

Study Arms (1)

INFUSE® Bone Graft

all study participants will receive INFUSE® Bone Graft

Device: INFUSE® Bone Graft

Interventions

INFUSE® Bone Graft DEVICE

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.

INFUSE® Bone Graft

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients needing sinus augmentation (sinus lift) concurrent with placement of dental implants

You may qualify if:

• Able to provide written informed consent
• ≥ 18 years
• Requires and receives sinus augmentation as part of the scheduled dental implantation into the maxillary alveolar ridge
• Negative urine pregnancy test for patients of child bearing potential and agreement to not become pregnant for at least 12 months after surgery
• Able to comply with all study-related procedures, including exercising good oral hygiene
• A prosthodontic treatment plan has been drafted.

You may not qualify if:

• Known hypersensitivity to rhBMP-2, bovine Type I collagen or other components of the formulation
• Known hypersensitivity to titanium
• Operative site is in the area of a resected or extant tumor
• Any active malignancy or current treatment for a malignancy
• Active infection at operative site
• History of prior exposure to rhBMP-2/ACS
• Received and failed a previous sinus augmentation procedure
• Pathology that would either compromise a bone grafting procedure, or interfere with obtaining quantitative measurements from postoperative computer tomography scans
• Significant untreated periodontal disease (\> Grade 3), caries, or chronic inflammation of the oral cavity at operative site
• Active use of any nicotine-containing products such as, but not limited to, smoking and chewing tobacco, nicotine patch, nicotine gum, etc.
• Insulin-dependent diabetic, or has known HgbA1c levels \>6.5 %
• History of malignancy within the past 5 years except for basal cell or squamous cell carcinoma of the skin
• Patients who are lactating
• History of metabolic bone disease, excluding idiopathic osteoporosis
• 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)

Sponsors & Collaborators

• Medtronic Spinal and Biologics: lead
• Averion International Corporation: collaborator

Study Sites (5)

Unknown Facility

Fullerton, California, 92835, United States

Location

Unknown Facility

Denver, North Carolina, 28037, United States

Location

Unknown Facility

Philadelphia, Pennsylvania, 19104, United States

Location

Unknown Facility

Dallas, Texas, 75246, United States

Location

Unknown Facility

Houston, Texas, 77063, United States

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2009
• First Posted: October 8, 2009
• Study Start: October 1, 2009
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: February 17, 2012

Record last verified: 2011-10

Locations

US (5)