Localized Alveolar Ridge Augmentation With Space Maintenance Devices
Ridge Mesh
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
1 other identifier
observational
10
1 country
8
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Oct 2009
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2009
CompletedFirst Submitted
Initial submission to the registry
October 6, 2009
CompletedFirst Posted
Study publicly available on registry
October 8, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2011
CompletedFebruary 17, 2012
September 1, 2011
1.4 years
October 6, 2009
February 15, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Alveolar ridge bone formation sufficient to place endosseous implants
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.
approximately 6 months post-surgery
Study Arms (1)
INFUSE® Bone Graft
all study participants will receive INFUSE® Bone Graft
Interventions
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.
Eligibility Criteria
Patients needing bone augmentation of the alveolar ridge
You may qualify if:
- Able to provide written informed consent
- ≥ 18 years
- Scheduled for dental implant into anterior maxillary alveolar ridge
- Negative urine pregnancy test for patients of child bearing potential and agreement not to 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 alveolar ridge 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 III), 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 glycated hemoglobin (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 immunodeficiency syndrome)
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Medtronic Spinal and Biologicslead
- Averion International Corporationcollaborator
Study Sites (8)
Unknown Facility
Los Angeles, California, 90049, United States
Unknown Facility
Los Angeles, California, 90095, United States
Unknown Facility
Greenwood Village, Colorado, 80111, United States
Unknown Facility
Sarasota, Florida, 34237, United States
Unknown Facility
Chicago, Illinois, 60611, United States
Unknown Facility
Lafayette, Indiana, 47904, United States
Unknown Facility
Denver, North Carolina, 28037, United States
Unknown Facility
Portland, Oregon, 97221, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
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
March 1, 2011
Study Completion
March 1, 2011
Last Updated
February 17, 2012
Record last verified: 2011-09