Localized Alveolar Ridge Augmentation With Dental Implant

NCT00991965 | Terminated

• 1 other identifier: P09-03
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 6

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.

Conditions

Alveolar Bone Loss

Keywords

Alveolar Ridge Augmentation; Dental Implantation, Endosseous; Osseointegration; Bone Morphogenetic Proteins

Outcome Measures

Primary Outcomes (1)

• Stability and osseointegration of endosseous dental implants

  6 months post-implantation

Secondary Outcomes (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.

  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 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.

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 bone augmentation of the alveolar ridge prior to placement of dental implants

You may qualify if:

• Able to provide written informed consent
• ≥18 years
• Scheduled for dental implant into maxillary alveolar ridge
• Negative urine pregnancy test for patients of child bearing potential and agreement not become pregnant for at least 12 months after surgery
• Is 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 CT 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 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 (6)

Unknown Facility

Loma Linda, California, 92350, United States

Location

Unknown Facility

Los Angeles, California, 90095, United States

Location

Unknown Facility

Sarasota, Florida, 34237, United States

Location

Unknown Facility

Denver, North Carolina, 28037, United States

Location

Unknown Facility

Portland, Oregon, 97221, United States

Location

Unknown Facility

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Alveolar Bone Loss

Condition Hierarchy (Ancestors)

Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

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: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: February 17, 2012

Record last verified: 2011-10

Locations

US (6)