Localized Alveolar Ridge Augmentation With Dental Implant

Alveolar Bone Loss Clinical Trial

— RidgeDI  

Official title:

An Open Label, Non-randomized, Single-arm, Multi-center Study to Assess Localized Alveolar Ridge Augmentation Utilizing INFUSE® Bone Graft Concurrent With Dental Implant Placement

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00991965
• Other study ID #: P09-03
• Status: Terminated
• Phase: N/A
• First received: October 6, 2009
• Last updated: February 15, 2012
• Start date: October 2009
• Est. completion date: November 2010

Study information

• Verified date: October 2011
• Source: Medtronic Spinal and Biologics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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, in a single procedure.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Able to provide written informed consent

2. =18 years

3. Scheduled for dental implant into maxillary alveolar ridge

4. Negative urine pregnancy test for patients of child bearing potential and agreement not become pregnant for at least 12 months after surgery

5. Is able to comply with all study-related procedures, including exercising good oral hygiene

6. A prosthodontic treatment plan has been drafted.

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 CT 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 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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Alveolar Bone Loss

Intervention

Device:
• INFUSE® 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 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Medtronic Spinal and Biologics	Averion International Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stability and osseointegration of endosseous dental implants		6 months post-implantation	No
Secondary	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	Yes