Clinical Study of INFUSE® Bone Graft Compared to Autogenous Bone Graft for Vertical Ridge Augmentation

NCT01308996 | Withdrawn DMC

• 1 other identifier: G100313
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate the INFUSE® Bone Graft as an alternative to autograft for bone formation in the back of the mandible (lower jaw) prior to placing dental implants.

Conditions

Alveolar Bone Loss in Mandible; Edentulous Alveolar Ridge In Mandible

Keywords

alveolar ridge augmentation; edentulous ridge; alveolar ridge defect; posterior mandible defect; bone morphogenic protein; osseointegration

Outcome Measures

Primary Outcomes (1)

• Osseous volumetric fill underneath the titanium mesh of edentulous sites in the posterior mandible.

  210 days

Secondary Outcomes (5)

• Pain level at the surgical site, as well as at the donor site (if applicable).

  210 days

• Ability to place dental implants

  210 days

• Histological evaluation (percent vital bone)

  210 days

• Surgical failure rate

  210 days

• Adverse Events

  210 Days

Study Arms (2)

INFUSE® Bone Graft

EXPERIMENTAL

Device: INFUSE® Bone Graft

Autogenous bone graft

ACTIVE COMPARATOR

Procedure: Autogenous bone graft from tibia or iliac crest

Interventions

INFUSE® Bone Graft DEVICE

Implantation of INFUSE® Bone Graft \[recombinant human Bone Morphogenetic Protein-2 (rhBMP-2)\] and absorbable collagen sponge (ACS) carrier at 1.50 mg/cc with space maintenance device

INFUSE® Bone Graft

Autogenous bone graft from tibia or iliac crest PROCEDURE

Implantation of autogenous bone graft from iliac crest or tibia with titanium mesh space maintenance device

Autogenous bone graft

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Has been edentulous for at least 2 months with an alveolar ridge defect affecting 2-4 teeth in the posterior mandible, posterior to the canine.
• Has an alveolar ridge defect with a minimum starting height of 5 mm above the superior cortex of the inferior alveolar canal in the posterior mandible.
• Is a candidate for dental implants (2-4 teeth) in the affected posterior mandibular alveolar ridge area.
• Has a prosthodontic treatment plan in place.
• Has no known condition that would interfere with collecting autogenous bone at either the tibia or the iliac crest for a bone grafting procedure.
• Is 21-75 years of age (inclusive).
• If female of childbearing potential, has a negative urine pregnancy test, is not lactating, and agrees not to become pregnant for at least 12 months after surgery.
• Is able to comply with all study-related procedures, including exercising good oral hygiene.
• Is able to provide written informed consent.

You may not qualify if:

• Has bilateral alveolar ridge defects requiring simultaneous augmentation or a second augmentation planned during the course of the study.
• Has an active infection at the planned augmentation site.
• Has active periodontal disease of Grade III or higher.
• Has had a dental extraction procedure at the planned augmentation site within the 2 months prior to Day 0.
• Has had a soft tissue graft at the planned augmentation site within less than 2 weeks of Screening.
• Is expected to require any additional bone graft material (e.g., allograft and xenograft) at the planned augmentation site in addition to the investigative treatment or autogenous bone, as determined by the investigator prior to surgery.
• Has a history of a failed alveolar ridge augmentation procedure.
• Has a pathology finding that would either compromise a bone grafting procedure or interfere with obtaining quantitative measurements from postoperative CT scans.
• Is an insulin-dependent diabetic.
• Has an overt or active systemic infection, such as human immunodeficiency virus (HIV), bacteremia, or hepatitis C virus (HCV).
• Has a planned augmentation site in the area of a resected or extant tumor.
• Has presence of an active malignancy or prior history of malignancy (except for basal cell carcinoma of the skin).
• Is actively using any nicotine-containing products such as, but not limited to, smoking and chewing tobacco, nicotine patch, nicotine gum, etc. within 2 weeks prior to Screening.
• Is alcohol or drug dependent, as determined by the investigator.
• Is taking medications or having treatment known to have an effect on bone metabolism, such as, but not limited to:

Sponsors & Collaborators

• Medtronic Spinal and Biologics: lead
• Averion International Corporation: collaborator
• Baim Institute for Clinical Research: collaborator

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2011
• First Posted: March 4, 2011
• Study Start: April 1, 2012
• Primary Completion: July 1, 2017
• Study Completion: September 1, 2017
• Last Updated: September 13, 2018

Record last verified: 2012-08