WithdrawnNot Applicable

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

0Started 2012-04

Plain-language 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.

Who can participate

Age range21 Years – 75 Years

SexALL

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Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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.

What they're measuring

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

Timeframe: 210 days

Trial details

NCT IDNCT01308996

SponsorMedtronic Spinal and Biologics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-07

View on ClinicalTrials.gov More Alveolar Bone Loss in Mandible trials