At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Molecular and Cellular Comparison of Bone Inductive Properties Of Trabecular Metal® Vs. Titanium Among Healthy, Diabetic, and Osteopenic Subjects
In Brief
A clinical study evaluating Zimmer Trabecular Metal Test Cylinder and Zimmer Titanium Test Cylinder for Tooth Replacement. Completed, enrolled 42 participants across 1 site.
Detailed Summary
The purpose of this research study is to compare the healing differences of two metals (trabecular vs. standard titanium) that are used for dental implants. In addition; investigators will be examine these differences in the gene expression profiles in subjects with three conditions associated with delayed healing: diabetes and osteoporosis. The study will last at least 11 weeks consisting of 6 appointments. All visits will be carried out at the GO Health Center within the UNC School of Dentistry. Visits will last between 30 minutes to 3 hours depending on the particular visit. The visits will consist of: Obtaining consent, doing a health history, measuring vital signs, doing dental exams of the teeth and gums, collecting samples of saliva dental radiographs (X-rays), a teeth cleaning, having 4 temporary mini test cylinders placed in areas of the lower jaw where teeth are missing and implant surgery to place up to four permanent implants.
Study Details
Timeline
Interventions
For all subjects 2 titanium and 2 trabecular 2.9-3.0 mm x 5 mm test cylinders will be implanted in alveolar bone. One of each type will be removed at 2 weeks. The remaining two will be removed at 4 weeks.
For all subjects 2 titanium and 2 trabecular 2.9-3.0 mm x 5 mm test cylinders will be implanted in alveolar bone. One of each type will be removed at 2 weeks. The remaining two will be removed at 4 weeks.