Quintessence Int 44 (2013), No. 7 6. June 2013
Quintessence Int 44 (2013), No. 7 (06.06.2013)
Page 499-512, doi:10.3290/j.qi.a29611, PubMed:23616977
A prospective noninterventional study to document implant success and survival of the Straumann Bone Level SLActive dental implant in daily dental practice
Filippi, Andreas / Higginbottom, Frank L. / Lambrecht, Thomas / Levin, Barry P. / Meier, Josef L. / Rosen, Paul S. / Wallkamm, Beat / Will, Christoph / Roccuzzo, Mario
Objectives: Clinical studies to assess dental implants are common in implantology, but such studies are usually performed for specific indications and following a specific protocol with strict inclusion and exclusion criteria. The aim of the current study was to evaluate the Straumann Bone Level SLActive dental implant in a prospective, multicenter, noninterventional trial.
Method and Materials: The implant could be used in whatever manner was deemed suitable by the clinician, within approved indications. No particular placement or loading protocol was specified. A total of 1,532 implants were placed in 852 patients in 123 centers in nine countries in the US and Europe. After exclusion of three countries due to patient enrollment and data issues, 759 patients with 1,355 implants were analyzed.
Results: Most patients received one or two implants (58.6% and 25.3% of patients, respectively), and 90% of cases were performed with a raised flap. A submerged healing protocol was significantly more prevalent in European centers, while transmucosal healing was significantly more prevalent in North American centers. After 1 year, 538 patients with 908 implants were available for evaluation. The cumulative implant survival and success rates were 98.5% and 96.0%, respectively.
Conclusions: This prospective noninterventional study evaluated the use of Straumann Bone Level SLActive dental implants in a large number of patients. The cumulative survival and success rates were similar to those observed in controlled clinical trials, confirming this dental implant's clinical applicability in daily practice.
Keywords: bone level dental implant, daily dental practice, noninterventional study, SLActive