A Prospective Multicenter Study Evaluating Loading of Osseotite Implants Two Months After Placement: One-Year Results

Abstract: Historically, the recommended time between placement and functional loading of machined-surface dental implants has been 3 months for the mandible and 6 months for the maxilla. However, such recommendations are a result of evaluating randomly chosen healing times during the initial phase of implant development and are based on the subsequent clinical outcome of either implant integration or mobility. In recent years, histologic and experimental studies have shown that specifically designed micro-topographic implant surfaces can result in increased bone-to-implant contact at earlier healing times than obtained with machined-surface implants. Histologic and clinical studies investigating early and immediate implant loading support the premise that implants can be placed into function earlier than previously recommended. With the development of specifically designed implant surfaces and the utilization of time-saving surgical (one-stage surgical protocol) and prosthetic (implant position indexing) techniques, patients are now being restored and returning to function sooner than previously thought possible. The purpose of this multicenter clinical investigation is to evaluate the efficacy of loading Osseotite dental implants (3i-Implant Innovations Inc., Palm Beach Gardens, Florida) at 2 months and to determine the effect of early loading on implant performance and survival. A total of 429 Osseotite implants were placed in 155 patients (87 females and 68 males; mean age 54.0 ± 13.7 yr), at 10 study centers, and subsequently loaded 2.1 ± 0.7 months following placement. A single-stage surgical protocol was followed, with implants indexed immediately or impressed 4 to 6 weeks following placement. Patient restorative treatments included placement of 83 single-implant provisional restorations and 129 splinted, two-, three-, and four-implant supported maxillary and mandibular provisional restorations. The mean time from prosthetic loading to the most recent follow-up evaluation was 10 ± 1.3 months. Seven of the 429 implants did not integrate; of these, six were identified prior to loading and one was identified 1 month after loading. The cumulative implant survival rate was 98.5% at 12.6 months. The cumulative post-loading implant survival rate was 99.8% at 10.5 months. The preliminary results of this clinical investigation suggest that successful functional loading of the Osseotite dental implant is possible at 2 months following noncomplicated implant placement.