The use of reduced healing times on ITI® implants with a sandblasted and acid‐etched (SLA) surface: Early results from clinical trials on ITI® SLA implants

Abstract

Summary: ITI® dental implants are available with two bone‐anchoring surfaces, a titanium plasma‐sprayed (TPS) surface, and a recently introduced sandblasted and acid‐etched (SLA) surface. Cell culture and animal tests demonstrate that the SLA surface stimulates bone cell differentiation and protein production, has large amounts of bone‐to‐implant contact, and results in large removal torque values in functional testing of the bone contact. As a result of these studies, a prospective human clinical trial was initiated to determine whether the 4.1 mm diameter SLA ITI® solid screw implants could be predictably and safely restored as early as six weeks after implant placement surgery. The protocol restricted the use of the reduced healing time to a) healthy patients with sufficient bone volume to surround the implant, and b) those patients who had good bone quality (classes I‐III) at the implant recipient site. Patients with poorer bone quality (class IV) did not have restorations until 12 weeks after implant placement. The clinical trial is an ongoing multicenter trial, with six centers in four countries, and with follow‐up over five years. The primary outcome variable was abutment placement with a 35 Ncm force, with no countertorque and no pain or rotation of the implant. A secondary outcome was implant success, as defined by no mobility, no persistent pain or infection, and no peri‐implant radiolucency. To date, 110 patients with 326 implants have completed the one‐year post‐loading recall visit, while 47 patients with 138 implants have completed the two‐year recall. Three implants were lost prior to abutment connection. Prosthetic restoration was commenced after shortened healing times on 307 implants. The success rate for these implants, as judged by abutment placement, was 99.3% (with an average healing time of 49 days). Life table analyses demonstrated an implant success rate of 99.1%, both for 329 implants at one year and for 138 implants at two years. In the 24‐month period after restoration, no implant losses were reported for the 138 implants. These results demonstrate that, under defined conditions, solid screw ITI® implants with an SLA endosseous surface can be restored after approximately six weeks of healing with a high predictability of success, defined by abutment placement at 35 Ncm without countertorque, and with subsequent implant success rates of greater than 99% two years after restoration.