In the present multi‐center study. non‐submerged ITI implants were prospectively followed to evaluate their long‐term prognosis in fully and partially edentulous patients. In a total of 1003 patients, 2359 implants were consecutively inserted. Following a healing period of 3–6 months, the successfully integrated implants were restored with 393 removable and 758 fixed restorations. Subsequently, all consecutive implants were documented annually up to 8 years. At each examination, the clinical status of all implants was evaluated according to predefined criteria of success. Therefore, the data base allowed the evaluation of 8‐year cumulative survival and success rates for 2359 implants. In addition, cumulative success rates were calculated for implant subgroups divided per implant type, implant length. and implant location. Furthermore, the actual 5‐year survival and success rates could be determined for 488 implants. During the healing period, 13 implants did not successfully integrate, whereas 2346 implants fulfilled the predefined criteria of success. This corresponds with an early failure rate of 0.55%. During follow‐up, 19 implants were classified as failures due to several reasons. In addition, 17 implants (= 0.8%) demonstrated at the last annual examination a suppurative periimplant infection. Including 127 drop out implants (= 5.4% drop out rate) into the calculation, the 8‐year cumulative survival and success rates resulted in 96.7% and 93.3%, respectively. The analysis of implant subgroups showed slightly more favorable cumulative success rates for screw type implants (> 95%) compared to hollow‐cylinder implants (91.3%). and clearly better success rates for mandibular implants (= 95%) when compared to maxillary implants (= 87%). The actual 5‐year survival and success rates of 488 implants with 98.2% and 97.3%. respectively, were slightly better than the estimated 5‐year cumulative survival and success rates of 2359 implants indicating that the applied life table analysis is a reliable statistical method to evaluate the long‐term prognosis of dental implants. It can be concluded that non‐submerged ITI implants maintain success rates well above 90% in different clinical centers for observation periods up to 8 years.
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.
ITI dental implants placed in the posterior jaw demonstrate excellent long-term clinical success. Hollow-cylinder implants seem to display a higher risk for crestal bone loss. Recession depth and attachment levels appear to be good clinical indicators of peri-implant bone loss.
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