Ten Years Later. Results from a Prospective Single-Centre Clinical Study on 121 Oxidized (TiUnite™) Brånemark Implants in 46 Patients

Abstract: Background: Concerns have been raised that use of surface-modified implants may result in peri-implant infection and marked marginal bone loss over time. Purpose: The aim of this prospective study was to evaluate the survival rate, marginal bone, and soft tissue conditions at surface-modified titanium dental implants after 10 years of function. Material and Methods: Forty-six totally and partially edentulous patients were provided with 121 Brånemark oxidized implants (TiUnite™, Nobel Biocare AB, Gothenburg, Sweden). Twenty-four (20%) implants were immediate loaded and 97 (80%) were placed using a two-stage procedure. A total of 22 single, 23 partial, and 7 total restorations were delivered. Clinical and radiographic checkups were carried out after 3, 6, 12 months, and thereafter annually up to 10 years. At these occasions, oral hygiene was evaluated and peri-implant mucosa examined by probing. If needed, patients were enrolled in an individual program for hygiene controls and professional cleaning. Marginal bone loss was evaluated in intraoral radiographs taken at baseline and after 1, 5, and 10 years of function. Results: One (0.8%) implant failed after 8 years giving a Survival Rate (SR) of 99.2% after 10 years. A total of 11 sites (9.2%) showed bleeding on probing (BP) at the 10th annual checkup. The mean marginal bone loss was 0.7 ± 1.35 mm based on 106 readable pairs of radiographs from baseline and from the 10th annual examination. Twelve (11.3%) implants showed more than 2 mm bone loss, and five (4.7%) showed more than 3 mm of bone loss after 10 years. For the latter, all patients were smokers and had poor or acceptable oral hygiene. All five implants with >3 mm bone loss showed BP and two (1.9%) showed suppuration from the pocket. For the remaining seven implants with more than 2 mm bone loss, no correlation to smoking, oral hygiene, bleeding, or pus could be seen. Time/marginal bone level plots of the 12 implants with more than 2 mm bone loss after 10 years, showed minor changes from the first annual checkup except for the two infected implants. Conclusions: It is concluded that good long-term clinical outcomes can be obtained with oxidized titanium dental implants. Only 1.9% of examined implants showed significant marginal bone loss together with bleeding and suppuration after 10 years of function.