Prospective 10-Year Cohort Study Based on a Randomized Controlled Trial (RCT) on Implant-Supported Full-Arch Maxillary Prostheses. Part 1: Sandblasted and Acid-Etched Implants and Mucosal Tissue

Background: There have been very few long-term controlled studies (i.e., over 5 years duration) focusing on marginal conditions for implants with a sandblasted, large grit, and acid-etched (SLA) surface. Purpose: To evaluate and report 10-year data on outcomes of implants with an SLA surface placed in the edentulous maxilla. Materials and Methods: In a randomized controlled trial (RCT) cohort of 24 patients, the outcomes of implants with an SLA surface were registered. The RCT cohort has previously been reported after 1 year, 3 years, and 5 years of loading. Results: One patient dropped out of the study prior to the 10-year control. Of the 23 remaining patients, the implant survival rate was 95.1%. If implants of unknown status were also considered lost, that is, one drop-out patient with three implants for whom no information could be obtained, the implant survival rate was 93%. The mean marginal bone loss from baseline (139 implants) to 10 years (102 implants) was 1.07 mm (standard deviation 0.98). One implant out of 102 available for radiographic examination according to the original protocol showed a bone loss exceeding 4 mm. Of the 84 implants available for clinical examination, none showed a Plaque Index or sulcus bleeding index of 3. The mean implant stability quotient was significantly higher for mesialdistal versus buccalpalatal measurements. Conclusion: The implant survival was 95.1%. The mean value of bone loss after 10 years was 1.07 mm. Peri-implantitis were noted at the 5-year follow-up for one patient with a previous history of periodontitis; this patient did not attend the 10-year follow-up. This study shows that sandblasted and acid-etched implants offers predictable long-term results as support for full-arch maxillary prostheses.