Safety and efficacy of a biomimetic monolayer of permanently bound multi-phosphonic acid molecules on dental implants: 1 year post-loading results from a pilot quadruple-blinded randomised controlled trial.

PURPOSE To evaluate the safety and clinical efficacy of a novel surface treatment (SurfLink®, Nano Bridging Molecules, Gland, Switzerland) on titanium dental implants. SurfLink consists of a monolayer of permanently bound multi-phosphonic acid molecules, which mimics the surface of naturally occurring hydroxyapatite. MATERIALS AND METHODS Twenty-three patients requiring at least two single dental implants had their sites randomised according to a split-mouth design to receive one titanium grade 4 implant treated with SurfLink and one untreated control implant. Additional SurfLink-treated implants were placed if needed. Implants were submerged for 3 months in mandibles and 6 months in maxillae, were loaded with definitive metal-ceramic crowns, and followed up for 1 year after loading. Outcome measures were crown/implant failures, any complication, radiographic peri-implant marginal bone level changes and marginal bleeding. RESULTS One patient dropped out after abutment connection. All remaining patients were followed up to 1 year post-loading. No implant failed and only 1 postoperative complication (pain) occurred, but it may not have been related to the implant treatment. No bleeding was observed when a periodontal probe was used to examine the peri-implant soft tissues around the implants. There were no statistically significant differences in marginal bone level changes between the two groups (P = 0.057, mean difference = -0.27, SE = 0.13; 95% CI -0.55 to 0.01). CONCLUSIONS Preliminary short-term data (1 year post-loading) of implants with a biomimetic monolayer of permanently bound multi-phosphonic acid molecules (SurfLink surface treatment) presented no safety issues. Clinical healing in both the control and SurfLink-treated implant group was uneventful and did not differ significantly between groups. More challenging clinical situations need to be investigated to evaluate the real effectiveness of this surface treatment.