The topical administration of bisphosphonates in implant surgery: a randomized split-mouth prospective study with a follow-up up to 5 years.

OBJECTIVE: To evaluate the efficacy of the topical administration of bisphosphonates in implant therapy. MATERIALS AND METHODS: Thirty-nine consecutive patients were selected for a split-mouth study. Inclusion criteria were: presence of a bilateral or total edentulism, ability to tolerate conventional implant procedures, older than 18 years. Ten patients were smokers. Ten patients were fully edentulous in both maxilla and mandible, 12 patients had fully edentulous maxilla or mandible, and 17 were bilaterally partially edentulous (9 in the mandible and 8 in the maxilla). A one-stage procedure was adopted in all cases. The prosthetic phase started 10 weeks after implant insertion. Each patient received implants on the control side and the test side, with insertion performed in the conventional way on the control side; on the test side, a 3% clodronate solution mixed with a surfactant (Tween-20) at a 1:3 ratio was topically administered both at the implant surface and at the implant site. RESULTS: One hundred fifty-five implants were inserted. The test and control groups included 75 and 80 implants, respectively. The implant insertion torque was no less than 30 Ncm. A total of 7 implants failed in the control group (6 before loading and one after 12 months of loading). No failure occurred on the test side. By the 5-year follow-up, no further implant failure had been recorded. Overall, implant survival rates at 5 years for the test and control groups were, respectively, 100% and 91.3%, the difference being significant (p < .01). Mean marginal bone loss was 0.85 +/- 0.71 mm in the test group and 1.12 +/- 0.85 mm in the control group after 1 year of loading and stable thereafter. The difference was not significant. CONCLUSIONS: The topical administration of bisphosphonates may positively affect implant survival in the preloading and postloading phases in partially and fully edentulous patients. However, a larger study population is needed to verify these promising clinical results.