Small-diameter titanium grade IV and titanium-zirconium implants in edentulous mandibles: Ten-year results from a double-blind, randomised controlled split-mouth core-trial

UNLABELLED: The goal of this extension study was to compare the 10-year outcome of 3.3 mm diameter titanium-zirconium (TiZr) or grade IV titanium (Ti) implants in mandibular implant-overdentures. MATERIALS AND METHODS: This study is the 10-year follow-up from a randomised, controlled, double-blind, split-mouth multicentre clinical trial. Patients with edentulous mandibles had received two implants in the interforaminal region (bone-level, diameter 3.3 mm, microrough surface), one of TiZr (test) and one of Ti (control). Implant survival and success, plaque and sulcus bleeding indices, probing pocket depth, gingival margin, clinical attachment level and radiographic crestal bone levels were evaluated. RESULTS: Fifty of 91 patients with implants were available for the 10-year examination and 36 patients were valid for the intent-to-treat (ITT) analysis. The implant success rate was calculated as 94.6% and 91.9% for the TiZr implants and the Ti implants respectively. Four implants were lost (TiZr = 1; Ti = 3) in the entire study period. Kaplan-Meier survival analyses estimated 10- year implant survival rate for TiZr to 98.9% and Ti 95.8%.The mean of total and functional crestal bone loss was 1.49 mm (±1.37 mm) and 0.82 mm (±1.09 mm) in the TiZr group and 1.56 mm (±1.34 mm) and 0.85 mm (±1.16 mm) in the Ti group. CONCLUSIONS: This split-mouth design RCT on mandibular implant-overdentures evidenced, bearing in mind its follow-up time-related reduced cohort size, high 10-year implant success- and survival rates. These results confirm TiZr as well-suited implant material for realising small-diameter implants. Registered on www. CLINICALTRIALS: gov: NCT01878331.