Immediate Provisionalization of NanoTite Implants in Support of Single‐Tooth and Unilateral Restorations: One‐Year Interim Report of a Prospective, Multicenter Study

Abstract

Clinical studies reporting immediate loading of endosseous implants for edentulous cases and for fixed partial restorations have been well documented with satisfactory survival rates. Implants with a recently developed, nanometer-scale surface topography (NanoTite, BIOMET 3i, Palm Beach Gardens, FL, USA), created by discrete crystalline depositions (DCD) of calcium phosphate nano-crystals onto a dual acid-etched (DAE) surface, show enhanced early fixation in preclinical studies when compared with DAE-surfaced implants. These outcomes suggest DCD-surfaced implants may be advantageous for immediate loading approaches. The aim of this prospective, multicenter, observational study is to report clinical outcomes for DCD-surfaced implants placed in immediate functional support of single- and multi-unit restorations according to an immediate loading protocol. One hundred eighty-five patients enrolled at 15 international study centers received a total of 335 implants supporting 216 immediate provisionalizations consisting of 128 single-tooth restorations and 88 fixed restorations. Of the 335 implants, 77% are located in posterior and 23% in anterior regions with 55.5% of the total in mandibles and 44.5% in maxillae. Patients were evaluated for implant mobility, gingival health, symptomatology, and radiographic outcomes. At the time of this 1-year interim report, a total of 17 failures have been observed in 11 patients, yielding a cumulative survival rate of 94.9%. Relative to other prospective, multicenter studies of immediately loaded implants with various surface enhancements, NanoTite implants perform comparatively well when immediately provisionalized with single-tooth and fixed restorations.