A prospective clinical study to evaluate the performance of zirconium dioxide dental implants in single-tooth edentulous area: 3-year follow-up.

ABSTRACT

BACKGROUND: Traditionally, dental implants have been made from titanium or titanium alloys. Alternatively, zirconia-based ceramic implants have been developed with similar characteristics of functional strength and osseointegration. Ceramic implants offer advantages in certain settings, e.g. in patients who object to metal dental implants. The aim of this study was to investigate the mid-term (36 months) clinical performance of a ceramic monotype implant in single-tooth edentulous area. METHODS: This was a prospective, open-label, single-arm study in patients requiring implant rehabilitation in single-tooth edentulous area. Ceramic implants (PURE Ceramic Implant, Institut Straumann AG, Basel, Switzerland) with a diameter of 4.1 mm were placed following standard procedure and loaded with provisional and final prostheses after 3 and 6 months, respectively. Implant survival rate and implant success rate were evaluated and crestal bone levels were measured by analysing standardized radiographs during implant surgery and at 6, 12, 24 and 36 months. RESULTS: Forty-four patients received a study implant, of whom one patient withdrew consent after 3 months. With one implant lost during the first 6 months after surgery, the implant survival rate was 97.7% at 6 months. No further implants were lost over the following 30 months, and 3 patients were lost to follow-up during this time frame. This led to a survival rate of 97.5% at 36 months. Six months after implant surgery 93.0% of the implants were considered "successful", increasing to 97.6% at 12 months and remaining at this level at 24 months (95.1%) and 36 months (97.5%). Bone loss was most pronounced in the first half-year after implant surgery (0.88 ± 0.86 mm). By contrast, between 12 and 36 months the mean bone level remained stable (minimal gain of 0.06 [± 0.60] mm). Hence, the overall bone loss from implant surgery to 36 months was 0.97 (± 0.88) mm. CONCLUSIONS: In the follow-up period ceramic implants can achieve favourable clinical outcomes on a par with titanium implants. For instance, these implants can be recommended for patients who object to metal dental implants. However, longer term studies with different edentulous morphology need to confirm the present data. TRIAL REGISTRATION Registered on www.clinicaltrials.gov NCT02163395 .