A Randomised Controlled Trial Comparing a One‐Piece Zirconia Tissue‐Level Implant and Two‐Piece Titanium Bone‐Level Implant for Maxillary Single Tooth Replacement—3 year Results

ABSTRACT Objectives This RCT evaluated and compared the clinical performance of zirconia and titanium dental implants placed in the maxillary premolar region. Outcomes were assessed 3 years after prosthetic loading and included marginal bone level (MBL) changes, clinical parameters, aesthetic outcomes, and patient related outcome measures (PROMs). Materials and Methods Fifty patients were randomly allocated to receive either a zirconia one‐piece (ZrO 2 , n = 25) implant or a titanium bone‐level (Ti, n = 25) implant, restored with a lithium disilicate crown 3 months after implant placement. Primary outcome was change in MBL. Secondary outcomes included implant survival, peri‐implant tissue health, technical complications, aesthetic outcomes, and PROMs. Examinations were performed 3 years after crown placement. Results After 3 years, mean MBL change was −0.02 mm (SD = 0.78) for ZrO 2 and −0.04 mm (SD = 0.36) for Ti; no statistically significant difference was found ( p = 0.635). One ZrO 2 implant failed to osseointegrate. Clinical parameters were favourable for both implant types, although slightly higher bleeding scores were observed for ZrO 2 . Differences in aesthetic outcomes and PROMs were found, favoring the ZrO 2 implant group. None of these differences reached statistical significance. Conclusion and Clinical Implications After 3 years of function, the ZrO 2 and Ti implant as applied in this study showed comparable MBL changes. Survival, clinical and aesthetic parameters, and PROMs were generally favourable and largely comparable for both groups. These short‐term findings indicate that both implant types represent a viable option for clinical use in this application. Trial Registration CCMO registration: NL58957.042.16