Keywords: clinical trial, custom abutment, implant-abutment interface, patient outcomes
Purpose: To evaluate the clinical, radiographic, and prosthetic outcomes of a single custom CAD/CAM abutment system on implants from four manufacturers, with a mean clinical service of 4 years in a retrospective, multicenter case series study.
Materials and methods: Adult subjects (n = 142) previously restored with titanium or gold-shaded titanium nitride custom CAD/CAM abutments (Atlantis, Dentsply Sirona; n = 259) connected to implants from four different manufacturers (Dentsply Sirona Implants [AT], Biomet 3i [BM], Nobel Biocare [NB], Straumann [ST]), irrespective of implant-abutment interface, and replacing one or more teeth in any position were recalled for a single-visit examination by calibrated investigators at six university clinics. The primary outcomes evaluated included abutment success and survival; secondary outcomes included assessment of papillae fill, probing pocket depth (PD), bleeding on probing (BOP), marginal bone levels (MBLs), and patient-reported outcome measures (PROMs).
Results: Two-hundred fifty-five (98.5%) abutments supported cement-retained restorations, and four (1.5%) abutments supported screw-retained restorations. Forty-two patients had 64 AT implants (25%), 31 patients had 61 BM implants (24%), 26 patients had 50 NB implants (19%), and 43 patients had 84 ST implants (32%). The overall implant-CAD/CAM abutment success rate was 92.66% (95% CI: 88.78%, 95.53%) for all implants examined, and the survival rate was 98.84% (95% CI: 96.65%, 99.76%) for all implants evaluated. The Jemt papillae index demonstrated a minimum of at least 50% to complete fill of the interproximal papillae in 65.0% of sites. PDs had a median value of 3.0 mm, and BOP was present on 19% of abutment surfaces. Mean MBL changes from the time of placement to exam were -0.24 ± 0.99 mm (-4.9 to 2.3; P = .058) for mesial sites and -0.32 ± 0.96 mm (-4.9 to 2.1; P = .000) for distal sites. PROMs expressed 93% of patients reporting good to very good masticatory function, 97% of patients reporting being satisfied or very satisfied with their esthetic outcomes, and 94% of patients indicating that they were satisfied or very satisfied with their overall implant-restorative outcomes.
Conclusion: This retrospective, multicenter clinical study of FDA 510k-approved titanium CAD/CAM abutments of a single manufacturer on multiple implant systems demonstrated high levels of success and survival as well as stable peri-implant tissue outcomes, reflected by overwhelmingly positive PROMs.