Patient Reported Outcome Measures (PROMs) of posterior single-implant crowns using digital workflows: A randomized controlled trial with a three-year follow-up

Abstract

Objectives: The aim of this RCT was to analyze Patient Reported Outcome Measures (PROMs) of implant crowns processed in complete digital workflows (test) and combined analog-digital workflows (control) with a three-year follow-up. This is a second reporting from the same trial with sample size calculation based on time efficiency.

Materials and methods: Twenty participants were selected for single-tooth replacement with screw-retained crowns in posterior sites (Straumann TL Implant System). Ten patients each were treated with test or control workflows and evaluated after 1 week of prosthetic delivery (baseline) and 3 years. The subjective opinion of the patient was assessed using visual analog scales (VAS) for PROMs; the Functional Implant Prosthodontic Score (FIPS) for the objective evaluation of the dentist. Wilcoxon signed-rank tests and Mann-Whitney U-tests were used for comparisons between test and control with a level of significance set at α = 0.05.

Results: In test and control, implant crowns showed 100% survival without technical and/or biological complications. Mean PROMs varied between 81.6 and 90.3 with no difference between test and control, or between baseline and after 3 years for intra-patient comparison. Linear regression analysis exhibited a significant correlation between FIPS and PROMs related to overall treatment satisfaction (VAS-1: coefficient 0.45; p = 0.0472).

Conclusion: Subjective patient's perception (PROMs) of posterior implant crowns processed in complete digital and combined analog-digital workflows revealed comparable high levels of satisfaction on the overall treatment outcome including function, esthetics, and cleanability after 3 years. The objective evaluation of the dentist (FIPS) seems to reflect the perception of the patients.

Keywords: crowns; dental implants; digital workflow; patient reported outcome research; patient satisfaction; patient-centered outcome.