Patient-reported outcome measures (PROMs) comparing digital and conventional workflows for treatment with posterior single-unit implant restorations: A randomized controlled trial

Abstract

Objectives: The aim of this randomized controlled trial (RCT) was to analyze patient-reported outcome measures (PROMs) of prosthetic therapy with monolithic implant crowns in completely digital workflows (test) with intraoral optical scanning (IOS) and conventional workflows (control) with conventional impressions. Secondary, an objective evaluation of the final implant restorations was performed using the Functional Implant Prosthodontic Score (FIPS).

Materials and methods: Forty patients who required an implant-supported single crown on posterior regions were randomly divided into test (n = 20) and control (n = 20) groups for impression taking. Each group was then equally separated into two subgroups according to the restorative material used: lithium disilicate (LS2, N!CE®, Straumann AG, Basel, Switzerland) or polymer-infiltrated ceramic networks (PICN, Enamic®, Vita, Bad Säckingen, Germany). Patient satisfaction was evaluated using PROM questionnaires with visual analog scales (VAS) after impression-taking and 1 week after prosthetic delivery. Patient satisfaction with the impression technique was assessed in six domains: length, comfort, anxiety, taste, nausea, and pain, whereas patient satisfaction with the final restoration was assessed in four domains: overall treatment outcome, functionality, esthetics, and cleanability. In addition, the final implant restorations were objectively assessed by an independent prosthodontist using the FIPS. Mann-Whitney U test was used to analyze the defined outcomes. Statistical analysis was completed with a level of significance set at α=0.05.

Results: PROMs focusing on the impression technique demonstrated higher levels of patient satisfaction for IOS compared to conventional impressions, especially in terms of "taste irritation" (p = 0.036); whereas no significant differences were found between both restorative CAD/CAM-materials. Mean FIPS values demonstrated similar results among subgroups.

Conclusions: Within the limitation of this study, both completely digital and conventional protocols provided great levels of patient satisfaction in implant rehabilitation of single-tooth gaps in posterior sites with monolithic implant crowns. The restorative material, LS2 versus PICN, does not impact patient satisfaction with their treatment. However, a long-term follow up is needed to draw more specific conclusions on patient satisfaction with the restorations.

Keywords: Clinical Research; Crowns; Dental implant; Digital workflow; Functional implant prosthodontic score (FIPS); Patient-reported outcome measures (PROMs).