Outcome measures and methods of assessment of soft-tissue augmentation interventions in the context of dental implant therapy: A systematic review of clinical studies published in the last 10 years

Aim The aim of the study was to identify and report outcome measures and methods of assessment on soft-tissue augmentation interventions in the context of dental implant therapy reported in clinical studies published in the last 10 years. Material and Methods The protocol of this PRISMA 2020-compliant systematic review was registered in PROSPERO (CRD42021252214). A literature search was conducted to identify articles that met the pre-established eligibility criteria. Data of interest, with an emphasis on outcome measures, were extracted. For each outcome, specific methods and timing of assessment were described in detail. Following a critical qualitative analysis of the data, outcome measures were categorized. Primary outcomes were identified and the frequency of reporting in the selected articles was calculated. Additionally, risk of bias assessments were performed for individual articles and primary outcomes. Results Ninety-two articles, of which 39 reported randomized controlled trials (RCTs), 20 reported non-RCTs, and 33 reported case series studies, were selected. Outcome measures were categorized into either investigator-evaluated outcome measures (i.e., clinical, digital imaging, esthetic, histologic, biomarker, and safety) or patient-reported outcome measures (PROMs). Clinical outcomes were the most frequently reported type of outcome. Considering all categories, the most frequently reported primary outcomes were facial mucosa thickness assessed with clinical methods (22.83%), facial keratinized mucosa width assessed with clinical methods (19.57%), facial mucosal margin position/recession assessed with clinical methods (18.48%), facial mucosa thickness assessed with digital imaging methods (11.96%), facial soft-tissue volume assessed with digital imaging methods (9.78%), and supracrestal tissue height assessed with clinical methods (9.78%). No distinguishable patterns of association between specific types or quality (level of bias) of clinical studies and the choice of primary outcomes were observed. Conclusion Clinical research on peri-implant soft-tissue augmentation has progressively increased in the last 10 years. Although clinical outcome measures were the most frequently reported outcomes in the selected literature, trends in the field are indicative of a shift from traditional clinical assessment methods to the use of digital technologies. PROMs were generally underreported but should be considered an integral methodological component in future clinical studies.