DATA SOURCES: Five electronic databases (PubMed, Embase, Central, Web of Science, and Epistemonikos) and grey literature were systematically searched up to November 22, 2021 to identify studies relevant to patient-reported outcome measures (PROMs) in peri-implant soft tissue augmentation. STUDY SELECTION: Two authors independently reviewed the title, abstrac (screening phase), and full text (eligibility phase) of the articles after removing the duplicates, based on the pre-established inclusion criteria. A total of 29 clinical studies (19 randomized clinical trials, 7 non-randomized studies, and 3 case series) fulfilled the eligibility criteria based on the PICO framework. DATA EXTRACTION AND SYNTHESIS: Data were independently extracted from the included studies by two authors using data extraction tables. The mean values of PROMs were pooled and analyzed with the weighted mean difference (WMD) and 95% confidence intervals (CIs) to summarize and compare the studies. Eleven subgroup meta-analyses (including 2-6 studies in each) were conducted using random-effect models to determine the differences in mean values of PROMs (pain scores on the Visual Analog Scale [VAS], analgesic consumption, satisfaction on VAS, aesthetic perception, surgery duration, and quality of life) between soft tissue autografts and substitutes. RESULTS: For mucosal thickness gain, pain perception was significantly reduced with soft tissue substitutes compared to subepithelial connective tissue graft (SCTG) at both 0-100 (n = 4
WMD = 14.91 VAS units
95% CI: 6.42-23.40
P <
0.0006) and 0-10 VAS scale (n = 4
WMD = 1.62 VAS units
95% CI: 0.01-3.23
P = 0.05). Similar results of significantly reduced pain with soft tissue substitutes on a 0-100 (n = 2
WMD = 21.43 VAS units
95% CI: 12.58-30.28
P <
0.0001) and 0-10 VAS scale (n = 4
WMD = 1.65 VAS units
95% CI: 0.66-2.64
P = 0.001) were found for keratinized tissue gain. Furthermore, with soft tissue substitutes painkiller consumption (n = 6
WMD = 1.56 tablets
95% CI: 1.22-1.91
P <
0.00001) and surgery time (n = 5
WMD = 10.9 min
95% CI: 4.60-17.19
P <
0.00001) were significantly less in comparison to autogenous grafts. Patient satisfaction, aesthetic perception, and quality of life did not differ significantly between soft tissue substitutes and autogenous grafts for soft tissue augmentation around implants. CONCLUSION: PROMs in terms of postoperative pain, analgesic intake, and surgery duration are significantly improved with the use of soft tissue substitutes for peri-implant soft tissue augmentation. Similar levels of patient satisfaction and aesthetic perception were achieved with soft tissue substitutes as with autogenous grafts, without impairing the clinical outcomes.