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OBJECTIVES To assess the effect of immediate provisionalization (IP) on soft tissue changes, hard tissue changes and clinical parameters following single immediate implant placement (IIP). MATERIALS AND METHODS Two independent reviewers conducted an electronic literature search in Pubmed, Web of Science, Embase and Cochrane databases as well as a manual search to identify eligible clinical studies up to September 2021. Randomized Controlled Trials (RCTs) comparing IIP with IP (test) to IIP without IP (control) were included for a qualitative and quantitative analysis. The primary outcome was vertical midfacial soft tissue changes. Secondary outcomes included horizontal midfacial soft tissue changes, implant survival, mesial and distal papillary changes, Pink Esthetic Score (PES) at final follow-up, marginal bone level changes, probing depth at final follow-up, and bleeding on probing at final follow-up. RESULTS Out of 8213 records, 7 RCTs were selected reporting on 323 patients who received 323 single immediate implants (IIP + IP: 161 implants in 161 patients; IIP: 162 implants in 162 patients) with a mean follow-up ranging from 12 to 60 months. Risk of bias assessment yielded some concerns for 5 RCTs and high risk for 2 RCTs. Meta-analysis on the cases with intact alveoli demonstrated 0.87 mm (95 % CI [0.57; 1.17], p < 0.001) less apical migration of the midfacial soft tissue level for IIP + IP when compared to IIP alone. Implant survival, papillary changes, marginal bone level changes, probing depth and bleeding on probing were not significantly affected by IP. Insufficient data were available for meta-analyses on horizontal midfacial soft tissue changes and PES. CONCLUSION IP may contribute to midfacial soft tissue stability at immediate implants. However, high-quality RCTs are needed since the strength of this conclusion is currently rated as low according to GRADE guidelines. This article is protected by copyright. All rights reserved.