AIM: To assess the impact of the timing of soft tissue augmentation on soft tissue changes and esthetic outcome following single immediate implant placement (IIP) in the anterior maxilla. MATERIALS AND METHODS: Patients with a failing tooth and intact buccal bone wall in the anterior maxilla (15-25) were enrolled in this RCT. Following single IIP and socket grafting, they were randomly allocated to the control group (immediate soft tissue augmentation performed in the same surgical procedure-ISTA) or the test group (delayed soft tissue augmentation performed 3 months later-DSTA). Implants were placed with a surgical guide and immediately restored with an implant-supported provisional crown. Changes in soft tissue dimensions were assessed by a blinded clinician using superimposed STL files taken prior to surgery and at 1-year follow-up. The esthetic outcome was rated by a blinded clinician and the patient at 1-year follow-up. The study adhered to the STA-COSM (Soft Tissue Augmentation-Core Outcome Set and Measurements for implant dentistry trials) guidelines. RESULTS: Twenty patients were randomized to each group (control: 16 females, 4 males, mean age 57.6
test: 9 females, 11 males, mean age 54.2). The mean change in buccal soft tissue profile was -0.251 and 0.083 mm for ISTA and DSTA, respectively. The mean difference of -0.318 mm in favor of DSTA was not significant (95% CI: -0.860 to 0.224, p = 0.241). Median midfacial recession was -0.200 and - 0.350 mm for ISTA and DSTA, respectively. The median difference of 0.200 mm in favor of ISTA was not significant (95% CI: -0.210 to 0.700, p = 0.311). Mesial and distal papillary recession, Pink Esthetic Score and patients' esthetic satisfaction failed to demonstrate a significant difference between the groups. CONCLUSION: In patients with an intact buccal bone wall, the timing of soft tissue augmentation following IIP had no significant impact on soft tissue changes and esthetic outcome. TRIAL REGISTRATION: ClinicalTrials.gov: NCT05537545.