Ten‐year hard and soft tissue results of a pilot double‐blinded randomized controlled trial on immediately loaded post‐extractive implants using platform‐switching concept

Abstract Aim To evaluate the 10‐year post‐loading radiological and esthetic outcomes of implants inserted in post‐extraction sites and restored with or without platform‐switching protocol. Material and methods Twenty‐two patients were scheduled for maxillary post‐extractive implant, using a 13 mm in length and 5.5 mm in diameter implant (Global, Sweden & Martina, Padua, Italy). They randomly received definitive restorations using platform‐switching concept (abutment 3.8 mm in diameter: test group) or standard restoration (abutment 5.5 mm in diameter: control group). Outcome measures were survival rates of implants and prostheses, peri‐implant marginal bone loss and periodontal indices 10 years after prosthetic loading. Moreover, esthetic parameters including soft tissue buccal peri‐implant mucosal levels (REC) and mesial and distal papilla height (PH) were taken at definitive restoration, 2 and 10 years thereafter. Results Nineteen implants were analyzed after 10 years of follow‐up. No implants nor prostheses failed. The postoperative radiographs demonstrated an overall mean bone loss of 0.18 ± 0.14 mm in the test group and of 0.80 ± 0.40 mm in the control group ( P = 0.00108). Test group showed 0.23 ± 0.51 mm of REC gain and PH was of 0.21 ± 0.33 mm on average. On the other side, the control group presented a REC = −0.59 ± 0.80 mm with PH = −1.12 ± 0.55 mm, demonstrating a slight continuous soft tissue shrinkage during the entire follow‐up. The mean values were statistically significant different between test and control group for both REC gain ( P = 0.01174) and PH ( P = 0.0009). Conclusions With the limitations of this study, immediate single implant restorations rehabilitated with platform‐switching protocol may provide peri‐implant alveolar bone‐level stability and avoid continuous soft tissue shrinkage after 10 years of prosthetic loading compared to a platform‐matching restoration. Further studies involving larger sample sizes are required to confirm these preliminary results.