A clinical and radiographic study of implants placed in autogenous bone grafts covered by either a platelet-rich fibrin membrane or deproteinised bovine bone mineral and a collagen membrane: a pilot randomised controlled clinical trial with a 2-year follow-up

一项关于自体骨移植中植入物在覆盖有富血小板纤维蛋白膜或脱蛋白牛骨矿物质和胶原蛋白膜的情况下的临床和放射学研究:一项为期2年的随机对照临床试验

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Abstract

PURPOSE: To compare the survival and clinical performance of implants placed in sites previously augmented with autogenous bone grafts covered by either a platelet-rich fibrin (PRF) membrane (PRF group) or a standard procedure (gold standard) involving coverage of the autogenous bone graft with deproteinised bovine bone mineral and a resorbable collagen membrane (control group). METHODS: A total of 27 partially edentulous patients (test n = 14, control n = 13) with indication for staged lateral bone block augmentation and dental implant placement were included. Twenty-four months after crown placement (range: 14-32 months), patients were recalled for a final clinical and radiographic follow-up. Outcome measures were implant survival, implant crown survival, clinical parameters of the implant, peri-implant marginal bone level, marginal bone level of adjacent tooth surfaces, biological and technical complications and patient-related outcome measures. RESULTS: Two implants were lost in the control group (85% survival rate); none were lost in the PRF group (100% survival rate). None of the 26 initially placed implant crowns were lost, but one implant and therefore one implant crown were lost after 20 months. Consequently, the definitive implant crown survival was 92% (95% confidence interval (CI): 73-110%) in the control group and 100% in the PRF group. No statistical difference in implant survival rate (p = 0.13) or implant crown survival was seen between the groups (p = 0.28). The mean marginal bone level at the follow-up was 0.26 mm (95% CI: 0.01-0.50 mm) in the PRF group and 0.68 mm (95% CI: 0.41-0.96 mm) in the control group. The difference between the groups was - 0.43 mm (95% CI: - 0.80 to - 0.05 mm, p = 0.03), which was statistically significant (p = 0.03). Both groups demonstrated similar healthy peri-implant soft tissue values at the final follow-up. CONCLUSION: Although the current study is based on a small sample of participants, the findings suggest that the methodology of the PRF and the control group approach can both be used for bone augmentation with a similar outcome. A significant, but clinically irrelevant, higher peri-implant marginal bone level was registered in the PRF group than in the control group. Patients in both groups were highly satisfied with the treatment. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04350749 . Registered 17 April 2020. Retrospectively registered.

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