The Evolution of Extended Platelet-Rich Fibrin Membranes for Socket Grafting: Part Two: A Randomized Clinical Trial Comparing These Membranes with Collagen Membranes.
Abstract
Background: Extended platelet-rich fibrin (e-PRF) membranes are a novel 100% autologous biomaterial with a longer resorption time (4-6 months) than traditional solid-PRF membranes (two weeks). In part 1 of this 2-part publication series, four clinical variations for using these novel e-PRF membranes for socket preservation were introduced. In this randomized clinical trial (RCT), all four iterations of e-PRF membranes were compared to traditional collagen membranes in alveolar ridge preservation for hard and soft tissue dimensional changes and early wound healing outcomes. Methods: A single-center RCT was conducted, including 55 patients requiring the extraction of a single tooth with planned implant placement. All sockets were grafted with a "sticky bone" (bone allograft mixed with PRF) and secured with either a collagen membrane (control) or e-PRF membranes utilizing the four variations present in Part 1 (both formed extra-orally or intra-orally, each with or without an overlying solid PRF membrane). The time of fabrication and application of each e-PRF iteration was recorded. Cone beam computed tomography was utilized to evaluate horizontal and vertical ridge dimensions at baseline and 3 months post-operatively, and soft tissue thickness was also measured at both time intervals utilizing an endodontic reamer. Early wound healing was recorded at 2 weeks, utilizing the Landry, Turnbull, and Howley Index by three blinded clinicians. Results: The results demonstrated that, at 3 months, the e-PRF membranes fabricated utilizing all 4 treatment variations demonstrated equal improvements in horizontal and vertical ridge dimensions and soft tissue thickness when compared to collagen membranes. Additionally, the membrane (p = 0.029) and membrane w/solid (p = 0.021) groups demonstrated statistically significant superior early wound healing compared to the collagen membrane group. Notably, the Bio-Filler groups demonstrated statistically significant reduction in fabrication/application time compared to the membrane groups. Conclusions: Within the limitations of this RCT, all e-PRF iterations performed comparably to collagen membranes in maintaining both hard and soft tissue ridge dimensions when combined with sticky bone, while also significantly improving soft tissue wound healing. Future RCTs with alternative grafting materials, direct wound-margin assessment, and evaluation of patient-reported outcomes are necessary to clarify the advantages of each membrane type.