A Randomised Control Clinical Trial Investigating the Effect of H-PRF on Implant Stability and Marginal Bone Levels

Summary

This research will be a randomised controlled trial (RCT) investigating whether the use of Horizontal Platelet Rich Fibrin (H-PRF) increases implant stability compared to those implants placed without H-PRF, and therefore, contributes to the implant's overall success. H-PRF is a second generation platelet concentrate that consists of a fibrin mesh containing cytokines and leukocytes. It has been shown to stimulate mesenchymal stem cells and osteoblasts that encourage bone formation as a result of the growth factors released from platelets, which should aid in osseointegration of implants. There is limited research that investigates the effects of H-PRF on implant stability. There is, however, some evidence that platelet-rich fibrin (PRF), which is produced in a fixed-angle centrifuge, increases implant stability and H-PRF is considered the evolution of PRF products. This research would follow a H-PRF preparation protocol which involves taking a sample of venous blood from patients using a butterfly needle to collect up to 8-9ml tubes of blood. After the tube of blood is collected, it would immediately be placed in a horizontal centrifuge machine with 3 tubes of water to balance the centrifuge, and placed opposite each other. A set rpm and time will be chosen, and the centrifuge will run until the time is complete. The H-PRF clots would then be ready and taken out of the tubes to separate them from the red blood cells. Following randomisation, implants will be placed in the upper or lower jaws of patients attending the Dublin Dental University Hospital using the standard implant protocol. Half of the implants will be coated with H-PRF, the other half (control group) would be placed without HPRF. Implant stability and marginal bone levels will be measured at three different stages: 1) Initial implant placement, 2) Second stage surgery when the implant is uncovered after healing and integrated with the bone, 3) When the definitive crown or bridge is attached to the implant. Insertion torque at baseline will also be measured. The above results will be collected and assessed to determine the effects of H-PRF, if any, on implant stability and the preservation of bone levels around implants.

Timeline

Start

2024-05-17

Primary completion

2026-06-01

Completion

2026-09-01

Publications

• Background Tabrizi R, Arabion H, Karagah T. Does platelet-rich fibrin increase the stability of implants in the posterior of the maxilla? A split-mouth randomized clinical trial. Int J Oral Maxillofac Surg. 2018 May;47(5):672-675. doi: 10.1016/j.ijom.2017.07.025. Epub 2017 Dec 18.
• Background Oncu E, Alaaddinoglu EE. The effect of platelet-rich fibrin on implant stability. Int J Oral Maxillofac Implants. 2015 May-Jun;30(3):578-82. doi: 10.11607/jomi.3897.
• Background Miron RJ, Chai J, Zheng S, Feng M, Sculean A, Zhang Y. A novel method for evaluating and quantifying cell types in platelet rich fibrin and an introduction to horizontal centrifugation. J Biomed Mater Res A. 2019 Oct;107(10):2257-2271. doi: 10.1002/jbm.a.36734. Epub 2019 Jun 12.
• Background Lucarelli E, Beccheroni A, Donati D, Sangiorgi L, Cenacchi A, Del Vento AM, Meotti C, Bertoja AZ, Giardino R, Fornasari PM, Mercuri M, Picci P. Platelet-derived growth factors enhance proliferation of human stromal stem cells. Biomaterials. 2003 Aug;24(18):3095-100. doi: 10.1016/s0142-9612(03)00114-5.
• Background Uggeri J, Belletti S, Guizzardi S, Poli T, Cantarelli S, Scandroglio R, Gatti R. Dose-dependent effects of platelet gel releasate on activities of human osteoblasts. J Periodontol. 2007 Oct;78(10):1985-91. doi: 10.1902/jop.2007.070116.
• Background Anitua EA. Enhancement of osseointegration by generating a dynamic implant surface. J Oral Implantol. 2006;32(2):72-6. doi: 10.1563/736.1.
• Background Fujioka-Kobayashi M, Kono M, Katagiri H, Schaller B, Zhang Y, Sculean A, Miron RJ. Histological comparison of Platelet rich fibrin clots prepared by fixed-angle versus horizontal centrifugation. Platelets. 2021 Apr 3;32(3):413-419. doi: 10.1080/09537104.2020.1754382. Epub 2020 Apr 18.

Drugs

Indications

No indication recorded.