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.
Male or Female, 18 years old or over
Capacity to provide informed consent
Willing to comply with study appointment schedule and willing to maintain a diary of symptoms
Planned for provision of dental implant(s) at Dublin Dental University Hospital Site Level
Plaque score >20%
Bleeding score >20%
Tobacco smoking
Uncontrolled systemic disease
Parallel
Horizontal platelet-rich fibrin (H-PRF)
Biological/VaccineMost commercially available centrifuges used for PRF production are fixed-angle systems designed primarily for pelleting samples to the bottom of tubes and are not particularly efficient at separating the cell layers effectively. Research has demonstrated that PRF produced using horizontal centrifugation (H-PRF) can lead to a higher concentration of platelets and leukocytes compared to PRF produced from fixed-angle centrifugation (LPRF). The resulting PRF from horizontal centrifugation is termed 'horizontal platelet-rich fibrin' (H-PRF). The H-PRF clot will be produced using a Bio-PRF horizontal centrifuge machine. This machine is CE marked and regularly used in the Dublin Dental University Hospital.
Primary outcome: Implant Stability Quotient (ISQ) using magnetic resonance frequency analysis (MRFA)
This is a measurement of the stability of the implant
Secondary outcomes: Marginal bone levels
The level of bone around the implant
Rate of pain experienced based on a visual analog scale 1-10
Rate of pain experienced using a survey that will be given to patients. They will be given a visual analog scale and asked to use that to rate their pain.
Number of participants with implant loss/fracture/infection
Any implant failures/infections. This includes loss of implant, fracture of the implant or infection of the implant site.
Click on the lead sponsor to view all of their trials.
