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.

Conditions

• Osseointegration Failure of Dental Implant

Interventions

BIOLOGICAL

Horizontal platelet-rich fibrin (H-PRF)

Most 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.

Sponsors & Collaborators

• University of Dublin, Trinity College

  lead OTHER

Principal Investigators

• Dr Ioannis Polyzois, Consultant · Dublin Dental University Hospital

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-05-17

Primary Completion

2026-06-01

Completion

2026-09-01

Countries

• Ireland

Study Locations