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

NCT06453330 | Recruiting

• 1 other identifier: 3470
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Primary outcome: Implant Stability Quotient (ISQ) using magnetic resonance frequency analysis (MRFA)

  This is a measurement of the stability of the implant

  At implant placement, at 3 months and at 4-5 months (implant restoration)

Secondary Outcomes (3)

• Secondary outcomes: Marginal bone levels

  At implant placement, at 3 months and at 4-5 months (implant restoration)

• Rate of pain experienced based on a visual analog scale 1-10

  after local anaesthetic wears away, 24 hours after implant placement and 1 week after implant placement

• Number of participants with implant loss/fracture/infection

  At any point from implant placement until 4-5 months afterwards

Study Arms (2)

An intervention group receiving standard placement of single implants with H-PRF

EXPERIMENTAL

H-PRF preparation protocol involves taking a sample of venous blood from patients using a butterfly needle to collect up to 8-9ml tubes of blood. After the first tube is collected, it would immediately be placed in a horizontal centrifuge machine, balanced out with 3 tubes of water, to ensure the centrifuge is properly balanced. 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.

Biological: Horizontal platelet-rich fibrin (H-PRF)

A control group receiving standard placement of single implants without H-PRF

NO INTERVENTION

this group will have standard implant placement without H-PRF

Interventions

Horizontal platelet-rich fibrin (H-PRF) BIOLOGICAL

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.

An intervention group receiving standard placement of single implants with H-PRF

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient Level
• 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
• Sufficient bone volume for implant placement without the need for bone graft/augmentation; alveolar ridge of minimum 6mm width for standard implants (implant diameter 4mm) and of minimum 7mm for wider implants (implant diameter 5mm)

You may not qualify if:

• Patient Level
• Plaque score \>20%
• Bleeding score \>20%
• Tobacco smoking
• Uncontrolled systemic disease
• Use of systemic medications with an expected impact on bone healing (e.g. bisphosphonates)
• Pregnancy or lactation
• Lack capacity to give informed consent
• History of radiotherapy to the head and/or neck Site Level
• Insufficient bone volume for implant placement, requiring bone graft/augmentation

Sponsors & Collaborators

• University of Dublin, Trinity College: lead

Study Sites (1)

Dublin Dental University Hospital

Dublin, D02 F859, Ireland

RECRUITING

Related Publications (7)

• 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.

  PMID: 29269149 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.

  PMID: 26009908 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.

  PMID: 31148358 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.

  PMID: 12895582 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.

  PMID: 18062120 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.

  PMID: 16704108 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.

  PMID: 32306811 BACKGROUND

Study Officials

• Dr Ioannis Polyzois, Consultant

  Dublin Dental University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rawan Kahatab, BDS

CONTACT

00353871679359; kahatabr@tcd.ie

Dr Ioannis Polyzois, Consultant

CONTACT

01 6127391; ioannis.polyzois@dental.tcd.ie

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Due to the nature of having to draw blood from participants who will be receiving H-PRF, nobody can be masked/blinded
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postgraduate periodontology student

Model Details: An intervention group receiving standard placement of single implants with H-PRF and a control group receiving standard placement of single implants without H-PRF

Study Record Dates

• First Submitted: June 5, 2024
• First Posted: June 11, 2024
• Study Start: May 17, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: June 11, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)