Effect of L-PRF on Implant Stability and Marginal Bone Levels.

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

Osseointegration refers to the formation of a structure and functional bone-to-bone interface, without the interposition of soft tissue. Successful osseointegration is imperative to implant success and relies on a number of factors including implant design, material, surface and finish the bone status, surgical technique and implant loading conditions. Primary implant stability is the bio-mechanical stability achieved for implants at the time of placement and is achieved through micromovements of the implant. Following healing of the osteotomy site and formation of new bone a biological fixation of the implant to bone results and is referred to as secondary implant stability. Such as with osseointegration, there are several factors that affect primary implant stability including insertion torque, implant design, density of bone and surgical technique. To achieve future implant osseointegration, primary stability must first be accomplished.

Leukocyte and platelet rich fibrin (L-PRF) is formed by centrifuging venous blood using an IntraSpin® machine (U.S Food and Drug Administration approved and CE marked for in-vivo use) at 2700 revolutions per minute for 12 minutes. Following removal from the L-PRF tubes the fibrin clot is separated from the red blood cell clot. The fibrin clot is then transferred to the PRF box and the Xpression™ tray is placed over the fibrin clot and after 5 minutes the L-PRF membrane is ready for use.

During the traditional implant placement there is an osteotomy cut in practical terms is a controlled fracture of the bone resulting in rupture of local blood vessels which almost immediately sparks a cascade of healing including hemostasis, inflammation and proliferation of cells and tissue maturation. Our study will include Leukocyte platelet rich fibrin surrounding the implant at the osteotomy site which is a robust fibrin mesh which provides a progressive release of growth factors improving angiogenesis, osteoblastic proliferation, and cell differentiation. L-PRF utilization during implant placement attempts to expedite the process by delivering growth factors to the surface of the implant and surrounding bone promoting the healing process. Experimental research has shown that delivery of molecules or growth factors to an implants surface may increase osteoblast activity and improve functional integration of the implant.

Pre-clinical tests have shown that the utilization of platelet growth factors improve wound healing, proliferation of cells and implant osseointegration in animal models. Further pre-clinical studies have shown that L-PRF increased the rate and amount of new bone formation in rabbits.

Limited human tests in small populations not including the mandible have shown positive outcomes with improvement in implant stability when L-PRF was utilized during implant placement. High quality clinical evidence on this topic is limited and must be improved to allow clinicians to make evidence-based decisions on L-PRF utilization.

The proposed study will be a randomized control trial comparing the use of L-PRF in implant placement versus conventional implant placement. Considering the extra step of phlebotomy and time for centrifuging of the blood samples the literature must show a clinical benefit if this technique is to be utilized into the future. This study aims to add to available clinical evidence and address some of the limitations in current evidence to aid clinicians to make evidence-based decisions on whether to utilize LPRF to improve implant stability and hence earlier loading of implants.

Study Overview

• Status: Recruiting
• Conditions: Dental Implant; Implant Stability; L-PRF; Marginal Bone Levels
• Intervention / Treatment: Procedure: Leukocyte and platelet rich fibrin; Procedure: Standard implant placement

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Daniel Merrick, BDent Sc; Phone Number: 00353877410480; Email: merrickd@tcd.ie
• Study Contact Backup: Name: Ioannis Polyzois, FFD; Phone Number: 0035301 6127237; Email: Ioannis.Polyzois@dental.tcd.ie

Study Locations

• Ireland
  • Dublin, Ireland, D02F859
    • Recruiting
    • Dublin Dental University Hospital
    • Contact: Daniel Merrick, BDent Sc; Phone Number: 00353877410480; Email: merrickd@tcd.ie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Inclusion Criteria:

Patient Level

• Male or Female, 18 years old or over
• Capacity to provide informed consent
• Willing to comply with study appointment schedule Willing to maintain a diary of symptoms
• Planned for provision of dental implant(s) at Dublin Dental University Hospital Site Level
• Location: maxilla and mandible
• 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)

Exclusion Criteria:

• 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 of capacity to give informed consent
• Previous radiation to the head and/or neck Site Level
• Insufficient bone volume for implant placement, requiring bone graft/augmentation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: The effect of Leukocyte and platelet rich fibrin on Implant Stability and Marginal Bone Levels.; Standard Implant placement with Leukocyte and platelet rich fibrin	Procedure: Leukocyte and platelet rich fibrin; Formation of an Leukocyte and platelet rich fibrin clot and placement into the osteotomy site prior to implant placement
Placebo Comparator: The Effect of standard implant placement on implant Stability and Marginal Bone Levels.; standard implant placement	Procedure: Standard implant placement; Standard implant placement without Leukocyte and platelet rich fibrin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implant stability quotient	taken as Implant stability quotient value with an OSTELL device	baseline, 3 months and 4-6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain levels	Pain levels recorded on Visual Analogue Scale	After anaesthetic has worn off, 24 hours and 1 week
Clinical Marginal bone levels	measure of implant to crest of bone	Measured clinically at baseline and 3 months after implant placement at second stage surgery
Radiographic marginal bone levels	measurement of crest of bone to implant on radiograph	at baseline 3 months and 4-6 months following implant placement

Collaborators and Investigators

• Sponsor: Dublin Dental University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: July 12, 2024
• First Submitted That Met QC Criteria: July 18, 2024
• First Posted (Actual): July 23, 2024

Study Record Updates

• Last Update Posted (Actual): July 23, 2024
• Last Update Submitted That Met QC Criteria: July 18, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: DublinDental

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

During collection the pseudo anonymized/coded data will be saved separately from the patients' dental charts on a password protected Dublin Dental University Hospital (DDUH) computer. The information will remain confidential from other DDUH health care staff, who can view patients' records.

b) Following collection of the data, they will be processed to become anonymous (The identification key will be deleted). All anonymized data will be stored on a password protected DDUH computer with access granted only to the investigator and supervisor.

c) It is not anticipated that there will be any hardcopy records arising from this study d) All data will be securely retained for 5 years after their analysis according to best practice regulations. - Five years after their original analysis, all data will be destroyed. All electronic data will be permanently deleted.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No