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

NCT06516263 | Recruiting

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

Brief Summary

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.

Conditions

Dental Implant; Implant Stability; Marginal Bone Levels; L-PRF

Outcome Measures

Primary Outcomes (1)

• Implant stability quotient

  taken as Implant stability quotient value with an OSTELL device

  baseline, 3 months and 4-6 months

Secondary Outcomes (3)

• Pain levels

  After anaesthetic has worn off, 24 hours and 1 week

• Clinical Marginal bone levels

  Measured clinically at baseline and 3 months after implant placement at second stage surgery

• Radiographic marginal bone levels

  at baseline 3 months and 4-6 months following implant placement

Study Arms (2)

The effect of Leukocyte and platelet rich fibrin on Implant Stability and Marginal Bone Levels.

EXPERIMENTAL

Standard Implant placement with Leukocyte and platelet rich fibrin

Procedure: Leukocyte and platelet rich fibrin

The Effect of standard implant placement on implant Stability and Marginal Bone Levels.

PLACEBO COMPARATOR

standard implant placement

Procedure: Standard implant placement

Interventions

Leukocyte and platelet rich fibrin PROCEDURE

Formation of an Leukocyte and platelet rich fibrin clot and placement into the osteotomy site prior to implant placement

The effect of Leukocyte and platelet rich fibrin on Implant Stability and Marginal Bone Levels.

Standard implant placement PROCEDURE

Standard implant placement without Leukocyte and platelet rich fibrin

The Effect of standard implant placement on implant Stability and Marginal Bone Levels.

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 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)

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 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

Sponsors & Collaborators

• Dublin Dental University Hospital: lead

Study Sites (1)

Dublin Dental University Hospital

Dublin, D02F859, Ireland

RECRUITING

MeSH Terms

Interventions

Leukocyte Count

Intervention Hierarchy (Ancestors)

Blood Cell Count; Cell Count; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Hematologic Tests; Investigative Techniques; Cell Physiological Phenomena; Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Central Study Contacts

Daniel Merrick, BDent Sc

CONTACT

00353877410480; merrickd@tcd.ie

Ioannis Polyzois, FFD

CONTACT

0035301 6127237; Ioannis.Polyzois@dental.tcd.ie

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This is a parallel arm, randomised control clinical Trial (RCT) on a cohort of Dublin Dental University Hospital patients who are having dental implants placed.

Study Record Dates

• First Submitted: July 12, 2024
• First Posted: July 23, 2024
• Study Start: June 1, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: July 23, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)