Osseointegration Failure of Dental Implant Clinical Trial
Official title:
A Randomised Control Clinical Trial Investigating the Effect of Horizontal-Platelet-Rich Fibrin (H-PRF) vs Standard Placement on Implant Stability and Marginal Bone Levels in Adults
NCT number | NCT06453330 |
Other study ID # | 3470 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | May 17, 2024 |
Est. completion date | September 1, 2026 |
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.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | September 1, 2026 |
Est. primary completion date | June 1, 2026 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 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) 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 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 |
Country | Name | City | State |
---|---|---|---|
Ireland | Dublin Dental University Hospital | Dublin |
Lead Sponsor | Collaborator |
---|---|
University of Dublin, Trinity College |
Ireland,
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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. — View Citation
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. — View Citation
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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. — View Citation
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Secondary outcomes: Marginal bone levels | The level of bone around the implant | At implant placement, at 3 months and at 4-5 months (implant restoration) | |
Secondary | 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. | after local anaesthetic wears away, 24 hours after implant placement and 1 week after implant placement | |
Secondary | 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. | At any point from implant placement until 4-5 months afterwards |
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