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New treatment option for Osseointegration Failure of Dental Implant
Official title A Randomised Control Clinical Trial Investigating the Effect of H-PRF on Implant Stability and Marginal Bone Levels
ClinicalTrials.gov ID: NCT06453330
What this study is testing
What is Horizontal platelet-rich fibrin (H-PRF)?
Horizontal platelet-rich fibrin (H-PRF) is an investigational medicine, given as a treatment applied to the skin, being studied as a potential treatment for osseointegration failure of dental implant.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join 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
You likely can't join 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)
See the full eligibility 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Dublin, Ireland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Dublin, Ireland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.