Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
ID06453330

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

Led by University of Dublin, Trinity College · Updated on 2024-06-11

50

Participants Needed

1

Research Sites

13 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the effect of Horizontal Platelet Rich Fibrin (H-PRF) on the stability and bone levels of dental implants in adults. This randomized controlled clinical trial focuses on patients receiving dental implants in the upper or lower jaws at Dublin Dental University Hospital. H-PRF is a biologic material derived from patients' blood that may encourage bone growth and implant integration, and this study aims to compare implants placed with and without H-PRF to assess its potential benefits. Participants will be randomly assigned to one of two groups: one where implants are coated with H-PRF and another where implants are placed without H-PRF. The H-PRF is prepared by drawing blood from patients, then processing it in a horizontal centrifuge to create a clot used during implant placement. Implants will be placed using standard surgical protocols, and the procedure will be identical for both groups aside from the use of H-PRF. During the study, participants will have implant stability and bone levels measured at implant placement, three months later, and at the time of implant restoration (around 4 to 5 months). Pain levels will be recorded at various points after surgery, and the occurrence of implant loss, fracture, or infection will be monitored. Patients will also maintain symptom diaries and attend scheduled study visits. The study will last several months, with careful monitoring to evaluate the impact of H-PRF on dental implant success.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or Female, 18 years old or over
  • Ability to provide informed consent
  • Willingness to comply with study appointments and maintain a symptom diary
  • Planned dental implant placement at Dublin Dental University Hospital
  • Sufficient bone volume for implant placement without bone graft or augmentation; minimum alveolar ridge width of 6mm for standard implants and 7mm for wider implants
Not Eligible

You will not qualify if you...

  • Plaque score greater than 20%
  • Bleeding score greater than 20%
  • Tobacco smoking
  • Uncontrolled systemic disease
  • Use of systemic medications that affect bone healing (e.g., bisphosphonates)
  • Pregnancy or breastfeeding
  • Inability to provide informed consent
  • History of radiotherapy to the head or neck
  • Insufficient bone volume requiring bone graft or augmentation for implant placement

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - At least 7 days

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) for dental implant assessment

Treatment

Duration - Single day for implant placement

Participants receive standard dental implant placement with or without horizontal platelet-rich fibrin (H-PRF) depending on randomization. Blood samples are taken for H-PRF preparation for those in the treatment group.

1 visit for implant placement

Post-operative Follow-up

Duration - Up to 4 to 5 months after implant placement

Participants are monitored for implant stability, marginal bone levels, pain, and any implant complications over several months following implant placement.

Visits at implant placement, 24 hours post-placement, 1 week, 3 months, and 4 to 5 months for implant restoration

Trial Site Locations

Total: 1 location

1

Dublin Dental University Hospital

Dublin, Ireland, D02 F859

Actively Recruiting

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Research Team

R

Rawan Kahatab, BDS

D

Dr Ioannis Polyzois, Consultant

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

Frequently Asked Questions

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Published Research Related To This Trial

Does platelet-rich fibrin increase the stability of implants in the posterior of the maxilla? A split-mouth randomized clinical trial.

R Tabrizi, H Arabion, T Karagah

https://pubmed.ncbi.nlm.nih.gov/29269149

A novel method for evaluating and quantifying cell types in platelet rich fibrin and an introduction to horizontal centrifugation.

Richard J Miron, Jihua Chai, Shihang Zheng...

https://pubmed.ncbi.nlm.nih.gov/31148358

Histological comparison of Platelet rich fibrin clots prepared by fixed-angle versus horizontal centrifugation.

Masako Fujioka-Kobayashi, Michihide Kono, Hiroki Katagiri...

https://pubmed.ncbi.nlm.nih.gov/32306811