Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
ID06516263

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

Led by Dublin Dental University Hospital · Updated on 2024-07-23

50

Participants Needed

1

Research Sites

13 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research investigates the impact of Leukocyte and Platelet Rich Fibrin (L-PRF) on the stability of dental implants and the levels of bone surrounding them. The study compares the use of L-PRF during implant placement to traditional implant placement methods. L-PRF is a fibrin mesh rich in growth factors that may improve healing, bone growth, and implant integration, but high-quality evidence in humans, especially in the jawbone, is limited. This trial aims to provide clearer clinical evidence to help dentists decide whether to use L-PRF for better implant stability and earlier implant loading. Participants will be randomly assigned to one of two groups: one receiving standard implant placement with L-PRF applied to the implant site, and the other receiving standard implant placement without L-PRF. L-PRF is prepared by centrifuging the participant's blood to form a fibrin clot, which is then placed around the implant during surgery. This additional step aims to enhance bone healing and implant integration. The study will take place at the Dublin Dental University Hospital and include implants placed in both the upper (maxilla) and lower (mandible) jaws. Participants will be monitored over several months with evaluations at baseline, 3 months, and between 4 to 6 months after implant placement. Assessments include measuring implant stability using an implant stability quotient, as well as clinical and radiographic evaluations of bone levels around the implant. Pain levels will also be recorded shortly after surgery and during the first week. Participants will maintain a symptom diary and attend scheduled appointments to monitor progress and safety throughout the study period, which extends until September 2026.

CONDITIONS

Brief Title

Effect of L-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 aged 18 years or older
  • Capacity to provide informed consent
  • Willing to comply with study appointments and maintain a symptom diary
  • Planned dental implant placement at Dublin Dental University Hospital
  • Implant site in maxilla or mandible
  • Sufficient bone volume for implant placement without bone grafting (minimum 6mm width for 4mm diameter implants, minimum 7mm width for 5mm diameter 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 expected to impact bone healing (e.g., bisphosphonates)
  • Pregnancy or lactation
  • Lack of capacity to give informed consent
  • Previous radiation to head and/or neck
  • Insufficient bone volume requiring bone graft or augmentation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Single day procedure with follow-up visits up to 6 months

Participants receive dental implant placement either with Leukocyte and platelet rich fibrin or standard implant placement without it.

1 implant placement visit and follow-up visits at baseline, 3 months, and 4 to 6 months

Follow-up

Duration - Up to 6 months after implant placement

Participants are monitored for implant stability, pain, and marginal bone levels after implant placement.

Visits after anaesthetic wears off, at 24 hours, 1 week, 3 months, and 4 to 6 months post-implant placement

Trial Site Locations

Total: 1 location

1

Dublin Dental University Hospital

Dublin, Ireland, D02F859

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Research Team

D

Daniel Merrick, BDent Sc

I

Ioannis Polyzois, FFD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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