The Clinical and Biological Effects of Leucocyte and Platelet-rich Fibrin (L-PRF) on Post-extraction Sockets Healing

January 9, 2022 updated by: Maurizio Tonetti, The European Research Group on Periodontology (ERGOPerio)

The Clinical and Biological Effects of Leucocyte and Platelet-rich Fibrin (L-PRF) on Post-extraction Sockets Healing: a Randomized Controlled Trial

This study evaluates the clinical and biological effects of leucocyte and platelet-rich fibrin (L-PRF) on post-extraction sockets healing.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Tooth extraction is one of the most frequent dental surgical procedures. Following tooth extraction, dimensional changes of the alveolus are inevitable, which consequently decrease the height and width of alveolar bone and impair ideal implant placement and conventional prosthetic treatment. In order to reduce the bone resorption after tooth extraction, the use of platelet concentrates has been proposed. Platelet rich fibrin (PRF) is a second generation of platelet concentrates consisting of platelets, leukocyte and growth factors harvested from blood. PRF not only supports hemostasis but also favors the natural wound healing process. Over the past decade, PRF has gained tremendous momentum having been utilized for a variety of dental and medical procedures including the management of post-extraction sockets. To date, several studies have assessed the efficacy of the use of PRF in promoting postextraction sockets healing. However, results remain contradictory and mainly focus on the clinical and radiological hard and soft tissue healing, aesthetics and postoperative discomfort. The mechanistic hypothesis is that growth factors released by PRF preparations modulate the wound healing process but the effect of local PRF application on the kinetics of release of wound healing modulators has not been studied so far. There is also a lack of information in the literature regarding the biological evaluation during postextraction sockets healing to understand the potential mechanisms. In order to assess the presence or follow dynamics of biomarkers, in this study wound fluid (WF) will be collected from the post-extraction sockets and utilized for multiplex immunoassay. Multiplex immunoassay allows simultaneous quantification of multiple markers providing unique information for a more complete understanding of the potential mechanism of PRF and spontaneous extraction socket healing. Therefore, the aim of this randomized clinical trial is to evaluate the effects of PRF on biomarkers response during post-extraction sockets healing.

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Faculty of Dentistry, The University of Hong Kong

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Participant is willing and able to give informed consent for participation in the study
  • Healthy males and females of age 18-70
  • Need for two or more extractions of single rooted teeth in the presence of adjacent teeth or implants due to unrestorable caries, residual roots, root fractures or orthodontic treatment
  • Able (in the investigators opinion) and willing to comply with all study requirements
  • Interested in tooth replacement with dental implants

Exclusion Criteria:

  • Endodontic periapical lesions with a diameter of more than 5 mm (radiographically determined)
  • Sites with buccal and lingual bone plate loss more than 5 mm
  • Frank purulence or acute abscess at the time of extraction
  • Pregnancy or lactation
  • Smokers or alcoholics
  • Platelet dysfunction syndrome or thrombocytopenia
  • Uncontrolled diabetes
  • Medical contraindications to elective oral surgery procedures

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: L-PRF
Post-extraction sockets will be filled with autologous leucocyte and platelet-rich fibrin (L-PRF) clot.
Other: leucocyte and platelet-rich fibrin (L-PRF)
The blood collected from each patient will be centrifuged immediately at 2700 rpm for 12 min to separate L-PRF.
No Intervention: Control
Post-extraction sockets will be left to heal spontaneously with natural blood clot.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Concentrations changes of the molecules and inflammatory mediators
Time Frame: Baseline, 6 hours, 24 hours, 3 days and 7 days
Concentrations changes of the molecules and inflammatory mediators in the gingival crevicular fluid (GCF) or wound fluid (WF) from the extraction sockets in L-PRF group and control group at baseline (from GCF), 6 hours, 24 hours, 3 days, 7 days.
Baseline, 6 hours, 24 hours, 3 days and 7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Genes expression profiles
Time Frame: Baseline and 3 days
Genes expression profiles of the growth and differentiation factors and inflammatory mediators from the tissue specimen taken from the post-extraction sockets at 3 days.
Baseline and 3 days
Laser Doppler Flowmetry (LDF) measurement
Time Frame: Before and immediately after the tooth extraction, 6 hours, 24 hours, 3 days and 7 days
A commercially available Laser Doppler Blood FlowMeter equipped with a standard fiber optic probe will be used for LDF measurements before tooth extraction, immediately postoperatively, 6 hours, 24 hours, 3 days and 7 days.
Before and immediately after the tooth extraction, 6 hours, 24 hours, 3 days and 7 days
Radiographic bone changes (Cone-beam computed tomography)
Time Frame: Baseline and 4 months
Cone-beam computed tomography (CBCT) images will be obtained before extraction as the baseline and at the 4 months.
Baseline and 4 months
Wound Healing Index (HI)
Time Frame: 6 hours, 24 hours, 3 days and 7 days
Soft tissue healing will be assessed by Wound Healing Index (1 = very poor, 2 = poor, 3 = good, 4 = very good, 5 = excellent).
6 hours, 24 hours, 3 days and 7 days
Visual analog scale (VAS)
Time Frame: 6 hours, 24 hours, 3 days and 7 days
A 10-point VAS with a score of 0 that equals "no pain" and a score of 10 that equals "worst pain imaginable" will be used to evaluate the postoperative pain at 6 hours, 24 hours, 3 days and 7 days. The patients will be asked to fill the pain they feel at the time of questioning. Questionnaires will be collected at the one-week follow-up visit.
6 hours, 24 hours, 3 days and 7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The European Research Group on Periodontology (ERGOPerio)

Collaborators

The University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2019

Primary Completion (Actual)

December 31, 2021

Study Completion (Actual)

December 31, 2021

Study Registration Dates

First Submitted

June 10, 2019

First Submitted That Met QC Criteria

June 12, 2019

First Posted (Actual)

June 13, 2019

Study Record Updates

Last Update Posted (Actual)

January 11, 2022

Last Update Submitted That Met QC Criteria

January 9, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • HKUPhD20190528

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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