Mechanisms of LPRF Action in the Promotion of Wound Healing and Tissue Regeneration

February 13, 2023 updated by: Maurizio Tonetti, The European Research Group on Periodontology (ERGOPerio)

Mechanisms of LPRF Action in the Promotion of Wound Healing and Tissue Regeneration: A Randomised Controlled Trial

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Gingival recession is characterized by the exposure of root surfaces of the tooth, is attributed to the apical migration of the gingival marginal tissue, and it is a frequently noted clinical feature in all populations. Other than cosmetic problems, a gingival recession can have a causative role in tooth sensitivity, and contribute to difficulties in oral hygiene maintenance or root caries. Moreover, it may worsen with time.

The ultimate goal of surgical root-coverage procedures (Periodontal plastic surgery) is the elimination of the recession defect with minimal probing depths after treatment, along with the ability to restore the natural color and texture of the gingiva (gum). By achieving root coverage, overall improved aesthetics, prevention of non-carious cervical lesions or root caries, and treatment of the resulting root sensitivity should be expected.

Surgical interventions in general, and in particular those aiming to reconstruct tissues lost due to trauma or disease in particular, are biologically dependent on a cascade of unimpaired wound healing mechanisms, including a non-disrupted inflammatory process, vascularization(blood supply) of the wound area, and consequent tissue regeneration. Wound healing has been defined as "the natural response to injury compiling a cascade of complex events orchestrated in a way that many cell types guided by the release of soluble mediators and signals. In a bid to enhance this phase, autologous platelet 'concentrates' were developed, derived from centrifuged blood of patients and applied as surgical adjuncts. Previous studies indicate that leucocyte plasma rich fibrin (LPRF/newest generation of platelet concentrates) preparations significantly modulate wound healing and promote tissue regeneration in a variety of oral surgical procedures. Clinical studies where LPRF is analyzed at the molecular level to quantify the temporal release of growth factors, cytokines, or other biomolecular components are still lacking. Despite the broad application of LPRF in modern dentistry information which integrates clinical and molecular data from in vivo models are essential to elucidate its relevant biological mechanisms. The mechanisms of action are unclear, and the relative role of their different components have not been fully explained. This study will aim to investigate if LPRF can offer superior clinical outcomes and will compare the concentrations and kinetics of wound healing regulators in root coverage procedures with and without local application of LPRF.

Study Type

Interventional

Enrollment (Actual)

12

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

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 18-70
  • Non-smokers or former smokers
  • Participants must agree to read the "Patient information leaflet and provide a signed a copy of the "Informed Consent", after the study design has been completely explained.
  • Presence of bilateral isolated Miller Class I and II gingival recessions in anterior and premolar regions.
  • Presence of minimum 2 mm of keratinized gingiva apical to the gingival margin at the selected sites.

Exclusion Criteria:

  • The patient is medically compromised with history of diabetes mellitus or hepatic or renal disease, or other serious medical conditions or transmittable diseases e.g. Hepatitis B or C or AIDS.
  • History of rheumatic fever, heart murmur, mitral valve prolapse, artificial heart valve or conditions which would require antibiotic prophylaxis invasive dental procedures.
  • Patients undergoing therapies involving the use of antibiotic, anti-inflammatory or anticoagulant drugs during the month prior to the baseline exam.
  • History of alcohol use or drug abuse.
  • Self-reported pregnancy or lactation.
  • Subjects would be considered inappropriate for the trial if they have a history of pre-existing acute or chronic medical or psychiatric illness and laboratory abnormality which may pose to increase the risk of the subjects involved in the trial or administering the investigational product or may interfere with the interpretation of trial results.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: L-PRF membrane
Periodontal plastic surgical procedures (coronally advanced flap, CAF) in combination with a double layer autologous leucocyte and platelet-rich fibrin (L-PRF) membrane.
Procedure: leucocyte and platelet-rich fibrin (L-PRF) in combination with CAF
Completing root coverage by coronally advanced flap technique in combination with L-PRF.
Active Comparator: Control
CAF
Procedure: CAF
Completing root coverage by coronally advanced flap technique alone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of gingival recession depth (GR) from baseline to 6 months
Time Frame: Baseline, 3 months, and 6 months
Measured from the CEJ to the apical extension of the gingival margin in mm with the use of Florida probe.
Baseline, 3 months, and 6 months
Change of probing pocket depth (PPD) from baseline to 6 months
Time Frame: Baseline, 3 months, and 6 months
Measured from the gingival margin to base of the gingival sulcus in mm with the use of Florida probe.
Baseline, 3 months, and 6 months
Change of clinical attachment level (CAL) from baseline to 6 months
Time Frame: Baseline, 3 months, and 6 months
Measured from cementoenamel junction (CEJ) to the base of the gingival sulcus in mm with the use of Florida probe.
Baseline, 3 months, and 6 months
Change of keratinized mucosa width (KMW) from baseline to 6 months
Time Frame: Baseline, 3 months, and 6 months
Measured from the gingival margin to the mucogingival line in mm with the use of Florida probe.
Baseline, 3 months, and 6 months
Change of thickness of keratinised gingiva (GT) from baseline to 6 months
Time Frame: Baseline, 3 months, and 6 months
Measured 3 mm apical to the gingival margin in mm measured by superimposition of intraoral digital scanning images.
Baseline, 3 months, and 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Concentration of gingival wound fluid molecules
Time Frame: Baseline, 6 hours, 3 days, and 7 days
Concentration changes of the molecules and inflammatory mediators in the wound fluid (WF).
Baseline, 6 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)

September 1, 2019

Primary Completion (Actual)

December 30, 2021

Study Completion (Actual)

December 31, 2022

Study Registration Dates

First Submitted

June 17, 2019

First Submitted That Met QC Criteria

June 18, 2019

First Posted (Actual)

June 20, 2019

Study Record Updates

Last Update Posted (Actual)

February 15, 2023

Last Update Submitted That Met QC Criteria

February 13, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Perio20190614

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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