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

Primary Purpose

Gingival Recession

Status

Completed

Phase

Not Applicable

Locations

Hong Kong

Study Type

Interventional

Intervention

leucocyte and platelet-rich fibrin (L-PRF) in combination with CAF

CAF

About this trial

This is an interventional treatment trial for Gingival Recession

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Faculty of Dentistry, The University of Hong Kong

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

L-PRF membrane

Control

Arm Description

Periodontal plastic surgical procedures (coronally advanced flap, CAF) in combination with a double layer autologous leucocyte and platelet-rich fibrin (L-PRF) membrane.

CAF

Outcomes

Primary Outcome Measures

Change of gingival recession depth (GR) from baseline to 6 months

Measured from the CEJ to the apical extension of the gingival margin in mm with the use of Florida probe.

Change of probing pocket depth (PPD) from baseline to 6 months

Measured from the gingival margin to base of the gingival sulcus in mm with the use of Florida probe.

Change of clinical attachment level (CAL) from baseline to 6 months

Measured from cementoenamel junction (CEJ) to the base of the gingival sulcus in mm with the use of Florida probe.

Change of keratinized mucosa width (KMW) from baseline to 6 months

Measured from the gingival margin to the mucogingival line in mm with the use of Florida probe.

Change of thickness of keratinised gingiva (GT) from baseline to 6 months

Measured 3 mm apical to the gingival margin in mm measured by superimposition of intraoral digital scanning images.

Secondary Outcome Measures

Concentration of gingival wound fluid molecules

Concentration changes of the molecules and inflammatory mediators in the wound fluid (WF).

Full Information

NCT ID

NCT03992638

First Posted

June 17, 2019

Last Updated

February 13, 2023

Sponsor

The European Research Group on Periodontology (ERGOPerio)

Collaborators

The University of Hong Kong

1. Study Identification

Unique Protocol Identification Number

NCT03992638

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Completed

Study Start Date

September 1, 2019 (Actual)

Primary Completion Date

December 30, 2021 (Actual)

Study Completion Date

December 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The European Research Group on Periodontology (ERGOPerio)

Collaborators

The University of Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gingival Recession

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Split-mouth design allowing to assess two types of treatment in the same patient.

Masking

Care ProviderOutcomes Assessor

Allocation

Randomized

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

L-PRF membrane

Arm Type

Experimental

Arm Description

Periodontal plastic surgical procedures (coronally advanced flap, CAF) in combination with a double layer autologous leucocyte and platelet-rich fibrin (L-PRF) membrane.

Arm Title

Control

Arm Type

Active Comparator

Arm Description

CAF

Intervention Type

Procedure

Intervention Name(s)

leucocyte and platelet-rich fibrin (L-PRF) in combination with CAF

Intervention Description

Completing root coverage by coronally advanced flap technique in combination with L-PRF.

Intervention Type

Procedure

Intervention Name(s)

CAF

Intervention Description

Completing root coverage by coronally advanced flap technique alone

Primary Outcome Measure Information:

Title

Change of gingival recession depth (GR) from baseline to 6 months

Description

Measured from the CEJ to the apical extension of the gingival margin in mm with the use of Florida probe.

Time Frame