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

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ClinicalTrials.gov Identifier: NCT03992638
Recruitment Status : Active, not recruiting
First Posted : June 20, 2019
Last Update Posted : August 27, 2021
Sponsor:
Collaborator:
The University of Hong Kong
Information provided by (Responsible Party):
Maurizio Tonetti, The European Research Group on Periodontology (ERGOPerio)

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

Condition or disease Intervention/treatment Phase
Gingival Recession Procedure: leucocyte and platelet-rich fibrin (L-PRF) in combination with CAF Procedure: CAF Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Split-mouth design allowing to assess two types of treatment in the same patient.
Masking: Double (Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Mechanisms of LPRF Action in the Promotion of Wound Healing and Tissue Regeneration: A Randomised Controlled Trial
Actual Study Start Date : September 1, 2019
Estimated Primary Completion Date : December 30, 2021
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.


Secondary Outcome Measures :
  1. 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).



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03992638


Locations
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Hong Kong
Faculty of Dentistry, The University of Hong Kong
Hong Kong, Hong Kong
Sponsors and Collaborators
The European Research Group on Periodontology (ERGOPerio)
The University of Hong Kong
Investigators
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Principal Investigator: Maurizio Tonetti, PhD MMSc The European Research Group on Periodontology (ERGOPerio)
Publications:

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Responsible Party: Maurizio Tonetti, Executive Director, Clinical Professor, The European Research Group on Periodontology (ERGOPerio)
ClinicalTrials.gov Identifier: NCT03992638    
Other Study ID Numbers: Perio20190614
First Posted: June 20, 2019    Key Record Dates
Last Update Posted: August 27, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Gingival Recession
Gingival Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Periodontal Atrophy