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

NCT03992638 | Completed DMC

• 1 other identifier: Perio20190614
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Gingival Recession

Outcome Measures

Primary Outcomes (5)

• 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.

  Baseline, 3 months, and 6 months

• 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.

  Baseline, 3 months, and 6 months

• 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.

  Baseline, 3 months, and 6 months

• 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.

  Baseline, 3 months, and 6 months

• 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.

  Baseline, 3 months, and 6 months

Secondary Outcomes (1)

• Concentration of gingival wound fluid molecules

  Baseline, 6 hours, 3 days, and 7 days

Study Arms (2)

L-PRF membrane

EXPERIMENTAL

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

Control

ACTIVE COMPARATOR

CAF

Procedure: CAF

Interventions

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

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

L-PRF membrane

CAF PROCEDURE

Completing root coverage by coronally advanced flap technique alone

Control

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The European Research Group on Periodontology (ERGOPerio): lead
• The University of Hong Kong: collaborator

Study Sites (1)

Faculty of Dentistry, The University of Hong Kong

Hong Kong, Hong Kong

Location

Related Publications (33)

• Agudio G, Nieri M, Rotundo R, Franceschi D, Cortellini P, Pini Prato GP. Periodontal conditions of sites treated with gingival-augmentation surgery compared to untreated contralateral homologous sites: a 10- to 27-year long-term study. J Periodontol. 2009 Sep;80(9):1399-405. doi: 10.1902/jop.2009.090122.

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• Cairo F, Rotundo R, Miller PD, Pini Prato GP. Root coverage esthetic score: a system to evaluate the esthetic outcome of the treatment of gingival recession through evaluation of clinical cases. J Periodontol. 2009 Apr;80(4):705-10. doi: 10.1902/jop.2009.080565.

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• Clipet F, Tricot S, Alno N, Massot M, Solhi H, Cathelineau G, Perez F, De Mello G, Pellen-Mussi P. In vitro effects of Choukroun's platelet-rich fibrin conditioned medium on 3 different cell lines implicated in dental implantology. Implant Dent. 2012 Feb;21(1):51-6. doi: 10.1097/ID.0b013e31822b9cb4.

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• Culhaoglu R, Taner L, Guler B. Evaluation of the effect of dose-dependent platelet-rich fibrin membrane on treatment of gingival recession: a randomized, controlled clinical trial. J Appl Oral Sci. 2018 May 14;26:e20170278. doi: 10.1590/1678-7757-2017-0278.

  PMID: 29768524 BACKGROUND

• Dohan Ehrenfest DM, Andia I, Zumstein MA, Zhang CQ, Pinto NR, Bielecki T. Classification of platelet concentrates (Platelet-Rich Plasma-PRP, Platelet-Rich Fibrin-PRF) for topical and infiltrative use in orthopedic and sports medicine: current consensus, clinical implications and perspectives. Muscles Ligaments Tendons J. 2014 May 8;4(1):3-9. eCollection 2014 Jan.

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• Del Pizzo M, Zucchelli G, Modica F, Villa R, Debernardi C. Coronally advanced flap with or without enamel matrix derivative for root coverage: a 2-year study. J Clin Periodontol. 2005 Nov;32(11):1181-7. doi: 10.1111/j.1600-051X.2005.00831.x.

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• Kobayashi E, Fluckiger L, Fujioka-Kobayashi M, Sawada K, Sculean A, Schaller B, Miron RJ. Comparative release of growth factors from PRP, PRF, and advanced-PRF. Clin Oral Investig. 2016 Dec;20(9):2353-2360. doi: 10.1007/s00784-016-1719-1. Epub 2016 Jan 25.

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MeSH Terms

Conditions

Gingival Recession

Interventions

Leukocyte Count

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Intervention Hierarchy (Ancestors)

Blood Cell Count; Cell Count; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Hematologic Tests; Investigative Techniques; Cell Physiological Phenomena; Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Maurizio Tonetti, PhD MMSc

  The European Research Group on Periodontology (ERGOPerio)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Executive Director, Clinical Professor

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

Study Record Dates

• First Submitted: June 17, 2019
• First Posted: June 20, 2019
• Study Start: September 1, 2019
• Primary Completion: December 30, 2021
• Study Completion: December 31, 2022
• Last Updated: February 15, 2023

Record last verified: 2023-02

Locations

HK (1)