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

NCT03985033 | Completed DMC

• 1 other identifier: HKUPhD20190528
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Tooth Extraction

Outcome Measures

Primary Outcomes (1)

• Concentrations changes of the molecules and inflammatory mediators

  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 Outcomes (5)

• Genes expression profiles

  Baseline and 3 days

• Laser Doppler Flowmetry (LDF) measurement

  Before and immediately after the tooth extraction, 6 hours, 24 hours, 3 days and 7 days

• Radiographic bone changes (Cone-beam computed tomography)

  Baseline and 4 months

• Wound Healing Index (HI)

  6 hours, 24 hours, 3 days and 7 days

• Visual analog scale (VAS)

  6 hours, 24 hours, 3 days and 7 days

Study Arms (2)

L-PRF

EXPERIMENTAL

Post-extraction sockets will be filled with autologous leucocyte and platelet-rich fibrin (L-PRF) clot.

Other: leucocyte and platelet-rich fibrin (L-PRF)

Control

NO INTERVENTION

Post-extraction sockets will be left to heal spontaneously with natural blood clot.

Interventions

leucocyte and platelet-rich fibrin (L-PRF) OTHER

The blood collected from each patient will be centrifuged immediately at 2700 rpm for 12 min to separate L-PRF.

L-PRF

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

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 (24)

• Alssum L, Eubank TD, Roy S, Erdal BS, Yildiz VO, Tatakis DN, Leblebicioglu B. Gingival Perfusion and Tissue Biomarkers During Early Healing of Postextraction Regenerative Procedures: A Prospective Case Series. J Periodontol. 2017 Nov;88(11):1163-1172. doi: 10.1902/jop.2017.170117. Epub 2017 Jun 23.

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• Avila-Ortiz G, Chambrone L, Vignoletti F. Effect of alveolar ridge preservation interventions following tooth extraction: A systematic review and meta-analysis. J Clin Periodontol. 2019 Jun;46 Suppl 21:195-223. doi: 10.1111/jcpe.13057. Erratum In: J Clin Periodontol. 2020 Jan;47(1):129. doi: 10.1111/jcpe.13212.

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• Buser D, Hoffmann B, Bernard JP, Lussi A, Mettler D, Schenk RK. Evaluation of filling materials in membrane--protected bone defects. A comparative histomorphometric study in the mandible of miniature pigs. Clin Oral Implants Res. 1998 Jun;9(3):137-50. doi: 10.1034/j.1600-0501.1998.090301.x.

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• Chan D, Pelekos G, Ho D, Cortellini P, Tonetti MS. The depth of the implant mucosal tunnel modifies the development and resolution of experimental peri-implant mucositis: A case-control study. J Clin Periodontol. 2019 Feb;46(2):248-255. doi: 10.1111/jcpe.13066. Epub 2019 Feb 7.

  PMID: 30638273 BACKGROUND

• Del Fabbro M, Bucchi C, Lolato A, Corbella S, Testori T, Taschieri S. Healing of Postextraction Sockets Preserved With Autologous Platelet Concentrates. A Systematic Review and Meta-Analysis. J Oral Maxillofac Surg. 2017 Aug;75(8):1601-1615. doi: 10.1016/j.joms.2017.02.009. Epub 2017 Feb 20.

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• Franceschi RT. Biological approaches to bone regeneration by gene therapy. J Dent Res. 2005 Dec;84(12):1093-103. doi: 10.1177/154405910508401204.

  PMID: 16304438 BACKGROUND

• Gamal AY, Abdel Ghaffar KA, Alghezwy OA. Crevicular Fluid Growth Factors Release Profile Following the Use of Platelet-Rich Fibrin and Plasma Rich Growth Factors in Treating Periodontal Intrabony Defects: A Randomized Clinical Trial. J Periodontol. 2016 Jun;87(6):654-62. doi: 10.1902/jop.2016.150314. Epub 2016 Feb 15.

  PMID: 26876351 BACKGROUND

• Hammerle CH, Araujo MG, Simion M; Osteology Consensus Group 2011. Evidence-based knowledge on the biology and treatment of extraction sockets. Clin Oral Implants Res. 2012 Feb;23 Suppl 5:80-2. doi: 10.1111/j.1600-0501.2011.02370.x.

  PMID: 22211307 BACKGROUND

• Jung RE, Philipp A, Annen BM, Signorelli L, Thoma DS, Hammerle CH, Attin T, Schmidlin P. Radiographic evaluation of different techniques for ridge preservation after tooth extraction: a randomized controlled clinical trial. J Clin Periodontol. 2013 Jan;40(1):90-8. doi: 10.1111/jcpe.12027. Epub 2012 Nov 19.

  PMID: 23163915 BACKGROUND

• Kampfer H, Pfeilschifter J, Frank S. Expressional regulation of angiopoietin-1 and -2 and the tie-1 and -2 receptor tyrosine kinases during cutaneous wound healing: a comparative study of normal and impaired repair. Lab Invest. 2001 Mar;81(3):361-73. doi: 10.1038/labinvest.3780244.

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• Lin Z, Rios HF, Volk SL, Sugai JV, Jin Q, Giannobile WV. Gene expression dynamics during bone healing and osseointegration. J Periodontol. 2011 Jul;82(7):1007-17. doi: 10.1902/jop.2010.100577. Epub 2010 Dec 13.

  PMID: 21142982 BACKGROUND

• Marenzi G, Riccitiello F, Tia M, di Lauro A, Sammartino G. Influence of Leukocyte- and Platelet-Rich Fibrin (L-PRF) in the Healing of Simple Postextraction Sockets: A Split-Mouth Study. Biomed Res Int. 2015;2015:369273. doi: 10.1155/2015/369273. Epub 2015 Jul 26.

  PMID: 26273612 BACKGROUND

• Miron RJ, Zucchelli G, Pikos MA, Salama M, Lee S, Guillemette V, Fujioka-Kobayashi M, Bishara M, Zhang Y, Wang HL, Chandad F, Nacopoulos C, Simonpieri A, Aalam AA, Felice P, Sammartino G, Ghanaati S, Hernandez MA, Choukroun J. Use of platelet-rich fibrin in regenerative dentistry: a systematic review. Clin Oral Investig. 2017 Jul;21(6):1913-1927. doi: 10.1007/s00784-017-2133-z. Epub 2017 May 27.

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• Moraschini V, Barboza ES. Effect of autologous platelet concentrates for alveolar socket preservation: a systematic review. Int J Oral Maxillofac Surg. 2015 May;44(5):632-41. doi: 10.1016/j.ijom.2014.12.010. Epub 2015 Jan 24.

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• Singh A, Kohli M, Gupta N. Platelet rich fibrin: a novel approach for osseous regeneration. J Maxillofac Oral Surg. 2012 Dec;11(4):430-4. doi: 10.1007/s12663-012-0351-0. Epub 2012 Apr 10.

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• Srinivas B, Das P, Rana MM, Qureshi AQ, Vaidya KC, Ahmed Raziuddin SJ. Wound Healing and Bone Regeneration in Postextraction Sockets with and without Platelet-rich Fibrin. Ann Maxillofac Surg. 2018 Jan-Jun;8(1):28-34. doi: 10.4103/ams.ams_153_17.

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• Tan WL, Wong TL, Wong MC, Lang NP. A systematic review of post-extractional alveolar hard and soft tissue dimensional changes in humans. Clin Oral Implants Res. 2012 Feb;23 Suppl 5:1-21. doi: 10.1111/j.1600-0501.2011.02375.x.

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• Temmerman A, Vandessel J, Castro A, Jacobs R, Teughels W, Pinto N, Quirynen M. The use of leucocyte and platelet-rich fibrin in socket management and ridge preservation: a split-mouth, randomized, controlled clinical trial. J Clin Periodontol. 2016 Nov;43(11):990-999. doi: 10.1111/jcpe.12612. Epub 2016 Sep 21.

  PMID: 27509214 BACKGROUND

• Tonetti M, Cugini MA, Goodson JM. Zero-order delivery with periodontal placement of tetracycline-loaded ethylene vinyl acetate fibers. J Periodontal Res. 1990 Jul;25(4):243-9. doi: 10.1111/j.1600-0765.1990.tb00911.x.

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• Van der Weijden F, Dell'Acqua F, Slot DE. Alveolar bone dimensional changes of post-extraction sockets in humans: a systematic review. J Clin Periodontol. 2009 Dec;36(12):1048-58. doi: 10.1111/j.1600-051X.2009.01482.x.

  PMID: 19929956 BACKGROUND

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  PMID: 12843410 BACKGROUND

• Wang X, Fok MR, Pelekos G, Jin L, Tonetti MS. Increased local concentrations of growth factors from leucocyte- and platelet-rich fibrin do not translate into improved alveolar ridge preservation: An intra-individual mechanistic randomized controlled trial. J Clin Periodontol. 2022 Sep;49(9):889-898. doi: 10.1111/jcpe.13688. Epub 2022 Jul 17.

  PMID: 35734895 DERIVED

MeSH Terms

Interventions

Leukocyte Count

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, DMD

  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: BASIC SCIENCE
• 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 10, 2019
• First Posted: June 13, 2019
• Study Start: October 1, 2019
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: January 11, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)