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

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ClinicalTrials.gov Identifier: NCT03985033
Recruitment Status : Recruiting
First Posted : June 13, 2019
Last Update Posted : June 13, 2019
Sponsor:
Collaborator:
The University of Hong Kong
Information provided by (Responsible Party):
Maurizio Tonetti, The University of Hong Kong

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

Condition or disease Intervention/treatment Phase
Tooth Extraction Other: leucocyte and platelet-rich fibrin (L-PRF) Not Applicable

Detailed Description:
Tooth extraction is one of the most frequent dental surgical procedures. Following tooth extraction, dimensional changes of the alveolus are inevitable, which consequently decrease the height and width of alveolar bone and impair ideal implant placement and conventional prosthetic treatment. In order to reduce the bone resorption after tooth extraction, the use of platelet concentrates has been proposed. Platelet rich fibrin (PRF) is a second generation of platelet concentrates consisting of platelets, leukocyte and growth factors harvested from blood. PRF not only supports hemostasis but also favors the natural wound healing process. Over the past decade, PRF has gained tremendous momentum having been utilized for a variety of dental and medical procedures including the management of post-extraction sockets. To date, several studies have assessed the efficacy of the use of PRF in promoting postextraction sockets healing. However, results remain contradictory and mainly focus on the clinical and radiological hard and soft tissue healing, aesthetics and postoperative discomfort. The mechanistic hypothesis is that growth factors released by PRF preparations modulate the wound healing process but the effect of local PRF application on the kinetics of release of wound healing modulators has not been studied so far. There is also a lack of information in the literature regarding the biological evaluation during postextraction sockets healing to understand the potential mechanisms. In order to assess the presence or follow dynamics of biomarkers, in this study wound fluid (WF) will be collected from the post-extraction sockets and utilized for multiplex immunoassay. Multiplex immunoassay allows simultaneous quantification of multiple markers providing unique information for a more complete understanding of the potential mechanism of PRF and spontaneous extraction socket healing. Therefore, the aim of this randomized clinical trial is to evaluate the effects of PRF on biomarkers response during post-extraction sockets healing.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 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: Basic Science
Official Title: The Clinical and Biological Effects of Leucocyte and Platelet-rich Fibrin (L-PRF) on Post-extraction Sockets Healing: a Randomized Controlled Trial
Estimated Study Start Date : June 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : March 31, 2021

Arm Intervention/treatment
Experimental: L-PRF
Post-extraction sockets will be filled with autologous leucocyte and platelet-rich fibrin (L-PRF) clot.
Other: leucocyte and platelet-rich fibrin (L-PRF)
The blood collected from each patient will be centrifuged immediately at 2700 rpm for 12 min to separate L-PRF.

No Intervention: Control
Post-extraction sockets will be left to heal spontaneously with natural blood clot.



Primary Outcome Measures :
  1. Concentrations changes of the molecules and inflammatory mediators [ Time Frame: Baseline, 6 hours, 24 hours, 3 days and 7 days ]
    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.


Secondary Outcome Measures :
  1. Genes expression profiles [ Time Frame: Baseline and 3 days ]
    Genes expression profiles of the growth and differentiation factors and inflammatory mediators from the tissue specimen taken from the post-extraction sockets at 3 days.

  2. Laser Doppler Flowmetry (LDF) measurement [ Time Frame: Before and immediately after the tooth extraction, 6 hours, 24 hours, 3 days and 7 days ]
    A commercially available Laser Doppler Blood FlowMeter equipped with a standard fiber optic probe will be used for LDF measurements before tooth extraction, immediately postoperatively, 6 hours, 24 hours, 3 days and 7 days.

  3. Radiographic bone changes (Cone-beam computed tomography) [ Time Frame: Baseline and 4 months ]
    Cone-beam computed tomography (CBCT) images will be obtained before extraction as the baseline and at the 4 months.

  4. Wound Healing Index (HI) [ Time Frame: 6 hours, 24 hours, 3 days and 7 days ]
    Soft tissue healing will be assessed by Wound Healing Index (1 = very poor, 2 = poor, 3 = good, 4 = very good, 5 = excellent).

  5. Visual analog scale (VAS) [ Time Frame: 6 hours, 24 hours, 3 days and 7 days ]
    A 10-point VAS with a score of 0 that equals "no pain" and a score of 10 that equals "worst pain imaginable" will be used to evaluate the postoperative pain at 6 hours, 24 hours, 3 days and 7 days. The patients will be asked to fill the pain they feel at the time of questioning. Questionnaires will be collected at the one-week follow-up visit.



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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:

  • 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

Exclusion Criteria:

  • 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

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): NCT03985033


Contacts
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Contact: Maurizio Tonetti, PhD, DMD +852 28590297 tonetti@hku.hk
Contact: Xuzhu Wang +852 66707303 wangxz@hku.hk

Locations
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Hong Kong
Faculty of Dentistry, The University of Hong Kong Recruiting
Hong Kong, Hong Kong
Contact: Maurizio Tonetti, PhD, DMD    +852 28590297    tonetti@hku.hk   
Contact: Xuzhu Wang    +852 66707303    wangxuzhu@whu.edu.cn   
Principal Investigator: Maurizio Tonetti, PhD, DMD         
Sponsors and Collaborators
The European Research Group on Periodontology (ERGOPerio)
The University of Hong Kong

Publications:

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Responsible Party: Maurizio Tonetti, Executive Director, Clinical Professor, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT03985033     History of Changes
Other Study ID Numbers: HKUPhD20190528
First Posted: June 13, 2019    Key Record Dates
Last Update Posted: June 13, 2019
Last Verified: June 2019
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