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NCT Number: NCT03985033

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

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

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Key information

Conditions

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, The University of Hong Kong

Hong Kong

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

The European Research Group on Periodontology (ERGOPerio)

Network

Collaborators

  • The University of Hong Kong

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jun 13, 2019
Registry last updated
Jan 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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