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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03985033
Enrollment
18
Registered
2019-06-13
Start date
2019-10-01
Completion date
2021-12-31
Last updated
2022-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tooth Extraction

Brief summary

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

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.

Interventions

OTHERleucocyte 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.

Sponsors

The University of Hong Kong
CollaboratorOTHER
The European Research Group on Periodontology (ERGOPerio)
Lead SponsorNETWORK

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Caregiver, Outcomes Assessor)

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Concentrations changes of the molecules and inflammatory mediatorsBaseline, 6 hours, 24 hours, 3 days and 7 daysConcentrations 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

MeasureTime frameDescription
Genes expression profilesBaseline and 3 daysGenes expression profiles of the growth and differentiation factors and inflammatory mediators from the tissue specimen taken from the post-extraction sockets at 3 days.
Laser Doppler Flowmetry (LDF) measurementBefore and immediately after the tooth extraction, 6 hours, 24 hours, 3 days and 7 daysA 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.
Radiographic bone changes (Cone-beam computed tomography)Baseline and 4 monthsCone-beam computed tomography (CBCT) images will be obtained before extraction as the baseline and at the 4 months.
Wound Healing Index (HI)6 hours, 24 hours, 3 days and 7 daysSoft tissue healing will be assessed by Wound Healing Index (1 = very poor, 2 = poor, 3 = good, 4 = very good, 5 = excellent).
Visual analog scale (VAS)6 hours, 24 hours, 3 days and 7 daysA 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.

Countries

Hong Kong

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026