Clinical trial NCT03985033: The Clinical and Biological Effects of Leucocyte and Platelet-rich Fibrin (L-PRF) on Post-extraction Sockets Healing
Official title: The Clinical and Biological Effects of Leucocyte and Platelet-rich Fibrin (L-PRF) on Post-extraction Sockets Healing: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tooth Extraction
Lead sponsor: The European Research Group on Periodontology (ERGOPerio)
Sponsor class: NETWORK
Collaborators: name: The University of Hong Kong
First posted: 2019-06-13
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Split-mouth design allowing to assess two types of treatment in the same patient.
Primary purpose: BASIC_SCIENCE

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.

Eligibility 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

Primary outcomes:
measure: Concentrations changes of the molecules and inflammatory mediators
timeFrame: Baseline, 6 hours, 24 hours, 3 days and 7 days
Secondary outcomes:
measure: Genes expression profiles
timeFrame: Baseline and 3 days
measure: Laser Doppler Flowmetry (LDF) measurement
timeFrame: Before and immediately after the tooth extraction, 6 hours, 24 hours, 3 days and 7 days
measure: Radiographic bone changes (Cone-beam computed tomography)
timeFrame: Baseline and 4 months
measure: Wound Healing Index (HI)
timeFrame: 6 hours, 24 hours, 3 days and 7 days
measure: Visual analog scale (VAS)
timeFrame: 6 hours, 24 hours, 3 days and 7 days
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Faculty of Dentistry, The University of Hong Kong
Study officials:
affiliation: The European Research Group on Periodontology (ERGOPerio)
name: Maurizio Tonetti, DMD
role: PRINCIPAL_INVESTIGATOR
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