Ignite Creation Date:
2025-12-25 @ 2:50 AM
Ignite Modification Date:
2026-01-01 @ 12:11 AM
Study NCT ID:
NCT03985033
Status:
COMPLETED
Last Update Posted:
2022-01-11
First Post:
2019-06-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Clinical and Biological Effects of Leucocyte and Platelet-rich Fibrin (L-PRF) on Post-extraction Sockets Healing
Sponsor:
The European Research Group on Periodontology (ERGOPerio)
Organization:
Study Overview
Official Title:
The Clinical and Biological Effects of Leucocyte and Platelet-rich Fibrin (L-PRF) on Post-extraction Sockets Healing: a Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2022-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: