Ignite Creation Date:
2025-12-24 @ 4:05 PM
Ignite Modification Date:
2026-02-18 @ 1:20 AM
Study NCT ID:
NCT03660566
Status:
UNKNOWN
Last Update Posted:
2020-09-16
First Post:
2018-07-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of Leucocyte- and Platelet-rich Fibrin Membranes in Single Implant
Sponsor:
Universidade Estadual Paulista Júlio de Mesquita Filho
Organization:
Study Overview
Official Title:
Use of Leucocyte- and Platelet-rich Fibrin (L-PRF) Membranes in Single Implant Placement on Esthetic Area. Randomized Clinical Trial
Status:
UNKNOWN
Status Verified Date:
2020-09
Last Known Status:
ENROLLING_BY_INVITATION
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:
The objective of this randomized controlled clinical trial is to evaluate the increase of soft tissue thickness around single implants installed in maxillary esthetic area with the use of Leucocyte-Platelet rich Fibrin (L-PRF) membranes. The sample is of 42 individuals, where the control group (n = 21) will receive single implant placement only, while the test group will receive single implant placement with L-PRF membranes.
Detailed Description:
The greatest challenge in implantology is to achieve a satisfactory esthetic result. A new platelet concentrate protocol, named Leucocyte and platelet-rich Fibrin (L-PRF), has been developed in France. Research has shown positive results using L-PRF during implant placement, as improving soft tissue healing and bone formation, leading to higher esthetic level and greater implant stability. The aim of this study is to evaluate if the use of PRF associated to implant placement in esthetic area presents superior aesthetic result and soft tissue thickness increase when compared to implant placement without graft. Forty-two patients requiring single implant placement in the esthetic area of the maxilla will be randomly divided into test group (implant + L-PRF) and control group (implant without graft). Surgical procedures will be performed by a single operator. The rates of soft tissue thickness, esthetic and comfort will be evaluated at baseline and 3 months after the procedure.
Study Oversight
Has Oversight DMC:
False
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?: