NCT03660566

Use of Leucocyte- and Platelet-rich Fibrin Membranes in Single Implant

Use of Leucocyte- and Platelet-rich Fibrin (L-PRF) Membranes in Single Implant Placement on Esthetic Area. Randomized Clinical Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 42 (estimated)
• Sponsor: Universidade Estadual Paulista Júlio de Mesquita Filho · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Accepted

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.

Conditions

• Tooth Loss
• Recession, Gingival

Interventions

Type	Name	Description
PROCEDURE	Test - Implant with L-PRF	The patient's blood will be collected and the tubes (4) will be inserted into a tabletop centrifuge (Kasvi). Using a 2500rpm for 12 minutes protocol, the leucocyte- and platelet-rich fibrin clot will be prepared using a kit consisting of a perforated metal box where the clots will be positioned and covered by a metal plaque. The pressure exerted on the clot will lead to the formation of L-PRF membranes, which will be used to cover the ridge after placement of the implant. Then, the flap will be sutured.
PROCEDURE	Control - Implant without L-PRF	Single implant installation surgery in maxillary esthetic area.

Timeline

• Start date: 2018-08-10
• Primary completion: 2020-07-21
• Completion: 2020-11-20
• First posted: 2018-09-06
• Last updated: 2020-09-16

Locations

1 site across 1 country: Brazil