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

NCT ID: NCT03660566

Last Updated: 2020-09-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-10
• Study Completion Date: 2020-11-20

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.

Conditions

Tooth Loss; Recession, Gingival

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Test - Implant with L-PRF

Patients requiring single implants placement in the esthetic area of maxilla will receive the implant placement with the use of Leucocyte- and Platelet-rich fibrin (L-PRF) membranes.

Group Type: EXPERIMENTAL

Test - Implant with L-PRF

Intervention Type: PROCEDURE

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.

Control - Implant without L-PRF

Patients requiring single implants placement in the esthetic area of maxilla will receive the implant placement only.

Group Type: ACTIVE_COMPARATOR

Control - Implant without L-PRF

Intervention Type: PROCEDURE

Single implant installation surgery in maxillary esthetic area.

Interventions

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.

Intervention Type: PROCEDURE

Control - Implant without L-PRF

Single implant installation surgery in maxillary esthetic area.

Intervention Type: PROCEDURE

Other Intervention Names

Single implant placement with the use of L-PRF membranes; Single implant placement without the use of L-PRF membranes

Eligibility Criteria

Inclusion Criteria

• Patients of at least 20 years of age, systemically healthy, with satisfactory oral hygiene assessed by plaque index and gingival index of less than 25% (O'Leay et al. 1972).
• Patients requiring single implant placement in anterior maxilla (premolar to premolar)
• Buccal soft tissue thickness of at least 2mm
• Patients who agreed to participate in the study and signed a written consent (Resolution nº196 of October 1996 and the Code of Professional Ethics Dental - C.F.O. - 179/93)

Exclusion Criteria

• Smokers
• Patients with parafunctional habits, such as bruxism
• Patients who need other types of rehabilitation, such as removable prostheses
• Pregnant or lactating
• Patients with uncontrolled systemic diseases (cardiovascular alterations, blood disorders, diseases that affect bone metabolism, immunodeficiencies, diabetes)
• Patients who use drugs that interfere with wound healing or contraindicate the surgical procedure, such as gingival growth related drugs
• Implants in adjacent regions
• Sites requiring bone augmentation procedure
• Patients in orthodontic treatment

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universidade Estadual Paulista Júlio de Mesquita Filho

OTHER

Sponsor Role: lead

Responsible Party

Maria Aparecida Neves Jardini

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Maria A Jardini, Doctor

Role: PRINCIPAL_INVESTIGATOR

State of São paulo University

Locations

Maria Jardini

São Jose Dos Campos, São Paulo, Brazil

Countries

Brazil

Other Identifiers

Implante PRF

Identifier Type: -

Identifier Source: org_study_id