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

Universidade Estadual Paulista Júlio de Mesquita Filho

Status: Unknown

Conditions: Recession, Gingival; Tooth Loss

Treatments: Procedure: Test - Implant with L-PRF; Procedure: Control - Implant without L-PRF

Study type: Interventional

Funder types: Other

Identifiers

NCT03660566

Implante PRF

Details and patient eligibility

About

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.

Full 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.

Enrollment: 42 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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42 participants in 2 patient groups

Test - Implant with L-PRF

Experimental group

Description:

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.

Treatment:

Procedure: Test - Implant with L-PRF

Control - Implant without L-PRF

Active Comparator group

Description:

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

Treatment:

Procedure: Control - Implant without L-PRF