Clinical trial NCT03660566: Use of Leucocyte- and Platelet-rich Fibrin Membranes in Single Implant
Official title: Use of Leucocyte- and Platelet-rich Fibrin (L-PRF) Membranes in Single Implant Placement on Esthetic Area. Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tooth Loss
Recession, Gingival
Keywords: Platelet-Rich Fibrin
Dental Implant
Lead sponsor: Universidade Estadual Paulista Júlio de Mesquita Filho
Sponsor class: OTHER
First posted: 2018-09-06
Enrollment: 42
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Gain of peri-implant soft tissue thickness
timeFrame: Three months
Secondary outcomes:
measure: a) Plaque index (IP, Ainamo e Bay. 1975)
timeFrame: Three months
measure: b) Gingival bleeding index (IG, Ainamo & Bay, 1975)
timeFrame: Three months
measure: c) Buccal keratinized tissue thickness (ETQv)
timeFrame: Three months
measure: d) Ridge defect (DR) (ridge valley)
timeFrame: Three months
measure: e) Soft tissue height (ATM)
timeFrame: Three months
measure: f) Height of keratinized tissue (ATQ)
timeFrame: Three months
measure: g) Distance between the teeth adjacent to the edentulous space (DED)
timeFrame: Three months
measure: h) Vestibular bone plate thickness (ETV)
timeFrame: During the surgical procedure
measure: i) Distance between implant and adjacent teeth (DEID)
timeFrame: During the surgical procedure
measure: j) Distance from the implant to the imaginary line passing by the buccal aspect of the adjacent teeth (DILIV)
timeFrame: During the surgical procedure
measure: k) Distance from the buccal bone plate to the imaginary line of the adjacent teeth (DTOVLI)
timeFrame: During the surgical procedure
measure: l) Distance from the interproximal bone crest to the cementum-enamel junction of neighboring teeth (DCOJCE)
timeFrame: During the surgical procedure
measure: m) Evaluation of the periodontal biotype (thin or thick)
timeFrame: Three months
Other outcomes:
measure: Aesthetic (based on the patient's opinion)
timeFrame: One year
measure: Postoperative discomfort
timeFrame: Seven days
measure: Postoperative discomfort (based on analgesics)
timeFrame: Seven days
measure: Evaluation of oral health impact on quality of life, using the Oral Health Impact Profile (OHIP-14) questionnaire.
timeFrame: One year
Locations:
city: São Jose dos Campos
country: Brazil
facility: Maria Jardini
state: São Paulo
Study officials:
affiliation: State of São paulo University
name: Maria A Jardini, Doctor
role: PRINCIPAL_INVESTIGATOR
References: