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

NCT03660566 | Unknown

• 1 other identifier: Implante PRF
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Tooth Loss; Recession, Gingival

Keywords

Platelet-Rich Fibrin; Dental Implant

Outcome Measures

Primary Outcomes (1)

• Gain of peri-implant soft tissue thickness

  A single investigator, who is not the operator, is responsible for the measurements of the patients. The examiner will be judged calibrated. The calibration will be made by examination of soft tissue thickness of 5 patients, twice, in a range of 48 hours. The correlation test will be used to verify the reproducibility of intra-examining measures, with a maximum value of 0.8. To ensure that the measures at baseline and postoperative evaluation will be performed at the same place, we will use a stent, made of condensation silicone (Optosil - Heraeus Kulzer), so as to cover the edentulous region and the regions of interest described by Zeltner et al. (2017). During measurements of soft tissue thickness, the stent will be used so that the tissue perforation site will be standardized, according to a marking on its surface. An endodontic spacer will be used for tissue perforation, and the thickness will be evaluated using a digital caliper.

  Three months

Secondary Outcomes (13)

• a) Plaque index (IP, Ainamo e Bay. 1975)

  Three months

• b) Gingival bleeding index (IG, Ainamo & Bay, 1975)

  Three months

• c) Buccal keratinized tissue thickness (ETQv)

  Three months

• d) Ridge defect (DR) (ridge valley)

  Three months

• e) Soft tissue height (ATM)

  Three months

Other Outcomes (4)

• Aesthetic (based on the patient's opinion)

  One year

• Postoperative discomfort

  Seven days

• Postoperative discomfort (based on analgesics)

  Seven days

Study Arms (2)

Test - Implant with L-PRF

EXPERIMENTAL

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.

Procedure: Test - Implant with L-PRF

Control - Implant without L-PRF

ACTIVE COMPARATOR

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

Procedure: Control - Implant without L-PRF

Interventions

Test - Implant with L-PRF 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.

Also known as: Single implant placement with the use of L-PRF membranes

Test - Implant with L-PRF

Control - Implant without L-PRF PROCEDURE

Single implant installation surgery in maxillary esthetic area.

Also known as: Single implant placement without the use of L-PRF membranes

Control - Implant without L-PRF

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidade Estadual Paulista Júlio de Mesquita Filho: lead

Study Sites (1)

Maria Jardini

São Jose Dos Campos, São Paulo, 12245 000, Brazil

Location

MeSH Terms

Conditions

Tooth Loss; Gingival Recession

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Tooth Diseases; Gingival Diseases; Periodontal Atrophy

Study Officials

• Maria A Jardini, Doctor

  State of São paulo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: July 4, 2018
• First Posted: September 6, 2018
• Study Start: August 10, 2018
• Primary Completion: July 21, 2020
• Study Completion: November 20, 2020
• Last Updated: September 16, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)