L-PRF in Alveolar Ridge Preservation (L-PRF)

Tomographic and Histological Evaluation of Postextraction Sockets Treated With Leucocyte- and Platelet-rich Fibrin: a Randomized Clinical Trial

The effect of leucocyte- and platelet-rich fibrin (L-PRF) for enhancing the healing after dental extractions is still a matter of debate. The available literature suggests that L-PRF performs positive effect to improve alveolar preservation resulting in less bone resorption on extraction sockets. L-PRF is a second generation of platelet concentrate produced without biochemical blood manipulation. L-PRF is composed by three key parameters: first, the presence of platelets; second, the presence of leucocytes; third, the density and complex organization of the fibrin matrix architecture produced by a natural polymerization process. The theory is that this key parameters acts to produce a faster bone healing.

Study Overview

• Status: Completed
• Conditions: Bone Loss, Alveolar
• Intervention / Treatment: Procedure: Platelet-rich fibrin

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Rio De Janeiro, Brazil, 20551-030
    • Rio de Janeiro State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• (1) Health patients, American Society of Anesthesiologists (ASA) I or II
• (2) Patients who need to submit tooth extraction (pre-molar, canine and incisor teeth - uniradicular teeth or teeth with fused roots) which present ideal conditions to receive dental implants after 3 months.

Exclusion Criteria:

• Smoking
• Systemic diseases related with healing disorders
• Poor oral hygiene
• Pregnant or lactating patient
• Use of flap elevation for dental extraction

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: L-PRF group; The use of autologous leucocyte- and platelet-rich fibrin in alveolar sockets after dental extraction.	Procedure: Platelet-rich fibrin; The use of autologous platelet-rich fibrin after tooth extraction to promote bone healing and alveolar ridge preservation; Other Names: platelet concentrate
No Intervention: Control; Conventional tooth extraction without any bone substitute.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Width resorption 1mm	The ridge width differences between baseline and after three months of healing 1 mm below the crest.	After 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Width resorption 3mm	The ridge width differences between baseline and after three months of healing 3 mm below the crest.	After 3 months
Width resorption 5mm	The ridge width differences between baseline and after three months of healing 5 mm below the crest.	After 3 months
Histological Analysis - fibrous tissue	The percentage of soft (fibrous) tissue	After 3 months
Histological Analysis - bone cells	Quantity of bone cells (osteoblast, osteoclast and osteocyte)	After 3 months
Histological Analysis - capillary vessels	Quantity of capillary vessels	After 3 months
Histological Analysis - new bone formation	The percentage of the newly formed bone	After 3 months

Collaborators and Investigators

• Sponsor: Rio de Janeiro State University
• Investigators: Principal Investigator: João Canellas, MSc, Rio de Janeiro State University

Publications and helpful links

General Publications

• Canellas JVDS, da Costa RC, Breves RC, de Oliveira GP, Figueredo CMDS, Fischer RG, Thole AA, Medeiros PJD, Ritto FG. Tomographic and histomorphometric evaluation of socket healing after tooth extraction using leukocyte- and platelet-rich fibrin: A randomized, single-blind, controlled clinical trial. J Craniomaxillofac Surg. 2020 Jan;48(1):24-32. doi: 10.1016/j.jcms.2019.11.006. Epub 2019 Nov 29.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2018
• Primary Completion (Actual): March 1, 2019
• Study Completion (Actual): March 1, 2019

Study Registration Dates

• First Submitted: January 16, 2018
• First Submitted That Met QC Criteria: January 22, 2018
• First Posted (Actual): January 24, 2018

Study Record Updates

• Last Update Posted (Actual): March 26, 2019
• Last Update Submitted That Met QC Criteria: March 25, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Tooth Extraction; Platelet-rich fibrin; Alveolar Bone Grafting
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Bone Diseases; Periodontal Atrophy; Bone Resorption; Alveolar Bone Loss
• Other Study ID Numbers: 72596717.3.0000.5259

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No