NCT03408418

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 16, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 24, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

March 26, 2019

Status Verified

March 1, 2019

Enrollment Period

1 year

First QC Date

January 16, 2018

Last Update Submit

March 25, 2019

Conditions

Bone Loss, Alveolar

Keywords

Platelet-rich fibrinTooth ExtractionAlveolar Bone Grafting

Outcome Measures

Primary Outcomes (1)

  • Width resorption 1mm

    The ridge width differences between baseline and after three months of healing 1 mm below the crest.

    After 3 months

Secondary Outcomes (6)

  • Width resorption 3mm

    After 3 months

  • Width resorption 5mm

    After 3 months

  • Histological Analysis - fibrous tissue

    After 3 months

  • Histological Analysis - bone cells

    After 3 months

  • Histological Analysis - capillary vessels

    After 3 months

  • +1 more secondary outcomes

Study Arms (2)

L-PRF group

EXPERIMENTAL

The use of autologous leucocyte- and platelet-rich fibrin in alveolar sockets after dental extraction.

Procedure: Platelet-rich fibrin

Control

NO INTERVENTION

Conventional tooth extraction without any bone substitute.

Interventions

Platelet-rich fibrinPROCEDURE

The use of autologous platelet-rich fibrin after tooth extraction to promote bone healing and alveolar ridge preservation

Also known as: platelet concentrate
L-PRF group

Eligibility Criteria

Age17 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • (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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rio de Janeiro State University

Rio de Janeiro, 20551-030, Brazil

Location

Related Publications (1)

  • 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.

    PMID: 31810848DERIVED

MeSH Terms

Conditions

Alveolar Bone Loss

Condition Hierarchy (Ancestors)

Bone ResorptionBone DiseasesMusculoskeletal DiseasesPeriodontal AtrophyPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • João Canellas, MSc

    Rio de Janeiro State 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
PhD Student

Study Record Dates

First Submitted

January 16, 2018

First Posted

January 24, 2018

Study Start

March 1, 2018

Primary Completion

March 1, 2019

Study Completion

March 1, 2019

Last Updated

March 26, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)