search
Back to results

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

Primary Purpose

Bone Loss, Alveolar

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Platelet-rich fibrin
Sponsored by
Rio de Janeiro State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bone Loss, Alveolar focused on measuring Platelet-rich fibrin, Tooth Extraction, Alveolar Bone Grafting

Eligibility Criteria

17 Years - 65 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Rio de Janeiro State University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

L-PRF group

Control

Arm Description

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

Conventional tooth extraction without any bone substitute.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
January 16, 2018
Last Updated
March 25, 2019
Sponsor
Rio de Janeiro State University
search

1. Study Identification

Unique Protocol Identification Number
NCT03408418
Brief Title
L-PRF in Alveolar Ridge Preservation
Acronym
L-PRF
Official Title
Tomographic and Histological Evaluation of Postextraction Sockets Treated With Leucocyte- and Platelet-rich Fibrin: a Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
March 1, 2019 (Actual)
Study Completion Date
March 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rio de Janeiro State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Loss, Alveolar
Keywords
Platelet-rich fibrin, Tooth Extraction, Alveolar Bone Grafting

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
L-PRF group
Arm Type
Experimental
Arm Description
The use of autologous leucocyte- and platelet-rich fibrin in alveolar sockets after dental extraction.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Conventional tooth extraction without any bone substitute.
Intervention Type
Procedure
Intervention Name(s)
Platelet-rich fibrin
Other Intervention Name(s)
platelet concentrate
Intervention Description
The use of autologous platelet-rich fibrin after tooth extraction to promote bone healing and alveolar ridge preservation
Primary Outcome Measure Information:
Title
Width resorption 1mm
Description
The ridge width differences between baseline and after three months of healing 1 mm below the crest.
Time Frame
After 3 months
Secondary Outcome Measure Information:
Title
Width resorption 3mm
Description
The ridge width differences between baseline and after three months of healing 3 mm below the crest.
Time Frame
After 3 months
Title
Width resorption 5mm
Description
The ridge width differences between baseline and after three months of healing 5 mm below the crest.
Time Frame
After 3 months
Title
Histological Analysis - fibrous tissue
Description
The percentage of soft (fibrous) tissue
Time Frame
After 3 months
Title
Histological Analysis - bone cells
Description
Quantity of bone cells (osteoblast, osteoclast and osteocyte)
Time Frame
After 3 months
Title
Histological Analysis - capillary vessels
Description
Quantity of capillary vessels
Time Frame
After 3 months
Title
Histological Analysis - new bone formation
Description
The percentage of the newly formed bone
Time Frame
After 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
João Canellas, MSc
Organizational Affiliation
Rio de Janeiro State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rio de Janeiro State University
City
Rio De Janeiro
ZIP/Postal Code
20551-030
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31810848
Citation
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.
Results Reference
derived

Learn more about this trial

L-PRF in Alveolar Ridge Preservation

We'll reach out to this number within 24 hrs