L-PRF in Alveolar Ridge Preservation

Bone Loss, Alveolar Clinical Trial

— L-PRF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03408418
• Other study ID #: 72596717.3.0000.5259
• Status: Completed
• Phase: N/A
• Start date: March 1, 2018
• Est. completion date: March 1, 2019

Study information

• Verified date: March 2019
• Source: Rio de Janeiro State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: March 1, 2019
• Est. primary completion date: March 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 17 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Alveolar Bone Loss
• Bone Loss, Alveolar

Intervention

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

Locations

Country	Name	City	State
Brazil	Rio de Janeiro State University	Rio De Janeiro

Sponsors (1)

Lead Sponsor	Collaborator
Rio de Janeiro State University

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Width resorption 1mm	The ridge width differences between baseline and after three months of healing 1 mm below the crest.	After 3 months
Secondary	Width resorption 3mm	The ridge width differences between baseline and after three months of healing 3 mm below the crest.	After 3 months
Secondary	Width resorption 5mm	The ridge width differences between baseline and after three months of healing 5 mm below the crest.	After 3 months
Secondary	Histological Analysis - fibrous tissue	The percentage of soft (fibrous) tissue	After 3 months
Secondary	Histological Analysis - bone cells	Quantity of bone cells (osteoblast, osteoclast and osteocyte)	After 3 months
Secondary	Histological Analysis - capillary vessels	Quantity of capillary vessels	After 3 months
Secondary	Histological Analysis - new bone formation	The percentage of the newly formed bone	After 3 months