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Completed

NCT Number: NCT03408418

L-PRF in Alveolar Ridge Preservation

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.

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Key information

Conditions

Bone Loss, Alveolar Alveolar Bone Loss Bone Diseases Bone Resorption Mouth Diseases Musculoskeletal Diseases Periodontal Atrophy Periodontal Diseases Stomatognathic Diseases

Age range

17 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rio de Janeiro State University

Rio de Janeiro, 20551-030, Brazil

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Platelet-rich fibrin

Procedure

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

Other names: platelet concentrate

Primary outcomes

  1. Width resorption 1mm

    Time frame: After 3 months

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

Secondary outcomes

  1. Width resorption 3mm

    Time frame: After 3 months

    The ridge width differences between baseline and after three months of healing 3 mm below the crest.

  2. Width resorption 5mm

    Time frame: After 3 months

    The ridge width differences between baseline and after three months of healing 5 mm below the crest.

  3. Histological Analysis - fibrous tissue

    Time frame: After 3 months

    The percentage of soft (fibrous) tissue

  4. Histological Analysis - bone cells

    Time frame: After 3 months

    Quantity of bone cells (osteoblast, osteoclast and osteocyte)

  5. Histological Analysis - capillary vessels

    Time frame: After 3 months

    Quantity of capillary vessels

  6. Histological Analysis - new bone formation

    Time frame: After 3 months

    The percentage of the newly formed bone

Sponsors and collaborators

Lead sponsor

Rio de Janeiro State University

Other

Registry information

Official study title

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

Acronym: L-PRF

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jan 24, 2018
Registry last updated
Mar 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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