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NCT Number: NCT06545084

Evaluation of Periapical Healing Following Endodontic Microsurgery With Leukocyte and Platelet Rich Fibrin (L-PRF)

The purpose of the study is to evaluate peri-radicular healing after root-end surgery using Leukocyte and Platelet Rich Fibrin. The study population includes patients diagnosed with persistent periapical pathology and scheduled for Endodontic Microsurgery at the University of Pennsylvania School of Dental Medicine, Department of Endodontics. Patients undergoing routine endodontic microsurgery and who meet the inclusion criteria will be given the opportunity to opt in to receive L-PRF in the osteotomy site to promote bone formation. Healing will be assessed radiographically and clinically at six, twelve, eighteen, and twenty-four months.

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Key information

Conditions

Apical Periodontitis Jaw Diseases Mouth Diseases Periapical Diseases Periapical Periodontitis Periodontal Diseases Periodontitis Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Penn Dental Medicine

Philadelphia, Pennsylvania, 19104, United States

Location status: Recruiting

Location contact

Bekir Karabucak, DMD

CONTACT

[email protected]

215-898-6062

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Provision of signed and dated informed consent form.
  • Stated willingness to comply with all study procedures and availability for the duration of the study, including the follow-up visits.
  • Male or Female age >18 years old.
  • In good general health (ASA 2 or less) with no contraindications for Endodontic Microsurgery.
  • Persistent endodontic periapical pathology Class A, B, or C according to the Kim and Kratchman classification (5)
  • Intact coronal restorations with no evidence of leakage or caries under the restoration.

Exclusion criteria

  • Minors.
  • Suspected root fractures.
  • ASA classification 3 or greater.
  • Periapical pathology Class D, E, or F according to the Kim and Kratchman classification (5).
  • Patients with history of Oral or IV Bisphosphonate use.
  • Patients may be excluded if their treatment team do not believe Endodontic microsurgery and L-PRF graft is in the patient's best interests.

Treatment and study plan

Leukocyte and Platelet Rich Fibrin

Procedure

Leukocyte Platelet Rich Fibrin (L-PRF) is a collection of growth factors rich in proinflammatory cells that promote healing after dental surgery. A L-PRF clot is obtained by collecting blood from the subject, similar to a phlebotomist drawing blood via venipuncture. The blood samples are spun in a centrifuge using the recommended settings by the manufacture(1). The resultant product has separated the red blood cells from the L-PRF clot which is placed back into the subject to promote healing of the surgical site.

Primary outcomes

  1. Peri-radicular Healing

    Time frame: 12 and 24 months

    Evaluate Peri-radicular healing after Endodontic Microsurgery with the use of autologous L-PRF plug.

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 9, 2024
Registry last updated
Aug 27, 2025

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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