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RecruitingNCT06545084Updated Aug 27, 2025

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

An observational study in Apical Periodontitis, sponsored by University of Pennsylvania. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-27.

Sponsored by University of Pennsylvania · Observational

From the registry’s dates

  • Primary completion was expected by Jun 2026, 3 months ago, but the record still lists the study as recruiting.
  • Started Aug 2024; still recruiting 2 years 2 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Apical Periodontitis
03

In context

Periapical Periodontitis

246 studies on the registry are indexed under Periapical Periodontitis; 64 are open to participants now.

This study's planned enrollment of 50 is below the median of 72 across 33 observational studies indexed under Periapical Periodontitis.

Browse Periapical Periodontitis studies →

Lead sponsor

University of Pennsylvania is the lead sponsor of 1,635 studies on the registry; 239 are open to participants now.

Of its 154 completed or terminated interventional studies of FDA-regulated products, 104 (68%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Dental Clinic population.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. Minors.
  2. Suspected root fractures.
  3. ASA classification 3 or greater.
  4. Periapical pathology Class D, E, or F according to the Kim and Kratchman classification (5).
  5. Patients with history of Oral or IV Bisphosphonate use.
  6. Patients may be excluded if their treatment team do not believe Endodontic microsurgery and L-PRF graft is in the patient's best interests.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (estimated)
Patient registry
No

Interventions

  • ProcedureLeukocyte and Platelet Rich Fibrin

    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.

06

What researchers measure

Primary outcomes

  1. Peri-radicular Healing

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

    Time frame: 12 and 24 months

07

Study locations

1 of 1 sites recruiting
  • Penn Dental Medicine
    Philadelphia, Pennsylvania 19104, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 27, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06545084
Lead sponsor
University of Pennsylvania
Responsible party
Sponsor
First posted
Aug 9, 2024
Start date
Aug 1, 2024
Primary completion
Jun 30, 2026 (estimated)
Completion
Jun 30, 2026 (estimated)
Last update
Aug 27, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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