Recruiting

L-PRF

Sponsor:

University of Pennsylvania

Code:

NCT06545084

Conditions

Apical Periodontitis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Leukocyte and Platelet Rich Fibrin

Study Details

Brief 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.

Conditions

Apical Periodontitis

Study ID

NCT06545084

Start date

Aug 1, 2024

Status verified date

Aug, 2025

Completion date

Jun 30, 2026

Anticipated

Primary completion date

Jun 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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:

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.

Study Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Interventions

Leukocyte 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.

Primary outcome measure

  • Peri-radicular Healing [ Time Frame: 12 and 24 months ]

Central Contacts and Locations

Locations

Penn Dental Medicine

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Bekir Karabucak, DMD

215-898-6062bekirk@upenn.edu

More Information

Sponsor

University of Pennsylvania

Last update posted

Aug 27, 2025

Last verified

Aug, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Pennsylvania on 2025-08-27.