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

NCT ID: NCT06545084

Last Updated: 2025-08-27

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-08-01
• Study Completion Date: 2026-06-30

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 Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Penn Dental Medicine

Philadelphia, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Facility Contacts

Bekir Karabucak, DMD

Role: primary

bekirk@upenn.edu

215-898-6062

Other Identifiers

855857

Identifier Type: -

Identifier Source: org_study_id