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.

Study Overview

• Status: Recruiting
• Conditions: Apical Periodontitis
• Intervention / Treatment: Procedure: Leukocyte and Platelet Rich Fibrin

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • Penn Dental Medicine
      • Contact: Bekir Karabucak, DMD; Phone Number: 215-898-6062; Email: bekirk@upenn.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Dental Clinic population.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peri-radicular Healing	Evaluate Peri-radicular healing after Endodontic Microsurgery with the use of autologous L-PRF plug.	12 and 24 months

Collaborators and Investigators

• Sponsor: University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: August 5, 2024
• First Submitted That Met QC Criteria: August 5, 2024
• First Posted (Actual): August 9, 2024

Study Record Updates

• Last Update Posted (Estimated): August 27, 2025
• Last Update Submitted That Met QC Criteria: August 20, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periapical Diseases; Jaw Diseases; Periodontitis; Periapical Periodontitis; Investigative Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Cell Count; Cytological Techniques; Hematologic Tests; Cell Physiological Phenomena; Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Blood Cell Count; Leukocyte Count
• Other Study ID Numbers: 855857

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No