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

NCT06545084 | Recruiting

• 1 other identifier: 855857
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Peri-radicular Healing

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

  12 and 24 months

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Dental Clinic population.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

Penn Dental Medicine

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MeSH Terms

Conditions

Periapical Periodontitis

Interventions

Leukocyte Count

Condition Hierarchy (Ancestors)

Periapical Diseases; Jaw Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis

Intervention Hierarchy (Ancestors)

Blood Cell Count; Cell Count; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Hematologic Tests; Investigative Techniques; Cell Physiological Phenomena; Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2024
• First Posted: August 9, 2024
• Study Start: August 1, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: August 27, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)