Evaluation of Periapical Healing Following Endodontic Microsurgery With Leukocyte and Platelet Rich Fibrin (L-PRF)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Leukocyte and Platelet Rich Fibrin.
- Who it may be relevant to
- Registry conditions: Apical Periodontitis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Procedure 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
Primary outcome measures
- Peri-radicular Healing [Time frame: 12 and 24 months]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Penn Dental Medicine — Philadelphia
Identifiers
NCT: NCT06545084 · 855857