NCT06545084 Evaluation of Periapical Healing Following Endodontic Microsurgery With Leukocyte and Platelet Rich Fibrin (L-PRF)
| NCT ID | NCT06545084 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Pennsylvania |
| Condition | Apical Periodontitis |
| Study Type | OBSERVATIONAL |
| Enrollment | 50 participants |
| Start Date | 2024-08-01 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 50 participants in total. It began in 2024-08-01 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Frequently Asked Questions
Who can join the NCT06545084 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Apical Periodontitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06545084 currently recruiting?
Yes, NCT06545084 is actively recruiting participants. Visit ClinicalTrials.gov or contact University of Pennsylvania to inquire about joining.
Where is the NCT06545084 trial being conducted?
This trial is being conducted at Philadelphia, United States.
Who is sponsoring the NCT06545084 clinical trial?
NCT06545084 is sponsored by University of Pennsylvania. The trial plans to enroll 50 participants.