PRF Membrane and Recovery After Periapical Surgery: A 3D Imaging Study (NCT06739200) | Clinical Trial Compass
CompletedNot Applicable
PRF Membrane and Recovery After Periapical Surgery: A 3D Imaging Study
Hungary20 participantsStarted 2023-09-04
Plain-language summary
The goal of this clinical trial is to determine whether a PRF (platelet-rich fibrin) membrane helps improve recovery after periapical surgery in adults. The main questions it seeks to answer are:
Does the use of a PRF membrane reduce swelling and pain after surgery? Does the use of a PRF membrane improve healing as observed on 3D imaging? Researchers will compare the outcomes of participants who receive a PRF membrane during surgery with those who do not, to assess whether the PRF membrane improves recovery.
Participants will:
Undergo periapical surgery with or without the use of a PRF membrane. Have swelling and pain assessed at specific time points after surgery. Participate in 3D imaging scans to evaluate healing.
Participants will:
Undergo periapical surgery with or without the use of a PRF membrane. Have swelling and pain measured at specific time points after surgery. Take part in 3D imaging scans to evaluate healing.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adults aged 20-65 years, both male and female.
* Diagnosed with periapical disease, including periapical cysts or granulomas.
* Requiring periapical surgery as part of their treatment plan.
* Presenting a tooth needing endodontic surgery with periradicular lesions of strictly endodontic origin.
* Size of the bone crypt between 6 mm and 12 mm.
* Non-surgical retreatment considered unfeasible or previously failed.
* Apical root canal free from posts over a length of at least 6 mm.
* Adequate coronal restoration without coronal leakage.
* Willing and able to provide written informed consent.
* Capable of attending follow-up visits and participating in required assessments.
* Maxillary and mandibular teeth limited to the 2nd premolar to 2nd premolar regions.
* Without general medical contraindications for oral surgical procedures.
Exclusion Criteria:
* Patients with systemic conditions affecting healing, such as:
* • Uncontrolled diabetes mellitus.
* • Autoimmune disorders.
* • Chronic inflammatory diseases.
* Pregnant or breastfeeding individuals.
* Use of medications or therapies that may interfere with healing, including:
* • Bisphosphonates.
* • Immunosuppressants.
* • Radiotherapy.
* • Oncological therapies (e.g., chemotherapy, immunotherapy).
* Requires antibiotic prophylaxis or therapy.
* History of allergies or adverse reactions to blood-derived products.
* Neuropsychiatric disorders.
* Active infection or severe periodontal diseas…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Quality of Life (QoL) Using the PROMIS-29+2 Profile v2.1
Timeframe: Preoperative and Day 7 postoperative.
2
Change in Pain Intensity Using the Visual Analog Scale (VAS)
Timeframe: Daily assessments from Day 0 (day of surgery) to Day 7 postoperative.
3
Change in Postoperative Swelling Using 3D Optical Scans
Timeframe: Measurements were taken at T0 (preoperative) and T1 (Day 3 postoperative).