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 range18 Years – 65 Years

SexALL

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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…

What they're measuring

Change in Quality of Life (QoL) Using the PROMIS-29+2 Profile v2.1

Timeframe: Preoperative and Day 7 postoperative.

Change in Pain Intensity Using the Visual Analog Scale (VAS)

Timeframe: Daily assessments from Day 0 (day of surgery) to Day 7 postoperative.

Change in Postoperative Swelling Using 3D Optical Scans

Timeframe: Measurements were taken at T0 (preoperative) and T1 (Day 3 postoperative).

Trial details

NCT IDNCT06739200

SponsorSemmelweis University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-11-05

View on ClinicalTrials.gov More Periapical Diseases trials