PRF Membrane and Recovery After Periapical Surgery: A 3D Imaging Study
NCT ID: NCT06739200
Last Updated: 2024-12-18
Study Results
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Basic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2023-09-04
2024-12-04
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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PRF Membrane Group
Participants in this group will undergo periapical surgery in which a platelet-rich fibrin (PRF) membrane will be placed at the surgical site. The PRF membrane is designed to promote healing and reduce postoperative swelling and pain. Outcomes, including swelling, pain levels, and healing progress, will be evaluated.
Platelet-Rich Fibrin (PRF) Membrane
The Platelet-Rich Fibrin (PRF) membrane is a biocompatible material derived from the participant's own blood and prepared through centrifugation. It is applied at the surgical site during periapical surgery to promote tissue regeneration, enhance wound healing, and reduce postoperative swelling and pain. Unlike synthetic materials, PRF is autologous and does not require additional chemical additives or processing. This study aims to evaluate its effectiveness in improving recovery outcomes compared to surgery without PRF membrane placement.
Control Group
Participants in this group will undergo periapical surgery without the use of a PRF membrane. This group will serve as a comparison to evaluate the effectiveness of the PRF membrane in promoting healing and reducing postoperative swelling and pain. Outcomes, including swelling, pain levels, and healing progress, will be evaluated.
No interventions assigned to this group
Interventions
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Platelet-Rich Fibrin (PRF) Membrane
The Platelet-Rich Fibrin (PRF) membrane is a biocompatible material derived from the participant's own blood and prepared through centrifugation. It is applied at the surgical site during periapical surgery to promote tissue regeneration, enhance wound healing, and reduce postoperative swelling and pain. Unlike synthetic materials, PRF is autologous and does not require additional chemical additives or processing. This study aims to evaluate its effectiveness in improving recovery outcomes compared to surgery without PRF membrane placement.
Eligibility Criteria
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Inclusion Criteria
* 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
* • 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 disease in the surgical area.
* Periodontal probing depths greater than 5 mm.
* Moderate to severe periodontal bone loss.
* Vertical root fractures.
* Perforation of the furcation area or root canal, except for the apical area.
* Smokers or individuals unwilling to refrain from smoking during the study period.
* Participation in another clinical trial within the last 30 days.
* Absolute or relative contraindications for surgery.
18 Years
65 Years
ALL
Yes
Sponsors
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Semmelweis University
OTHER
Responsible Party
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Locations
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Semmelweis University, Department of Oral and Maxillofacial Surgery
Budapest, Mária Utca 52, Hungary
Countries
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References
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Major M, Meszaros B, Wursching T, Polyak M, Kammerhofer G, Nemeth Z, Szabo G, Nagy K. Evaluation of a Structured Light Scanner for 3D Facial Imaging: A Comparative Study with Direct Anthropometry. Sensors (Basel). 2024 Aug 15;24(16):5286. doi: 10.3390/s24165286.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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3736-1/2022/EKU
Identifier Type: -
Identifier Source: org_study_id