Semmelweis University, Department of Oral and Maxillofacial Surgery
Budapest, Mária Utca 52, 1085, Hungary
NCT Number: NCT06739200
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.
Looking for future studies?
Notify Me18 year–65 year
All sexes
Interventional
Not applicable
Budapest, Mária Utca 52, 1085, Hungary
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Preoperative and Day 7 postoperative.
Quality of life (QoL) was evaluated using the Patient-Reported Outcomes Measurement Information System (PROMIS) 29+2 Profile v2.1 questionnaire, a validated tool assessing health-related QoL across multiple domains, including physical function, emotional stress, sleep disturbance, and social tasks. Each domain is scored using a standardized T-score scale, ranging from 20 (lowest) to 80 (highest), where higher scores indicate better quality of life.
Time Points: Preoperative and Day 7 postoperative.
Unit of Measure: PROMIS T-score (range: 20-80).
Time frame: Daily assessments from Day 0 (day of surgery) to Day 7 postoperative.
Pain intensity was measured daily using the Visual Analog Scale (VAS), a validated tool for assessing patient-reported pain. The VAS scale ranges from 0 (no pain) to 10 (worst possible pain), where higher scores indicate worse pain outcomes. Measurements were taken daily for seven days following surgery.
Time Points: Daily from Day 0 (day of surgery) to Day 7 postoperative.
Unit of Measure: Scale Points (range: 0-10).
Time frame: Measurements were taken at T0 (preoperative) and T1 (Day 3 postoperative).
Postoperative swelling was measured volumetrically using 3D optical scans performed with the Einstar 3D scanner (Shining 3D, Hangzhou, China). Measurements were taken preoperatively (T0) and on Day 3 postoperative (T1). Swelling volume is expressed in cubic centimeters (cm³), where a higher volume indicates greater swelling.
Time Points: Preoperative (T0) and Day 3 postoperative (T1).
Unit of Measure: Cubic centimeters (cm³).
Semmelweis University
Other
Evaluation of PRF Membrane in Postoperative Recovery: A Preliminary Study Using 3D Imaging in Periapical Surgery
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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