Evaluation of PRF Membrane in Postoperative Recovery: A Preliminary Study Using 3D Imaging in Periapical Surgery
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Periapical Diseases
- Sponsor
- Semmelweis University
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Change in Quality of Life (QoL) Using the PROMIS-29+2 Profile v2.1
- Status
- Completed
- Last Updated
- last year
Overview
Brief 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.
Investigators
Eligibility Criteria
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.
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).
Outcomes
Primary Outcomes
Change in Quality of Life (QoL) Using the PROMIS-29+2 Profile v2.1
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).
Change in Pain Intensity Using the Visual Analog Scale (VAS)
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).
Change in Postoperative Swelling Using 3D Optical Scans
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).