PRF Membrane and Recovery After Periapical Surgery: A 3D Imaging Study

Not Applicable

Completed

• Conditions: Periapical Diseases; Radicular Cyst; Granuloma; Postoperative Complications; Pain, Postoperative

• Registration Number: NCT06739200
• Lead Sponsor: Semmelweis University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-04
• Primary Completion: 2024-11-05
• Status Verified: 2024-12
• Study Completion: 2024-12-04
• Study First Submitted: 2024-12-06
• Study First Submitted QC: 2024-12-12
• Last Update Submitted: 2024-12-12
• Study First Posted: 2024-12-18
• Last Update Posted: 2024-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Trial Locations

Locations (1)

Semmelweis University, Department of Oral and Maxillofacial Surgery; 🇭🇺 Budapest, Mária Utca 52, Hungary