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

December 12, 2024 updated by: Semmelweis University

Evaluation of PRF Membrane in Postoperative Recovery: A Preliminary Study Using 3D Imaging in Periapical Surgery

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hungary
    • Mária Utca 52
      • Budapest, Mária Utca 52, Hungary, 1085
        • Semmelweis University, Department of Oral and Maxillofacial Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Procedure: 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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Preoperative and Day 7 postoperative.
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).
Daily assessments from Day 0 (day of surgery) to Day 7 postoperative.
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).
Measurements were taken at T0 (preoperative) and T1 (Day 3 postoperative).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Semmelweis University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 4, 2023

Primary Completion (Actual)

November 5, 2024

Study Completion (Actual)

December 4, 2024

Study Registration Dates

First Submitted

December 6, 2024

First Submitted That Met QC Criteria

December 12, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 12, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3736-1/2022/EKU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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