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

NCT06739200 | Completed

• 1 other identifier: 3736-1/2022/EKU
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Periapical Diseases; Radicular Cyst; Granuloma; Postoperative Complications; Pain, Postoperative

Outcome Measures

Primary Outcomes (3)

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

  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)

  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

  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).

Study Arms (2)

PRF Membrane Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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.

Interventions

Platelet-Rich Fibrin (PRF) Membrane PROCEDURE

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.

PRF Membrane Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Semmelweis University: lead

Study Sites (1)

Semmelweis University, Department of Oral and Maxillofacial Surgery

Budapest, Mária Utca 52, 1085, Hungary

Location

Related Publications (1)

• 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.

  PMID: 39204985 RESULT

MeSH Terms

Conditions

Periapical Diseases; Radicular Cyst; Granuloma; Postoperative Complications; Pain, Postoperative

Interventions

Prolactin-Releasing Hormone

Condition Hierarchy (Ancestors)

Jaw Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontal Cyst; Odontogenic Cysts; Jaw Cysts; Bone Cysts; Cysts; Neoplasms; Musculoskeletal Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2024
• First Posted: December 18, 2024
• Study Start: September 4, 2023
• Primary Completion: November 5, 2024
• Study Completion: December 4, 2024
• Last Updated: December 18, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

HU (1)