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

Semmelweis University

Status: Completed

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

Treatments: Procedure: Platelet-Rich Fibrin (PRF) Membrane

Study type: Interventional

Funder types: Other

Identifiers

NCT06739200

3736-1/2022/EKU

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

20 participants in 2 patient groups

PRF Membrane Group

Experimental group

Description:

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.

Treatment:

Procedure: Platelet-Rich Fibrin (PRF) Membrane

Control Group

No Intervention group

Description:

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.