Clinical trial NCT06739200: PRF Membrane and Recovery After Periapical Surgery: A 3D Imaging Study
Official title: Evaluation of PRF Membrane in Postoperative Recovery: A Preliminary Study Using 3D Imaging in Periapical Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periapical Diseases
Radicular Cyst
Granuloma
Postoperative Complications
Pain, Postoperative
Lead sponsor: Semmelweis University
Sponsor class: OTHER
First posted: 2024-12-18
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.
* 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.

Primary outcomes:
measure: Change in Quality of Life (QoL) Using the PROMIS-29+2 Profile v2.1
timeFrame: Preoperative and Day 7 postoperative.
measure: Change in Pain Intensity Using the Visual Analog Scale (VAS)
timeFrame: Daily assessments from Day 0 (day of surgery) to Day 7 postoperative.
measure: Change in Postoperative Swelling Using 3D Optical Scans
timeFrame: Measurements were taken at T0 (preoperative) and T1 (Day 3 postoperative).
Secondary outcomes:
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: Semmelweis University, Department of Oral and Maxillofacial Surgery
state: Mária Utca 52
Study officials:
References:
citation: 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.