Evaluation of PRF Membrane in Postoperative Recovery: A Preliminary Study Using 3D Imaging in Periapical Surgery
Phase: NA
Conditions: Periapical Diseases, Radicular Cyst, Granuloma, Postoperative Complications, Pain, Postoperative
Sponsor: Semmelweis University

PRF Membrane and Recovery After Periapical
Surgery: A 3D Imaging Study
PRF Membrane and Recovery After Periapical Surgery: A 3D Imaging Study
Study Unique Protocol ID:
3736-1/2022/EKU
NCT Number:
Not available
Date of Document:
2024-12-11

Aim
Comparisation of the swelling, the quality of life and the post operative pain after endodontic surgery 
with and without of the use of A-PRF+.
Matherials and methods
Patient selection:

10-10 per each group
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:
o
• Uncontrolled diabetes mellitus.
o
• Autoimmune disorders.
o
• Chronic inflammatory diseases.

Pregnant or breastfeeding individuals.

Use of medications or therapies that may interfere with healing, including:
o
• Bisphosphonates.
o
• Immunosuppressants.
o
• Radiotherapy.
o
• 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.
Surgical procedure

If it is required and feasible endodontic treatment or retreatment maximum 1 week before 
surgery

One surgeon perform all operation

Local anaesthesia 2% lidocaine and ephinephrine 3x2 ml lidocaine

Trapezoid submarginal flap (Ochsenbein-Luebke flap)

15 C surgical blade 

Ball shaped 0,27 mm diameter bone burr, 1:1 straight handpiece

3 mm of apical portion is resected- in one piece – perpendicular to the long axis placed in 
sterile saline

3 mm retrograde cavity- with diamond coated ultrasonic instruments

Micorbiological sample 

MTA retrograde RCfilling

Mobilisation of the flap

In the test group the resection cavity was filld and covered with A-PRF+ membrane

Tension free flap closure with 3-0 Silc suture
PRF preparation

In the test group before surgery 3 or 2 (depends on size of the cavity) 10ml glass tubes without
additives

1300 rpm for 8 min centrifugation (Harmonycom)

Using an A-PRF Duo centrifuge (Process for PRF, Nice, France)

Placed in sterile container (PRF Box, Process for PRF, Nice, France)
Postoperative instruction

Diclofecan 50mg (Cataflam 50mg) 2x1 per day, for 3 days

Rinses with 0,12% Chlorehexidine twice a day for 1 week

No postoperatic antibiotics was described

Suture removal after 7 days
Evaluation 

3D optical scans (Einstar, Shining 3D) were recorded over two time period, T0 (preoperative 
scan), T1 (day 3 postoperatively)

VAS (Visula Analogue Scale) pain was graded on a score to 0-10, 0 no pain, 10 maximum 
intesity of pain, for 7 days

Likert scale based questionary: ranging from 0 to 4, 0 non 4 very much, for 7 days daily starts 
ont he operation day 
o
Postoperativ limitations in function: Mouth opening, Chewing, Speaking, Sleeping, 
Daily routine, Work
Statistical Analisys

Statistical Analysis Plan
1. Study Objectives

Primary Objective:
o
To assess the impact of PRF membrane on postoperative swelling and its 
relationship with quality of life dimensions and pain.

Secondary Objectives:
o
To compare quality of life (QoL) dimensions and pain levels pre- and post-
intervention between the PRF membrane group and the control group.
o
To investigate correlations between swelling (volume) and postoperative QoL 
dimensions.
2. Study Design

Type: Preliminary comparative study.

Groups:
o
PRF Membrane Group (10 participants): Underwent apicoectomy with PRF 
membrane application.
o
Control Group (10 participants): Underwent apicoectomy without PRF 
membrane.
3. Outcome Measures
1. Primary Outcomes:
o
Postoperative swelling (volume): Measured using standardized evaluation 
methods.
o
Quality of Life (QoL) dimensions: Assessed using a questionnaire with 
subdimensions (e.g., physical function, pain impact, anxiety, sleep 
disturbance).
2. Secondary Outcomes:
o
Pain intensity: Measured using the Visual Analog Scale (VAS).
o
Correlations between swelling and QoL dimensions.
4. Statistical Methods
1. Descriptive Statistics:
o
Mean ± standard deviation for continuous variables (e.g., QoL scores, pain, 
swelling volume).
o
Frequency and percentage for categorical variables.
2. Normality Testing:
o
Shapiro-Wilk test: Conducted for each variable to determine whether 
parametric or non-parametric tests will be used.
3. Comparative Analyses:

o
Between Groups:

Independent samples t-test for normally distributed data.

Mann-Whitney U test for non-normally distributed data.
o
Within Groups:

Paired t-test for normally distributed pre- and post-intervention 
comparisons.

Wilcoxon signed-rank test for non-normally distributed data.
4. Correlations:
o
Spearman's or Pearson's correlation will be used to evaluate the relationship 
between swelling (volume) and QoL dimensions depending on data 
distribution.
5. Significance Threshold:
o
A two-tailed p-value < 0.05 will be considered statistically significant.
5. Missing Data

Missing data will be handled by:
o
Listwise deletion for analyses where missing data is minimal.
o
Sensitivity analysis if missing data exceeds 10%.
6. Software

All statistical analyses will be performed using SPSS or R software.
7. Reporting

Results will include:
o
Comparative tables of pre- and post-intervention outcomes.
o
Statistical significance levels for group comparisons.
o
Correlation matrices for swelling and QoL dimensions.