Periapical DiseasesNCT06739200
PRF Membrane and Recovery After Periapical Surgery: A 3D Imaging Study
A study testing Platelet-Rich Fibrin (PRF) Membrane in people with Periapical Diseases and Radicular Cyst, run by Semmelweis University at 1 site in Hungary.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Periapical Diseases, Radicular Cyst, Granuloma
- What is being tested?
- Platelet-Rich Fibrin (PRF) Membrane
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteHungary
- Study dates
- 4 Sep 2023to 4 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Show all 12Show fewer
- 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.
Who cannot join
- 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:
Show all 21Show fewer
- • 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 locations and contacts
1 site in 1 country.
Hungary1 site
Semmelweis University, Department of Oral and Maxillofacial Surgery
Budapest, Mária Utca 52, 1085
About this study
Official title: 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.
Read more
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
- Being tested
- Platelet-Rich Fibrin (PRF) Membrane
- Medical subject headings
- Periapical Diseases, Radicular Cyst, Granuloma, Postoperative Complications, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet-Rich Fibrin (PRF) MembraneProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: Measurements were taken at T0 (preoperative) and T1 (Day 3 postoperative).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2024
- Study start4 Sep 2023
- Primary completion5 Nov 2024
- Study completion4 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Periapical DiseasesStudies of the same condition, open and under way.
- More trials run by Semmelweis UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Semmelweis University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06739200
- Sponsor's protocol ID
- 3736-1/2022/EKU
- Status last verified
- Dec 2024
- First submitted
- 6 Dec 2024
- Last updated
- 18 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39204985
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of PRF Membrane in Postoperative Recovery: A Preliminary Study Using 3D Imaging in Periapical Surgery
- ClinicalTrials.gov ID
- NCT06739200
- Acronym / sponsor ID
- 3736-1/2022/EKU
- Conditions
- Periapical Diseases, Radicular Cyst, Granuloma, Postoperative Complications, Pain, Postoperative
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Semmelweis UniversityUniversity, hospital or other
- Study start
- 4 Sep 2023 (actual)
- Primary completion
- 5 Nov 2024 (actual)
- Study completion
- 4 Dec 2024 (actual)
- First posted
- 18 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRF Membrane Group | Experimental | Procedure: Platelet-Rich Fibrin (PRF) MembraneParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (21 listed)
- Patients with systemic conditions affecting healing, such as:
- Pregnant or breastfeeding individuals.
- Use of medications or therapies that may interfere with healing, including:
- Requires antibiotic prophylaxis or therapy.
- History of allergies or adverse reactions to blood-derived products.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Platelet-Rich Fibrin (PRF) MembraneThe 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. | Procedure or surgery | PRF Membrane Group |
Primary outcome
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).
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).
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2024.
- Results publication: PubMed 39204985Major 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.
- Individual participant dataSharing planned: No
Related trials for Periapical Diseases
Recruiting
Effects of Different Activation Techniques on Antimicrobial Photodynamic Therapy in Apical Periodontitis
Apical Periodontitis, Endodontic Retreatment
Not yet recruiting
Post-operative Pain and Clinical Outcome After Single-cone Obturation With a Calcium Silicate-based Versus Epoxy Resin Sealer
Post Operative Pain, Acute, Irreversible Pulpitis (Toothache)
Not yet recruiting
PRP-Assisted Regenerative Endodontics Versus Conventional Root Canal Treatment in Mature Necrotic Teeth
Pulp Necrosis, Apical Periodontitis
Not yet recruiting
Clinical and Inflammatory Outcomes of Regenerative Endodontic Treatment Using Injectable Platelet-Rich Fibrin in Mature Necrotic Teeth With Chronic Apical Periodontitis.
Chronic Apical Periodontitis, Pulp Necrosis
Active, not recruiting
Early Healing of Apical Periodontitis After Root Canal Treatment With Bioceramic and Calcium Hydroxide Medicaments: Evaluation Using PAI and ImageJ
Apical Periodontitis, Root Canal Treatment
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Platelet-Rich Fibrin (PRF) Membrane in people with Periapical Diseases and Radicular Cyst, run by Semmelweis University at 1 site in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Quality of Life (QoL) Using the PROMIS-29+2 Profile v2.1 (time frame: Preoperative and Day 7 postoperative.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06739200, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2024.