Dental DiseasesPRFNCT04212767
The Use of PRF in the Management of Soft Tissue Healing
A study testing Alveolar socket preservation with Platelet-rich fibrin in people with Dental Diseases, run by Universidade Federal Fluminense at 1 site in Brazil.
Trial summary
The present study aimed to evaluate the clinical effect of platelet-rich fibrin to improve epithelialization and decrease postoperative pain in post extraction sockets Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dental Diseases
- What is being tested?
- Alveolar socket preservation with Platelet-rich fibrin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteBrazil
- Study dates
- 15 Apr 2017to 15 Nov 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants ≥ 18 years of age;
- Participants needing molar extraction in the mandible or maxilla region.
Who cannot join
- Smokers;
- Pregnant;
- Participants with motor difficulties that impeded or hampered hygien;
- Participants with decompensated metabolic diseases;
- Participants with periodontal disease;
- Participants with history of radiotherapy or use of bisphosphonates.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Dental Clinical Research Center of the Fluminense Federal University
Niterói, Rio de Janeiro, 24020-140
About this study
Official title: The Use of Platelet-rich Fibrin in the Management of Soft Tissue Healing and Pain in Post-extraction Sockets: a Randomized Clinical Trial
The present study aimed to evaluate the clinical effect of platelet-rich fibrin to improve epithelialization and decrease postoperative pain in post extraction sockets
Read the detailed description
Production of PRF membranes A venipuncture was performed, prior of performing any treatment (median basilica vein, median cubital vein, median cephalic vein). Blood was drawn into four sterile, red cover tubes (IntraSpin™, Biohorizons®, Birmingham, Alabama, USA) 10-mL tubes without anticoagulant. The tubes were immediately centrifuged at 2700 rpm for 12 min (~708g) using a vertical/ fixed angle centrifuge (IntraSpin™, Biohorizons®, Birmingham, Alabama, USA). The g-force values were referenced at the bottom of the centrifugation tubes (RCF-max). After centrifugation, each L-PRF clot was removed from the tube and separated from the red element phase at the base with pliers. Four L-PRF clots were squeezed between a sterile metal plate and a metal box to obtain L-PRF membranes, similar in size and thickness.
Surgical procedures and initial clinical measurements The participants underwent periapical radiography or computed tomography (when necessary) and clinical examination to assess the absolute need for dental extraction. The participants underwent initial periodontal treatment, including supra and subgingival scaling, plaque control, and were given oral hygiene instructions.
Before tooth extraction, participants from both groups underwent local anaesthesia with mepivacaine 2% (Mepiadre, Nova DFL, Rio de Janeiro, Brazil). All teeth were extracted using a minimally traumatic procedure. No vertical releasing incisions were performed. To avoid root and bony fractures, the molar teeth were sectioned using a multilaminated drill (Zecrya, Microdont, São Paulo, Brazil). Luxation of the teeth was performed using a periotome followed by removal using forceps. After exodontia, a rigorous inspection and curettage of the socket was performed, followed by irrigation with sterile saline solution (Linhamax, Eurofarma, Rio de Janeiro, Brazil).
The sockets of the test group were filled with two PRF membranes followed by cross suture (Mononylon Ethilon, Johnson \& Johnson, NJ, USA) to stabilize the membranes (Figure 1A), while the sockets of the control group received no type of biomaterial (i.e., left to spontaneous healing).
Postoperative control It was prescribed Ibuprofen (400 mg, Advil, Pfizer, São Paulo, Brazil) every 6 h was also prescribed in case of pain. Mouthwash with chlorhexidine gluconate 0.12% (Periogard, Colgate, São Paulo, Brazil) was also prescribed twice per day for 2 weeks. Sutures were removed after 10 days.
Clinical measurements One and two weeks after extraction, an assessment of soft tissue healing around the sockets was performed using the healing index system described by Landry et al (Landry, 1985). The following parameters were used to assess the level of healing: colour of tissues; epithelialisation of wound margins; presence of bleeding on palpation; granulation; and suppuration. The level of healing was scored as very poor, poor, good, very good, or excellent.
Postoperative pain and number of consumed analgesic tablets were recorded and evaluated. To assess postoperative pain, participants were instructed to complete a 10-unit visual analog scale (VAS) in combination with a graphic rating scale. The VAS ranged from 0 (no pain) to 100 (worst pain imaginable). Questionnaires were collected at the one week follow-up visit.
- Conditions
- Dental Diseases
- Being tested
- Alveolar socket preservation with Platelet-rich fibrin
- Keywords
- Tooth extraction, Platelet-rich fibrin, Soft tissue
- Medical subject headings
- Stomatognathic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alveolar socket preservation with Platelet-rich fibrinProcedure or surgery
Also called Platelet-Rich Fibrin
The sockets of the test group will be filled with two platelet-rich fibrin membranes followed by suture
| Study group | Role | What they receive |
|---|---|---|
| Test group | Experimental | Post-extraction sockets covered with Platelet-Rich Fibrin membrane (n=16) Receives: Procedure: Alveolar socket preservation with Platelet-rich fibrin |
| Control Goroup | No intervention | Post-extraction sockets left to spontaneous healing/clot and primary closure (n=16). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the soft tissue epithelialization speed in post-extraction sockets
One and two weeks after extraction, an assessment of soft tissue healing around the sockets was performed using the healing index system described by Landry et al. The following parameters were used to assess the level of healing: colour of tissues; epithelialisation of wound margins; presence of bleeding on palpation; granulation; and suppuration. The level of healing was scored as very poor, poor, good, very good, or excellent.
Measured: 90 days
Secondary outcomes (2)
Postoperative pain
The participants were instructed to complete a 10-unit visual analog scale (VAS) in combination with a graphic rating scale. The VAS ranged from 0 (no pain) to 100 (worst pain imaginable).
Measured: 90 days
Number of consumed analgesic
Questionnaires were collected at the one week follow-up visit.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2019
- Study start15 Apr 2017
- Primary completion15 Aug 2019
- Study completion15 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Dental DiseasesStudies of the same condition, open and under way.
- 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
- Model description
- Prospective, parallel-arm, randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal Fluminense
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vittorio Moraschini Filho, Universidade Federal Fluminense
- Investigators
- Vittorio Moraschini, PhD, Principal investigator, Fluminense Federal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04212767
- Sponsor's protocol ID
- PRF1
- Acronym
- PRF
- Status last verified
- Dec 2019
- First submitted
- 17 Dec 2019
- Last updated
- 30 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lei L, Yu Y, Han J, Shi D, Sun W, Zhang D, Chen L. Quantification of growth factors in advanced platelet-rich fibrin and concentrated growth factors and their clinical efficacy as adjunctive to the GTR procedure in periodontal intrabony defects. J Periodontol. 2020 Apr;91(4):462-472. doi: 10.1002/JPER.19-0290. Epub 2019 Nov 17.
PubMed 31471902Castro AB, Cortellini S, Temmerman A, Li X, Pinto N, Teughels W, Quirynen M. Characterization of the Leukocyte- and Platelet-Rich Fibrin Block: Release of Growth Factors, Cellular Content, and Structure. Int J Oral Maxillofac Implants. 2019 July/August;34(4):855-864. doi: 10.11607/jomi.7275. Epub 2019 Feb 11.
PubMed 30742137Dohan DM, Choukroun J, Diss A, Dohan SL, Dohan AJ, Mouhyi J, Gogly B. Platelet-rich fibrin (PRF): a second-generation platelet concentrate. Part II: platelet-related biologic features. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2006 Mar;101(3):e45-50. doi: 10.1016/j.tripleo.2005.07.009. Epub 2006 Jan 10.
PubMed 16504850
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Platelet-rich Fibrin in the Management of Soft Tissue Healing and Pain in Post-extraction Sockets: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04212767
- Acronym / sponsor ID
- PRF / PRF1
- Conditions
- Dental Diseases
- Keywords
- Tooth extraction, Platelet-rich fibrin, Soft tissue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Universidade Federal FluminenseUniversity, hospital or other
- Study start
- 15 Apr 2017 (actual)
- Primary completion
- 15 Aug 2019 (actual)
- Study completion
- 15 Nov 2019 (actual)
- First posted
- 30 Dec 2019 (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 present study aimed to evaluate the clinical effect of platelet-rich fibrin to improve epithelialization and decrease postoperative pain in post extraction sockets
Detailed description
Production of PRF membranes A venipuncture was performed, prior of performing any treatment (median basilica vein, median cubital vein, median cephalic vein). Blood was drawn into four sterile, red cover tubes (IntraSpin™, Biohorizons®, Birmingham, Alabama, USA) 10-mL tubes without anticoagulant. The tubes were immediately centrifuged at 2700 rpm for 12 min (~708g) using a vertical/ fixed angle centrifuge (IntraSpin™, Biohorizons®, Birmingham, Alabama, USA). The g-force values were referenced at the bottom of the centrifugation tubes (RCF-max). After centrifugation, each L-PRF clot was removed from the tube and separated from the red element phase at the base with pliers. Four L-PRF clots were squeezed between a sterile metal plate and a metal box to obtain L-PRF membranes, similar in size and thickness.
Surgical procedures and initial clinical measurements The participants underwent periapical radiography or computed tomography (when necessary) and clinical examination to assess the absolute need for dental extraction. The participants underwent initial periodontal treatment, including supra and subgingival scaling, plaque control, and were given oral hygiene instructions.
Before tooth extraction, participants from both groups underwent local anaesthesia with mepivacaine 2% (Mepiadre, Nova DFL, Rio de Janeiro, Brazil). All teeth were extracted using a minimally traumatic procedure. No vertical releasing incisions were performed. To avoid root and bony fractures, the molar teeth were sectioned using a multilaminated drill (Zecrya, Microdont, São Paulo, Brazil). Luxation of the teeth was performed using a periotome followed by removal using forceps. After exodontia, a rigorous inspection and curettage of the socket was performed, followed by irrigation with sterile saline solution (Linhamax, Eurofarma, Rio de Janeiro, Brazil).
The sockets of the test group were filled with two PRF membranes followed by cross suture (Mononylon Ethilon, Johnson \& Johnson, NJ, USA) to stabilize the membranes (Figure 1A), while the sockets of the control group received no type of biomaterial (i.e., left to spontaneous healing).
Postoperative control It was prescribed Ibuprofen (400 mg, Advil, Pfizer, São Paulo, Brazil) every 6 h was also prescribed in case of pain. Mouthwash with chlorhexidine gluconate 0.12% (Periogard, Colgate, São Paulo, Brazil) was also prescribed twice per day for 2 weeks. Sutures were removed after 10 days.
Clinical measurements One and two weeks after extraction, an assessment of soft tissue healing around the sockets was performed using the healing index system described by Landry et al (Landry, 1985). The following parameters were used to assess the level of healing: colour of tissues; epithelialisation of wound margins; presence of bleeding on palpation; granulation; and suppuration. The level of healing was scored as very poor, poor, good, very good, or excellent.
Postoperative pain and number of consumed analgesic tablets were recorded and evaluated. To assess postoperative pain, participants were instructed to complete a 10-unit visual analog scale (VAS) in combination with a graphic rating scale. The VAS ranged from 0 (no pain) to 100 (worst pain imaginable). Questionnaires were collected at the one week follow-up visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, parallel-arm, randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Test group | Experimental | Procedure: Alveolar socket preservation with Platelet-rich fibrinPost-extraction sockets covered with Platelet-Rich Fibrin membrane (n=16) |
| Control Goroup | No intervention | –Post-extraction sockets left to spontaneous healing/clot and primary closure (n=16). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Participants ≥ 18 years of age;
- Participants needing molar extraction in the mandible or maxilla region.
Key exclusion criteria (6 listed)
- Smokers;
- Pregnant;
- Participants with motor difficulties that impeded or hampered hygien;
- Participants with decompensated metabolic diseases;
- Participants with periodontal disease;
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 |
|---|---|---|
| Alveolar socket preservation with Platelet-rich fibrinAlso: Platelet-Rich FibrinThe sockets of the test group will be filled with two platelet-rich fibrin membranes followed by suture | Procedure or surgery | Test group |
Primary outcome
Evaluation of the soft tissue epithelialization speed in post-extraction sockets
Time frame: 90 days
One and two weeks after extraction, an assessment of soft tissue healing around the sockets was performed using the healing index system described by Landry et al. The following parameters were used to assess the level of healing: colour of tissues; epithelialisation of wound margins; presence of bleeding on palpation; granulation; and suppuration. The level of healing was scored as very poor, poor, good, very good, or excellent.
2 secondary outcomes
Postoperative pain
Time frame: 90 days
Number of consumed analgesic
Time frame: 90 days
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 30 Dec 2019.
- Background: PubMed 31471902Lei L, Yu Y, Han J, Shi D, Sun W, Zhang D, Chen L. Quantification of growth factors in advanced platelet-rich fibrin and concentrated growth factors and their clinical efficacy as adjunctive to the GTR procedure in periodontal intrabony defects. J Periodontol. 2020 Apr;91(4):462-472. doi: 10.1002/JPER.19-0290. Epub 2019 Nov 17.
- Background: PubMed 30742137Castro AB, Cortellini S, Temmerman A, Li X, Pinto N, Teughels W, Quirynen M. Characterization of the Leukocyte- and Platelet-Rich Fibrin Block: Release of Growth Factors, Cellular Content, and Structure. Int J Oral Maxillofac Implants. 2019 July/August;34(4):855-864. doi: 10.11607/jomi.7275. Epub 2019 Feb 11.
- Results publication: PubMed 16504850Dohan DM, Choukroun J, Diss A, Dohan SL, Dohan AJ, Mouhyi J, Gogly B. Platelet-rich fibrin (PRF): a second-generation platelet concentrate. Part II: platelet-related biologic features. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2006 Mar;101(3):e45-50. doi: 10.1016/j.tripleo.2005.07.009. Epub 2006 Jan 10.
- Individual participant dataSharing planned: No
Related trials for Dental Diseases
RecruitingPhase 4
Hematological Safety of Dipyrone Versus Paracetamol After Dental Extractions
Hematologic Test, Agranulocytosis
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
Free Soft Tissue Grafts (FSTG) Using Autograft Palatal Donor Tissue vs. Xenograft Collagen Matrix (Zderm™)
Gingival Recession Localized Moderate, Dental Implant
Not yet recruiting
Safety Assessment of Placing a Single Dental Implant Without Antibiotic Prophylaxis in Simple Cases: A Pilot Study
Tooth Loss and Rehabillitation, Dental Implant Failure
Active, not recruiting
L-PRF Block vs Composite Graft for Horizontal Ridge Augmentation
Alveolar Ridge Resorption After Extraction, Alveolar Bone Loss
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.
Vittorio Moraschini, PhD principal investigator
Fluminense Federal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alveolar socket preservation with Platelet-rich fibrin in people with Dental Diseases, run by Universidade Federal Fluminense at 1 site in Brazil.
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 2 inclusion and 6 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 30 Dec 2019. 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 Brazil. 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?
Evaluation of the soft tissue epithelialization speed in post-extraction sockets (time frame: 90 days). 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 NCT04212767, which also lists 3 linked publications.
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 30 Dec 2019.