Alveolar Socket PreservationNCT02300246
Clinical, Histological and Micro-computed Tomographic Evaluation of Neoformed Tissue in Post-extraction Sockets Covered With Platelet-rich Fibrin (PRF) Membrane: a Randomized Controlled Trial
A study testing Platelet-Rich Fibrin in people with Alveolar Socket Preservation, run by Marcos de Oliveira Barceleiro at 1 site in Brazil.
Trial summary
The platelet-rich fibrin (PRF), belongs to a new generation of plasma concentrate with biomechanical processing simplified and without the need for handling blood biochemistry. Some studies have shown the potential of PRF in release growth factors assisting and accelerating the regeneration of soft tissues, however… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alveolar Socket Preservation
- What is being tested?
- Platelet-Rich Fibrin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jul 2014to 1 Dec 2014
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients aged over 18 years
- Healthy patients with indication for dental extraction
- Teeth adjacent to the extraction site
- Patients willing to cooperate with the study and who have signed the informed consent form.
Who cannot join
- Patients showing periapical or periodontal infection
- Patients with severe systemic diseases
- Patients on medications such as chemotherapy, anticoagulants, corticosteroids, biphosphonates and drugs imunossupressivas
- Patients who have chronic diseases decompensated (e.g. hypertension, diabetes, rheumatic diseases, renal, and hepatic)
- Patients with bone diseases, metabolic (osteomalacia, hypocalcemia and hypercalcemia).
Trial locations and contacts
1 site in 1 country.
About this study
The platelet-rich fibrin (PRF), belongs to a new generation of plasma concentrate with biomechanical processing simplified and without the need for handling blood biochemistry. Some studies have shown the potential of PRF in release growth factors assisting and accelerating the regeneration of soft tissues, however with contradictory results regarding the hard tissues. The aim of this study will be to evaluate through clinical analyzes, histomorphometric and micro-computed tomographic images, the dimensional changes, the quantity and the quality of the tissues formed socket after extractions that receive membranes of PRF. 15 sockets (test group) will receive a membrane of PRF after extraction and the other 15 (control group) received no biomaterial (spontaneous healing).
Read the detailed description
- Development methodology This study will be a randomized controlled and will be conducted according to the principles outlined in the Declaration of Helsinki regarding experiments on human beings. This work was submitted to the Ethics Committee, with the approval number: CAAE: 21317113.4.0000.5243. To ensure the quality of this randomized study, guidelines RCT-CONSORT checklist will be followed.
- Selection of volunteers / sample The sample will consist of 30 human alveolar socket. Selected volunteers must agree to participate in the study signed an informed consent form and being willing to follow the guidelines and proposed timelines. The volunteers will be treated at the Dental Clinical Research Center of the Fluminense Federal University. The 30 teeth involved in this study should provide an indication of tooth extraction without treatment possibilities, determined by clinical and radiological examination.
- Pre-Surgical Treatment Dental and medical case histories will be conducted on all volunteers. Initially, volunteers will be selected and diagnosed by clinical examination and periapical radiographic or cone beam tomographic to assess the need for tooth extraction. All volunteers will undergo basic periodontal therapy and oral hygiene instructions. Volunteers who have a risk factor for bacterial endocarditis will be medicated with Amoxicillin 2g single dose one hour before the procedure, and for those allergic to penicillin, will be prescribed 600g single dose of clindamycin one hour before procedure, as recommended by the American College of Cardiology. Laboratory tests, including blood pressure measurement, complete blood count, lipid profile, coagulation profile and complete fasting glucose will be required for all volunteers.
- Surgical Procedures Plaster study models are made by molding with alginate in all volunteers, to enable construction of the measuring guides (templates) in acrylic. Also intraoral photographs will be held. Volunteers will undergo local anesthesia (2% with epinephrine Mepvacaína - 1: 100.00) for extraction of teeth. In all cases, the extractions will be performed in a minimally traumatic manner and without lifting flap with the aim of preservation tissues. Incisions intra-sulculares the free surfaces (buccal / lingual) and proximal (mesial / distal) will be performed with a scalpel blade 15C aiming the disruption of the periodontal fibers. The dislocation of the tooth will be conducted with a forceps, with subsequent removal of the tooth socket. After extraction, a rigorous inspection and curettage of the socket for the removal of granulation tissue will be held, followed by irrigation with sterile saline. Performed after extraction, will start to make themselves venous blood of volunteers himself for a qualified professional with the goal of achieving the PRF membrane. For this, will be collected with a sterile without anti-coagulant about 10 ml of blood from the median cubital vein (arm) syringe. It will be led immediately into a test tube and centrifuge for which will be calibrated to 2700 rpm for 12 minutes. After processing, three phases are arranged within a test tube. The fibrin clot is obtained between the layers of acellular layer of plasma and red blood cells. The same tube is carefully collected and manipulated to form a membrane which is sutured with 5.0 absorbable synthetic yarn (Vycril - Johnson \& Johnson). The sutures are removed seven days after the procedure. The remaining fifteen sockets (control group) are not filled with any biomaterial (only clot). Volunteers will be instructed to rinse their mouths twice daily for 15 days with chlorhexidine gluconate 0.12%. Queries review will be conducted in the first week for suture removal and the subsequent second and fifth weeks.
- Clinical Evaluation Prior to the extraction of both groups, the bands of keratinized gingiva buccal and lingual measures are the muco-gingival line to the gingival margin, with support from the UNC-15 periodontal probe, positioned on a template (stent ) acrylic resin. Furthermore, measurements of the gingival margin of the template, track keratinized gingiva and the measurement from the edge of the template edge bony ridge will be held in the regions mesial, buccal and distal of the buccal and lingual surfaces. For the evaluation of the thickness of the tissues, a surgical caliper located at 5mm from the gingival margin is used. The data collected will be immediately recorded by an assistant. Clinical evaluations will be performed prior to extraction (T1) and 120 days (T2).
- Histomorphometric analysis At T2, an implant will be installed in the socket region. The surgical bone obtained during the discharge procedure for implant placement through a trephine measuring about 3mm in diameter, will be collected. It will be stored in buffered formaldehyde, decalcified in EDTA, dehydrated in ethanol and embedded in paraffin. Serial sections including the central portion of the bone cylinder will be prepared parallel to the long axis, with the standard microtome in 5mm. The sections are stained with hematoxylin and eosin. The analysis of the new tissue formed is evaluated in Leitz microscope equipped with image capture system. Morphometric measurements are evaluated to determine the proportion occupied by mineralized bone (lamellar bone, immature bone), osteoid tissue (connective tissue matrix rich in collagen and partially mineralized), bone marrow (adipocytes and vascular structures), fibrous tissue and tissue residual (tissue elements unidentified artifacts of preparation).
- Micro-computed tomographics Representative non-decalcified samples will be scanned at a resolution of 18 x 18 x 18 voxels μc3 using a micro-Pxs5-928EA cone beam CT. The GEHC MicroView Plus ® Analysis software (GE Healthcare), will be used to create three-dimensional reconstructions (3D) bone tissue from the scan. The tissue to be analyzed is represented by all or fragments of tissue biopsy samples. The value scale in grayscale will be used in each biopsy by a single calibrated examiner and anonymous. The value of the average grayscale will be calculated and used as the representative to evaluate bone volume (BV) and the mineral content of the tissue value. The tissue mineral density will also be calculated.
- Statistical analysis The results express the mean ± 95% CI. Mann-Whitney tests will be conducted. Will be considered as significant differences when P < 0.05. Nominal data will be evaluated by chi-square test. Alternatively, in case of no associates (extreme) values, the Fisher exact test will be used. Continuous variables are expressed as mean and standard deviation and analyzed for normal distribution using the Shapiro-Wilk test. The Student t or Mann-Whitney tests will be applied for normal and non-normal distribution, respectively.
- Conditions
- Alveolar Socket Preservation
- Being tested
- Platelet-Rich Fibrin
- Keywords
- alveolar socket preservation, tooth extraction, platelet concentrates, growth factors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet-Rich FibrinProcedure or surgery
Alveolar socket preservation with Platelet-Rich Plasma
| Study group | Role | What they receive |
|---|---|---|
| Test Group | Experimental | Alveolar socket post-extraction covered with PRF Receives: Procedure: Platelet-Rich Fibrin |
| Control Group | No intervention | Only clot (spontaneous healing) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dimensional changes of the alveolar crest.
Clinical examination, histological and micro-computed tomography analyses will be conducted.
Measured: 120 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2014 (estimated)
- Study start1 Jul 2014
- Primary completion1 Dec 2014
- Study completion1 Dec 2014
Why it stopped: Researcher didn't start the study. Didn't receive funds.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Alveolar Socket PreservationStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marcos de Oliveira Barceleiro
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Marcos de Oliveira Barceleiro, Universidade Federal Fluminense
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02300246
- Sponsor's protocol ID
- UFederalFluminense
- Status last verified
- May 2026
- First submitted
- 20 Nov 2014
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Farina R, Bressan E, Taut A, Cucchi A, Trombelli L. Plasma rich in growth factors in human extraction sockets: a radiographic and histomorphometric study on early bone deposition. Clin Oral Implants Res. 2013 Dec;24(12):1360-8. doi: 10.1111/clr.12033. Epub 2012 Sep 24.
PubMed 22998461Suttapreyasri S, Leepong N. Influence of platelet-rich fibrin on alveolar ridge preservation. J Craniofac Surg. 2013 Jul;24(4):1088-94. doi: 10.1097/SCS.0b013e31828b6dc3.
PubMed 23851746Alissa R, Esposito M, Horner K, Oliver R. The influence of platelet-rich plasma on the healing of extraction sockets: an explorative randomised clinical trial. Eur J Oral Implantol. 2010 Summer;3(2):121-34.
PubMed 20623037Hauser F, Gaydarov N, Badoud I, Vazquez L, Bernard JP, Ammann P. Clinical and histological evaluation of postextraction platelet-rich fibrin socket filling: a prospective randomized controlled study. Implant Dent. 2013 Jun;22(3):295-303. doi: 10.1097/ID.0b013e3182906eb3.
PubMed 23644909
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical, Histological and Micro-computed Tomographic Evaluation of Neoformed Tissue in Post-extraction Sockets Covered With Platelet-rich Fibrin (PRF) Membrane: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02300246
- Acronym / sponsor ID
- UFederalFluminense
- Conditions
- Alveolar Socket Preservation
- Keywords
- alveolar socket preservation, tooth extraction, platelet concentrates, growth factors
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Researcher didn't start the study. Didn't receive funds.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Marcos de Oliveira BarceleiroUniversity, hospital or other
- Study start
- 1 Jul 2014 (actual)
- Primary completion
- 1 Dec 2014 (actual)
- Study completion
- 1 Dec 2014 (actual)
- First posted
- 24 Nov 2014 (estimated)
- 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 platelet-rich fibrin (PRF), belongs to a new generation of plasma concentrate with biomechanical processing simplified and without the need for handling blood biochemistry. Some studies have shown the potential of PRF in release growth factors assisting and accelerating the regeneration of soft tissues, however with contradictory results regarding the hard tissues. The aim of this study will be to evaluate through clinical analyzes, histomorphometric and micro-computed tomographic images, the dimensional changes, the quantity and the quality of the tissues formed socket after extractions that receive membranes of PRF. 15 sockets (test group) will receive a membrane of PRF after extraction and the other 15 (control group) received no biomaterial (spontaneous healing).
Detailed description
- Development methodology This study will be a randomized controlled and will be conducted according to the principles outlined in the Declaration of Helsinki regarding experiments on human beings. This work was submitted to the Ethics Committee, with the approval number: CAAE: 21317113.4.0000.5243. To ensure the quality of this randomized study, guidelines RCT-CONSORT checklist will be followed.
- Selection of volunteers / sample The sample will consist of 30 human alveolar socket. Selected volunteers must agree to participate in the study signed an informed consent form and being willing to follow the guidelines and proposed timelines. The volunteers will be treated at the Dental Clinical Research Center of the Fluminense Federal University. The 30 teeth involved in this study should provide an indication of tooth extraction without treatment possibilities, determined by clinical and radiological examination.
- Pre-Surgical Treatment Dental and medical case histories will be conducted on all volunteers. Initially, volunteers will be selected and diagnosed by clinical examination and periapical radiographic or cone beam tomographic to assess the need for tooth extraction. All volunteers will undergo basic periodontal therapy and oral hygiene instructions. Volunteers who have a risk factor for bacterial endocarditis will be medicated with Amoxicillin 2g single dose one hour before the procedure, and for those allergic to penicillin, will be prescribed 600g single dose of clindamycin one hour before procedure, as recommended by the American College of Cardiology. Laboratory tests, including blood pressure measurement, complete blood count, lipid profile, coagulation profile and complete fasting glucose will be required for all volunteers.
- Surgical Procedures Plaster study models are made by molding with alginate in all volunteers, to enable construction of the measuring guides (templates) in acrylic. Also intraoral photographs will be held. Volunteers will undergo local anesthesia (2% with epinephrine Mepvacaína - 1: 100.00) for extraction of teeth. In all cases, the extractions will be performed in a minimally traumatic manner and without lifting flap with the aim of preservation tissues. Incisions intra-sulculares the free surfaces (buccal / lingual) and proximal (mesial / distal) will be performed with a scalpel blade 15C aiming the disruption of the periodontal fibers. The dislocation of the tooth will be conducted with a forceps, with subsequent removal of the tooth socket. After extraction, a rigorous inspection and curettage of the socket for the removal of granulation tissue will be held, followed by irrigation with sterile saline. Performed after extraction, will start to make themselves venous blood of volunteers himself for a qualified professional with the goal of achieving the PRF membrane. For this, will be collected with a sterile without anti-coagulant about 10 ml of blood from the median cubital vein (arm) syringe. It will be led immediately into a test tube and centrifuge for which will be calibrated to 2700 rpm for 12 minutes. After processing, three phases are arranged within a test tube. The fibrin clot is obtained between the layers of acellular layer of plasma and red blood cells. The same tube is carefully collected and manipulated to form a membrane which is sutured with 5.0 absorbable synthetic yarn (Vycril - Johnson \& Johnson). The sutures are removed seven days after the procedure. The remaining fifteen sockets (control group) are not filled with any biomaterial (only clot). Volunteers will be instructed to rinse their mouths twice daily for 15 days with chlorhexidine gluconate 0.12%. Queries review will be conducted in the first week for suture removal and the subsequent second and fifth weeks.
- Clinical Evaluation Prior to the extraction of both groups, the bands of keratinized gingiva buccal and lingual measures are the muco-gingival line to the gingival margin, with support from the UNC-15 periodontal probe, positioned on a template (stent ) acrylic resin. Furthermore, measurements of the gingival margin of the template, track keratinized gingiva and the measurement from the edge of the template edge bony ridge will be held in the regions mesial, buccal and distal of the buccal and lingual surfaces. For the evaluation of the thickness of the tissues, a surgical caliper located at 5mm from the gingival margin is used. The data collected will be immediately recorded by an assistant. Clinical evaluations will be performed prior to extraction (T1) and 120 days (T2).
- Histomorphometric analysis At T2, an implant will be installed in the socket region. The surgical bone obtained during the discharge procedure for implant placement through a trephine measuring about 3mm in diameter, will be collected. It will be stored in buffered formaldehyde, decalcified in EDTA, dehydrated in ethanol and embedded in paraffin. Serial sections including the central portion of the bone cylinder will be prepared parallel to the long axis, with the standard microtome in 5mm. The sections are stained with hematoxylin and eosin. The analysis of the new tissue formed is evaluated in Leitz microscope equipped with image capture system. Morphometric measurements are evaluated to determine the proportion occupied by mineralized bone (lamellar bone, immature bone), osteoid tissue (connective tissue matrix rich in collagen and partially mineralized), bone marrow (adipocytes and vascular structures), fibrous tissue and tissue residual (tissue elements unidentified artifacts of preparation).
- Micro-computed tomographics Representative non-decalcified samples will be scanned at a resolution of 18 x 18 x 18 voxels μc3 using a micro-Pxs5-928EA cone beam CT. The GEHC MicroView Plus ® Analysis software (GE Healthcare), will be used to create three-dimensional reconstructions (3D) bone tissue from the scan. The tissue to be analyzed is represented by all or fragments of tissue biopsy samples. The value scale in grayscale will be used in each biopsy by a single calibrated examiner and anonymous. The value of the average grayscale will be calculated and used as the representative to evaluate bone volume (BV) and the mineral content of the tissue value. The tissue mineral density will also be calculated.
- Statistical analysis The results express the mean ± 95% CI. Mann-Whitney tests will be conducted. Will be considered as significant differences when P < 0.05. Nominal data will be evaluated by chi-square test. Alternatively, in case of no associates (extreme) values, the Fisher exact test will be used. Continuous variables are expressed as mean and standard deviation and analyzed for normal distribution using the Shapiro-Wilk test. The Student t or Mann-Whitney tests will be applied for normal and non-normal distribution, respectively.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Group | Experimental | Procedure: Platelet-Rich FibrinAlveolar socket post-extraction covered with PRF |
| Control Group | No intervention | –Only clot (spontaneous healing) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged over 18 years
- Healthy patients with indication for dental extraction
- Teeth adjacent to the extraction site
- Patients willing to cooperate with the study and who have signed the informed consent form.
Key exclusion criteria (5 listed)
- Patients showing periapical or periodontal infection
- Patients with severe systemic diseases
- Patients on medications such as chemotherapy, anticoagulants, corticosteroids, biphosphonates and drugs imunossupressivas
- Patients who have chronic diseases decompensated (e.g. hypertension, diabetes, rheumatic diseases, renal, and hepatic)
- Patients with bone diseases, metabolic (osteomalacia, hypocalcemia and hypercalcemia).
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 FibrinAlveolar socket preservation with Platelet-Rich Plasma | Procedure or surgery | Test Group |
Primary outcome
Dimensional changes of the alveolar crest.
Time frame: 120 days
Clinical examination, histological and micro-computed tomography analyses will be conducted.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Background: PubMed 22998461Farina R, Bressan E, Taut A, Cucchi A, Trombelli L. Plasma rich in growth factors in human extraction sockets: a radiographic and histomorphometric study on early bone deposition. Clin Oral Implants Res. 2013 Dec;24(12):1360-8. doi: 10.1111/clr.12033. Epub 2012 Sep 24.
- Background: PubMed 23851746Suttapreyasri S, Leepong N. Influence of platelet-rich fibrin on alveolar ridge preservation. J Craniofac Surg. 2013 Jul;24(4):1088-94. doi: 10.1097/SCS.0b013e31828b6dc3.
- Background: PubMed 20623037Alissa R, Esposito M, Horner K, Oliver R. The influence of platelet-rich plasma on the healing of extraction sockets: an explorative randomised clinical trial. Eur J Oral Implantol. 2010 Summer;3(2):121-34.
- Results publication: PubMed 23644909Hauser F, Gaydarov N, Badoud I, Vazquez L, Bernard JP, Ammann P. Clinical and histological evaluation of postextraction platelet-rich fibrin socket filling: a prospective randomized controlled study. Implant Dent. 2013 Jun;22(3):295-303. doi: 10.1097/ID.0b013e3182906eb3.
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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 in people with Alveolar Socket Preservation, run by Marcos de Oliveira Barceleiro 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 4 inclusion and 5 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: withdrawn, as of the sponsor's last update on 15 May 2026. 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 was withdrawn before enrolling participants, so there are no results.
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?
Dimensional changes of the alveolar crest. (time frame: 120 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 NCT02300246, which also lists 4 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 15 May 2026.