Tooth LossNCT07011303
Investigation of the Effect of Horizontal Platelet Rich Fibrin Placed in Tooth Extraction Sockets on Bone Formation
A study testing H-PRF and L-PRF in people with Tooth Loss and Dental Implant Failed, run by Tokat Gaziosmanpasa University at 1 site in Turkey (Türkiye).
Trial summary
Dental implants, the treatment of complete and partial edentulous cases involving the restoration of lost teeth, have become a registered and widely used treatment option. Implants: It is an ideal option for the good oral health of the person who has lost his teeth due to periodontal disease, caries, trauma, or any… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth Loss, Dental Implant Failed, Alveolar Bone Loss
- What is being tested?
- H-PRF and L-PRF
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2024to 1 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Volunteer ASA I individuals between the ages of 18-40
- Individuals with indication for tooth extraction
- Patients who want to have implants after tooth extraction
Who cannot join
- Those who are pregnant or lactating
- Those receiving anticoagulant or antiplatelet drug therapy
- Those who received radiotherapy to the head and face area
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Tokat Gaziosmanpasa University, Faculty of Dentistry
Tokat Province, 60100
About this study
Dental implants, the treatment of complete and partial edentulous cases involving the restoration of lost teeth, have become a registered and widely used treatment option. Implants: It is an ideal option for the good oral health of the person who has lost his teeth due to periodontal disease, caries, trauma, or any other reason. When teeth are missing, melting occurs in the jawbone. Following tooth extraction, the loss of the implant and the amount of melting are significantly reduced.
In implant treatments, which have become widely used today, successful results depend on the ideal volume and quality of hard and soft tissues. The amount of bone present in the edentulous area is important for the indication of the implant.
Read more
The aim of this study is to evaluate the histological and immunohistochemical contribution of the H-PRF (horizontal-platelet rich fibrin) material placed in the extraction sockets to the quality of the newly formed bone tissue in order to make successful implants after tooth extractions for various reasons in humans.
The research hypothesis is that H-PRF will contribute positively to the healing of tooth extraction sockets.
Read the detailed description
This study was planned as a prospective, randomized controlled, single-blind clinical study. The study will be conducted on patients applying to the Tokat Gaziosmanpasa University Faculty of Dentistry Oral and Maxillofacial Surgery clinic in the same clinic.
Study inclusion criteria: Volunteer ASA I individuals between the ages of 18-40
Exclusion criteria for the study: Those who are pregnant or lactating Those receiving anticoagulant or antiplatelet drug therapy Those who received radiotherapy to the head and face area Those who are allergic to local anesthetics and prescribed medications
Considering possible losses, a total of 30 volunteers will be included in the study.
Randomization: Before the operation, patients will be divided into three groups: a control group, an L-PRF (leukocyte platelet-rich fibrin) group, and an H-PRF group. The sealed envelope method will be used in the process of assigning patients to the group. Sealed envelopes of the same color will be used for each group, and the patient will not know which group he is assigned to, but the physician will know which group the patient is assigned to.
Tooth extraction will be performed on patients in each group. CBCT (cone beam computed tomography) will be taken immediately afterwards. Soft tissue healing will be evaluated in the first 7 days. CBCT will be taken again after 3 months. Dental implant operations will be performed. Bone tissue biopsies will be taken after the operation. Biopsies are not routine procedures and will be obtained from bone tissue that will be removed during the operation.
Control Group (n=10): Patient group in which no material was placed in the extraction socket after tooth extraction. There will be 10 patients in this group.
L-PRF (Comparison Arm): The patient group in which L-PRF will be placed in the extraction socket after tooth extraction. There will be 10 patients in this group. Patients will be called on the 2nd and 7th days, and their conditions will be evaluated.
H-PRF (Research Branch): The patient group in which H-PRF will be placed in the extraction socket after tooth extraction. There will be 10 patients in this group. Patients will be called on the 2nd and 7th days and their conditions will be evaluated.
- Conditions
- Tooth Loss, Dental Implant Failed, Alveolar Bone Loss
- Being tested
- H-PRF, L-PRF
- Keywords
- H-PRF, L-PRF, tooth extraction
- Medical subject headings
- Tooth Loss, Alveolar Bone Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
H-PRFProcedure or surgery
Blood will be taken from the patient before the surgical procedure is started. The blood sample will be placed in the H-TZF device for centrifugation and the sample will be horizontally centrifuged (2200 RPMx8 min, 700g). After the blood is processed for centrifugation, the surgery will begin. Surgery will be performed under local anesthesia with articaine 2 ml 4% and epinephrine 1:100,000. All patients will be operated by the same surgeon. After local anesthesia is achieved, tooth extraction will be started. After tooth extraction, the surgical field will be washed with sterile 0.9% saline, and H-PRF material will be placed in the area and primarily sutured with a 3.0 silk suture. All patients will be given postoperative instructions by the surgeon. Patients will be prescribed mouthwash (0.12% chlorhexidine mouthwash twice daily for 7 days).
L-PRFProcedure or surgery
Blood will be taken from the patient before the surgical procedure is started. The blood sample will be placed in the L-PRF device for centrifugation and the sample will be centrifuged. (2700M x 12 min, 700g) After the blood is processed for centrifugation, the surgery will begin. Surgery will be performed under local anaesthesia with articaine 2 ml 4% and epinephrine 1:100,000. All patients will be operated by the same surgeon. After local anaesthesia is achieved, tooth extraction will be started. After tooth extraction, the surgical field will be washed with sterile 0.9% saline, and L-PRF material will be placed in the area and primarily sutured with a 3.0 silk suture. All patients will be given postoperative instructions by the surgeon. Patients will be prescribed mouthwash (0.12% chlorhexidine mouthwash twice daily for 7 days).
| Study group | Role | What they receive |
|---|---|---|
| CONTROL GROUP | No intervention | Control Group (n=10): Patient group in which no material was placed in the extraction socket after tooth extraction. |
| L-PRF (leukocyte-platelet rich fibrin) | Active comparator | L-PRF (Comparison Arm): The patient group in which L-PRF will be placed in the extraction socket after tooth extraction. Receives: Procedure: L-PRF |
| H-PRF (horizontal-platelet rich fibrin) | Experimental | H-PRF (Research Branch): The patient group in which H-PRF will be placed in the extraction socket after tooth extraction. Receives: Procedure: H-PRF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum mouth opening measurements
Preoperative and postoperative maximum mouth opening will be measured between the lower and upper middle incisal teeth.
Measured: Preoperative, postoperative 2nd day and 7th day
Pain level after extraction postoperative pain after tooth extraction
Visual Analog Scale (VAS) will be used to assess pain.
Measured: After 6th hour and 7th day (6th hour, 2nd day, 3rd day, 4th day, 5th day, 6th day, 7th day)
Swelling
Preoperative and postoperative edema will be measured according to the reference points.
Measured: Postoperative 2nd and 7th days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2025
- Study start1 Jun 2024
- Primary completion1 Nov 2024
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth LossStudies 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
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tokat Gaziosmanpasa University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, esengul sen, Tokat Gaziosmanpasa University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07011303
- Sponsor's protocol ID
- 23-KAEK-320
- Other IDs
- 2024/25
- Status last verified
- Oct 2026
- First submitted
- 12 Dec 2024
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Horizontal Platelet Rich Fibrin Placed in Tooth Extraction Sockets on Bone Formation
- ClinicalTrials.gov ID
- NCT07011303
- Acronym / sponsor ID
- 23-KAEK-320
- Conditions
- Tooth Loss, Dental Implant Failed, Alveolar Bone Loss
- Keywords
- H-PRF, L-PRF, tooth extraction
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Tokat Gaziosmanpasa UniversityUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 8 Jun 2025 (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.
Dental implants, the treatment of complete and partial edentulous cases involving the restoration of lost teeth, have become a registered and widely used treatment option. Implants: It is an ideal option for the good oral health of the person who has lost his teeth due to periodontal disease, caries, trauma, or any other reason. When teeth are missing, melting occurs in the jawbone. Following tooth extraction, the loss of the implant and the amount of melting are significantly reduced.
In implant treatments, which have become widely used today, successful results depend on the ideal volume and quality of hard and soft tissues. The amount of bone present in the edentulous area is important for the indication of the implant.
The aim of this study is to evaluate the histological and immunohistochemical contribution of the H-PRF (horizontal-platelet rich fibrin) material placed in the extraction sockets to the quality of the newly formed bone tissue in order to make successful implants after tooth extractions for various reasons in humans.
The research hypothesis is that H-PRF will contribute positively to the healing of tooth extraction sockets.
Detailed description
This study was planned as a prospective, randomized controlled, single-blind clinical study. The study will be conducted on patients applying to the Tokat Gaziosmanpasa University Faculty of Dentistry Oral and Maxillofacial Surgery clinic in the same clinic.
Study inclusion criteria: Volunteer ASA I individuals between the ages of 18-40
Exclusion criteria for the study: Those who are pregnant or lactating Those receiving anticoagulant or antiplatelet drug therapy Those who received radiotherapy to the head and face area Those who are allergic to local anesthetics and prescribed medications
Considering possible losses, a total of 30 volunteers will be included in the study.
Randomization: Before the operation, patients will be divided into three groups: a control group, an L-PRF (leukocyte platelet-rich fibrin) group, and an H-PRF group. The sealed envelope method will be used in the process of assigning patients to the group. Sealed envelopes of the same color will be used for each group, and the patient will not know which group he is assigned to, but the physician will know which group the patient is assigned to.
Tooth extraction will be performed on patients in each group. CBCT (cone beam computed tomography) will be taken immediately afterwards. Soft tissue healing will be evaluated in the first 7 days. CBCT will be taken again after 3 months. Dental implant operations will be performed. Bone tissue biopsies will be taken after the operation. Biopsies are not routine procedures and will be obtained from bone tissue that will be removed during the operation.
Control Group (n=10): Patient group in which no material was placed in the extraction socket after tooth extraction. There will be 10 patients in this group.
L-PRF (Comparison Arm): The patient group in which L-PRF will be placed in the extraction socket after tooth extraction. There will be 10 patients in this group. Patients will be called on the 2nd and 7th days, and their conditions will be evaluated.
H-PRF (Research Branch): The patient group in which H-PRF will be placed in the extraction socket after tooth extraction. There will be 10 patients in this group. Patients will be called on the 2nd and 7th days and their conditions will be evaluated.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CONTROL GROUP | No intervention | –Control Group (n=10): Patient group in which no material was placed in the extraction socket after tooth extraction. |
| L-PRF (leukocyte-platelet rich fibrin) | Active comparator | Procedure: L-PRFL-PRF (Comparison Arm): The patient group in which L-PRF will be placed in the extraction socket after tooth extraction. |
| H-PRF (horizontal-platelet rich fibrin) | Experimental | Procedure: H-PRFH-PRF (Research Branch): The patient group in which H-PRF will be placed in the extraction socket after tooth extraction. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Volunteer ASA I individuals between the ages of 18-40
- Individuals with indication for tooth extraction
- Patients who want to have implants after tooth extraction
Key exclusion criteria (3 listed)
- Those who are pregnant or lactating
- Those receiving anticoagulant or antiplatelet drug therapy
- Those who received radiotherapy to the head and face area
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 |
|---|---|---|
| H-PRFBlood will be taken from the patient before the surgical procedure is started. The blood sample will be placed in the H-TZF device for centrifugation and the sample will be horizontally centrifuged (2200 RPMx8 min, 700g). After the blood is processed for centrifugation, the surgery will begin. Surgery will be performed under local anesthesia with articaine 2 ml 4% and epinephrine 1:100,000. All patients will be operated by the same surgeon. After local anesthesia is achieved, tooth extraction will be started. After tooth extraction, the surgical field will be washed with sterile 0.9% saline, and H-PRF material will be placed in the area and primarily sutured with a 3.0 silk suture. All patients will be given postoperative instructions by the surgeon. Patients will be prescribed mouthwash (0.12% chlorhexidine mouthwash twice daily for 7 days). | Procedure or surgery | H-PRF (horizontal-platelet rich fibrin) |
| L-PRFBlood will be taken from the patient before the surgical procedure is started. The blood sample will be placed in the L-PRF device for centrifugation and the sample will be centrifuged. (2700M x 12 min, 700g) After the blood is processed for centrifugation, the surgery will begin. Surgery will be performed under local anaesthesia with articaine 2 ml 4% and epinephrine 1:100,000. All patients will be operated by the same surgeon. After local anaesthesia is achieved, tooth extraction will be started. After tooth extraction, the surgical field will be washed with sterile 0.9% saline, and L-PRF material will be placed in the area and primarily sutured with a 3.0 silk suture. All patients will be given postoperative instructions by the surgeon. Patients will be prescribed mouthwash (0.12% chlorhexidine mouthwash twice daily for 7 days). | Procedure or surgery | L-PRF (leukocyte-platelet rich fibrin) |
Primary outcome
Maximum mouth opening measurements
Time frame: Preoperative, postoperative 2nd day and 7th day
Preoperative and postoperative maximum mouth opening will be measured between the lower and upper middle incisal teeth.
Pain level after extraction postoperative pain after tooth extraction
Time frame: After 6th hour and 7th day (6th hour, 2nd day, 3rd day, 4th day, 5th day, 6th day, 7th day)
Visual Analog Scale (VAS) will be used to assess pain.
Swelling
Time frame: Postoperative 2nd and 7th days
Preoperative and postoperative edema will be measured according to the reference points.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: No
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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.
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 H-PRF and L-PRF in people with Tooth Loss and Dental Implant Failed, run by Tokat Gaziosmanpasa University at 1 site in Turkey (Türkiye).
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 3 inclusion and 3 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: enrolling by invitation, as of the sponsor's last update on 27 Oct 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 Turkey (Türkiye). 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?
This study is still under way. Results are not available in the source record yet.
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?
Maximum mouth opening measurements (time frame: Preoperative, postoperative 2nd day and 7th day). 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?
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 27 Oct 2026.