Extraction, ToothNCT07595198
Platelet-Rich Fibrin (PRF) vs Bone Graft With Membrane for Ridge Preservation After Tooth Extraction
A study testing Platelet-rich fibrin (PRF), Freeze-dried bone allograft and Collagen barrier membrane in people with Extraction, Tooth and Tooth Fracture, run by Ohio State University.
Trial summary
This study uses a natural material called Platelet-Rich Fibrin (PRF) to help improve healing after tooth removal. PRF is made from your own blood. A small amount of blood is taken from your arm and spun in a machine to make a thick, sticky layer full of platelets. These platelets help your body heal. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Extraction, Tooth, Tooth Fracture, Tooth Crown Fracture
- What is being tested?
- Platelet-rich fibrin (PRF), Freeze-dried bone allograft and Collagen barrier membrane
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2026to 1 Jun 2027
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients of age between 18-80.
- Non-smokers or former smokers with at least a 5-year successful cessation history.
- Patients with normal systemic health (ASA-I) or well-controlled/stable systemic conditions (ASA-II), such as diabetes with HbA1c < 7.0%, no recent acute myocardial infarction and cerebrovascular accidents within 6 months, or any contraindication for periodontal or implant surgery.
- Patients treatment planned for extraction and ridge preservation for at least 2 non-adjacent single-rooted teeth.
Who cannot join
- Current smokers, smokers who have quit <5 years prior to study entry.
- Pregnant or lactating women
- Patients with substance or alcohol abuse
- Patients with a history of antiresorptive therapy, head and neck radiotherapy, and chemotherapy for malignant tumors
- Other systemic conditions or medications affecting wound healing.
- Poor plaque control with plaque score > 20%
- Active/untreated odontogenic and periodontal infections
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Guo-Liang Cheng, DDS, MS contact
About this study
Official title: Application of Platelet-Rich Fibrin Consolidated Bone Substitutes in Alveolar Ridge Preservation: A Randomized Controlled Study
This study uses a natural material called Platelet-Rich Fibrin (PRF) to help improve healing after tooth removal. PRF is made from your own blood. A small amount of blood is taken from your arm and spun in a machine to make a thick, sticky layer full of platelets. These platelets help your body heal. PRF acts like a "natural bandage" and may help your gums and bone heal faster. Because it comes from your own body, it is safe and lowers the chance of infection or problems.
The goal of this research is to see if adding PRF to a bone graft (used to fill the tooth socket after extraction) can help the area heal faster and grow more new bone.
Read more
If you join this study, it will last about 4 months. You will have two teeth removed, and each socket will get a different treatment:
- One socket (test side) will get PRF + bone graft (this combination is also called "sticky bone").
- The other socket (control side) will get a bone graft + a covering called a barrier membrane (made of collagen).
We will compare how well the two sides heal by looking at:
- How the gums close over the area
- How much pain you feel
- How much the bone changes
- How much new bone grows You will come to the clinic for about 9 visits in total. These visits are part of your regular treatment, along with a few extra steps for the study.
One possible risk is bruising or soreness from the blood draw. If we cannot collect enough blood (about 60-80 ml) because your veins are too small or hard to find, you will not continue in the study, and both sockets will be treated using the control method (bone graft + membrane).
- Being tested
- Platelet-rich fibrin (PRF), Freeze-dried bone allograft, Collagen barrier membrane
- Keywords
- Platelet Rich Fibrin, Extraction, tooth
- Medical subject headings
- Tooth Fractures, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet-rich fibrin (PRF)Biological
Autologous platelet concentrate prepared from the participant's blood and applied to the extraction socket, mixed with bone graft.
Freeze-dried bone allograftDevice
Human-derived bone graft material used to fill extraction sockets for ridge preservation
Collagen barrier membraneDevice
Resorbable membrane placed over the grafted socket to stabilize the graft and prevent soft tissue ingrowth.
| Study group | Role | What they receive |
|---|---|---|
| PRF-solidified bone graft | Experimental | Extraction socket is grafted with freeze-dried bone allograft (FDBA) mixed with autologous platelet-rich fibrin (PRF) to form a cohesive graft, without placement of a barrier membrane. Receives: Biological: Platelet-rich fibrin (PRF); Device: Freeze-dried bone allograft |
| Bone Graft With Collagen Membrane | Active comparator | Extraction socket is grafted with freeze-dried bone allograft (FDBA) and covered with a resorbable collagen membrane for ridge preservation. Receives: Device: Freeze-dried bone allograft; Device: Collagen barrier membrane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in alveolar ridge dimensions
Change in alveolar ridge width and height will be measured by superimposing baseline and 4-month follow-up cone-beam computed tomography (CBCT) images at standardized cross-sectional locations corresponding to the extraction sites.
Measured: 4 months after ridge preservation (prior to implant placement)
Secondary outcomes (4)
Wound healing (re-epithelialization)
Soft tissue wound closure over extraction sites will be assessed using serial intraoral scans and analyzed to quantify changes in wound area over time.
Measured: 1, 2, 3, and 4 weeks after ridge preservation
Percentage of new bone formation
Bone core biopsies obtained at implant placement will be analyzed histologically to determine the percentage of newly formed bone within the grafted sites.
Measured: 4 months after ridge preservation (at implant placement)
Crestal soft tissue thickness
Soft tissue thickness at the alveolar crest will be measured clinically using a periodontal probe at the time of implant placement.
Measured: 4 months after ridge preservation (at implant placement)
Postoperative pain score
Participant-reported pain will be assessed using a visual analog scale (VAS, 0-100), where higher scores indicate greater pain intensity.
Measured: 1, 2, 3, and 4 weeks after ridge preservation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2026
- Study start1 Jun 2026 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extraction, ToothStudies of the same condition, open and under way.
- More trials run by Ohio State 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
- Model description
- This is a randomized split-mouth clinical trial in which each participant receives both interventions at different intraoral sites, allowing for a within-subject comparison
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07595198
- Sponsor's protocol ID
- STUDY20250322
- Status last verified
- Aug 2025
- First submitted
- 12 May 2026
- Last updated
- 19 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Platelet-Rich Fibrin Consolidated Bone Substitutes in Alveolar Ridge Preservation: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07595198
- Acronym / sponsor ID
- STUDY20250322
- Keywords
- Platelet Rich Fibrin, Extraction, tooth
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 19 May 2026 (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.
This study uses a natural material called Platelet-Rich Fibrin (PRF) to help improve healing after tooth removal. PRF is made from your own blood. A small amount of blood is taken from your arm and spun in a machine to make a thick, sticky layer full of platelets. These platelets help your body heal. PRF acts like a "natural bandage" and may help your gums and bone heal faster. Because it comes from your own body, it is safe and lowers the chance of infection or problems.
The goal of this research is to see if adding PRF to a bone graft (used to fill the tooth socket after extraction) can help the area heal faster and grow more new bone.
If you join this study, it will last about 4 months. You will have two teeth removed, and each socket will get a different treatment:
- One socket (test side) will get PRF + bone graft (this combination is also called "sticky bone").
- The other socket (control side) will get a bone graft + a covering called a barrier membrane (made of collagen).
We will compare how well the two sides heal by looking at:
- How the gums close over the area
- How much pain you feel
- How much the bone changes
- How much new bone grows You will come to the clinic for about 9 visits in total. These visits are part of your regular treatment, along with a few extra steps for the study.
One possible risk is bruising or soreness from the blood draw. If we cannot collect enough blood (about 60-80 ml) because your veins are too small or hard to find, you will not continue in the study, and both sockets will be treated using the control method (bone graft + membrane).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- This is a randomized split-mouth clinical trial in which each participant receives both interventions at different intraoral sites, allowing for a within-subject comparison
| Arm | Type | Receives |
|---|---|---|
| PRF-solidified bone graft | Experimental | Biological: Platelet-rich fibrin (PRF), Device: Freeze-dried bone allograftExtraction socket is grafted with freeze-dried bone allograft (FDBA) mixed with autologous platelet-rich fibrin (PRF) to form a cohesive graft, without placement of a barrier membrane. |
| Bone Graft With Collagen Membrane | Active comparator | Device: Freeze-dried bone allograft, Device: Collagen barrier membraneExtraction socket is grafted with freeze-dried bone allograft (FDBA) and covered with a resorbable collagen membrane for ridge preservation. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients of age between 18-80.
- Non-smokers or former smokers with at least a 5-year successful cessation history.
- Patients with normal systemic health (ASA-I) or well-controlled/stable systemic conditions (ASA-II), such as diabetes with HbA1c < 7.0%, no recent acute myocardial infarction and cerebrovascular accidents within 6 months, or any contraindication for periodontal or implant surgery.
- Patients treatment planned for extraction and ridge preservation for at least 2 non-adjacent single-rooted teeth.
Key exclusion criteria (7 listed)
- Current smokers, smokers who have quit <5 years prior to study entry.
- Pregnant or lactating women
- Patients with substance or alcohol abuse
- Patients with a history of antiresorptive therapy, head and neck radiotherapy, and chemotherapy for malignant tumors
- Other systemic conditions or medications affecting wound healing.
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)Autologous platelet concentrate prepared from the participant's blood and applied to the extraction socket, mixed with bone graft. | Biological | PRF-solidified bone graft |
| Freeze-dried bone allograftHuman-derived bone graft material used to fill extraction sockets for ridge preservation | Device | Bone Graft With Collagen Membrane, PRF-solidified bone graft |
| Collagen barrier membraneResorbable membrane placed over the grafted socket to stabilize the graft and prevent soft tissue ingrowth. | Device | Bone Graft With Collagen Membrane |
Primary outcome
Change in alveolar ridge dimensions
Time frame: 4 months after ridge preservation (prior to implant placement)
Change in alveolar ridge width and height will be measured by superimposing baseline and 4-month follow-up cone-beam computed tomography (CBCT) images at standardized cross-sectional locations corresponding to the extraction sites.
4 secondary outcomes
Wound healing (re-epithelialization)
Time frame: 1, 2, 3, and 4 weeks after ridge preservation
Percentage of new bone formation
Time frame: 4 months after ridge preservation (at implant placement)
Crestal soft tissue thickness
Time frame: 4 months after ridge preservation (at implant placement)
Postoperative pain score
Time frame: 1, 2, 3, and 4 weeks after ridge preservation
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 19 May 2026.
- Individual participant dataSharing planned: Undecided
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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.
Guo-Liang Cheng, DDS, MS contact
Questions about this trial
What is this clinical trial studying?
A study testing Platelet-rich fibrin (PRF), Freeze-dried bone allograft and Collagen barrier membrane in people with Extraction, Tooth and Tooth Fracture, run by Ohio State University.
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 7 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: opening soon, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Siraj Zabadi, DDS (614-206-0298, Zabadi.1@osu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in alveolar ridge dimensions (time frame: 4 months after ridge preservation (prior to implant placement)). 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 19 May 2026.