Platelet-Rich Fibrin (PRF) vs Bone Graft With Membrane for Ridge Preservation After Tooth Extraction
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorOhio State University
About this trial
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:
1. One socket (test side) will get PRF + bone graft (this combination is also called "sticky bone"). 2. 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:
1. How the gums close over the area 2. How much pain you feel 3. How much the bone changes 4. 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).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Platelet-rich fibrin (PRF)
Biological/VaccineAutologous platelet concentrate prepared from the participant's blood and applied to the extraction socket, mixed with bone graft.
Freeze-dried bone allograft
DeviceHuman-derived bone graft material used to fill extraction sockets for ridge preservation
Collagen barrier membrane
DeviceResorbable membrane placed over the grafted socket to stabilize the graft and prevent soft tissue ingrowth.
Treatment groups
14 Participants
are divided into 2 treatment groupsGroup A: PRF-solidified bone graftExperimental treatment 2 interventions
Group B: Bone Graft With Collagen MembraneActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
4 months after ridge preservation (prior to implant placement)Secondary outcomes
1
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.
Time frame
1, 2, 3, and 4 weeks after ridge preservation2
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.
Time frame
4 months after ridge preservation (at implant placement)3
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.
Time frame
4 months after ridge preservation (at implant placement)4
Postoperative pain score
Participant-reported pain will be assessed using a visual analog scale (VAS, 0-100), where higher scores indicate greater pain intensity.
Time frame
1, 2, 3, and 4 weeks after ridge preservationLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: