Platelet-Rich Fibrin (PRF) vs Bone Graft With Membrane for Ridge Preservation After Tooth Extraction
12 maj 2026 uppdaterad av: Ohio State University
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.
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).
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Beräknad)
14
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Siraj Zabadi, DDS
- Telefonnummer: 614-206-0298
- E-post: Zabadi.1@osu.edu
Studera Kontakt Backup
- Namn: Guo-Liang Cheng, DDS, MS
- E-post: cheng.712@osu.edu
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Ja
Beskrivning
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: PRF-solidified bone graft
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.
|
Autologous platelet concentrate prepared from the participant's blood and applied to the extraction socket, mixed with bone graft.
Human-derived bone graft material used to fill extraction sockets for ridge preservation
|
|
Aktiv komparator: Bone Graft With Collagen Membrane
Extraction socket is grafted with freeze-dried bone allograft (FDBA) and covered with a resorbable collagen membrane for ridge preservation.
|
Human-derived bone graft material used to fill extraction sockets for ridge preservation
Resorbable membrane placed over the grafted socket to stabilize the graft and prevent soft tissue ingrowth.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in alveolar ridge dimensions
Tidsram: 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 months after ridge preservation (prior to implant placement)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Wound healing (re-epithelialization)
Tidsram: 1, 2, 3, and 4 weeks after ridge preservation
|
Soft tissue wound closure over extraction sites will be assessed using serial intraoral scans and analyzed to quantify changes in wound area over time.
|
1, 2, 3, and 4 weeks after ridge preservation
|
|
Percentage of new bone formation
Tidsram: 4 months after ridge preservation (at implant placement)
|
Bone core biopsies obtained at implant placement will be analyzed histologically to determine the percentage of newly formed bone within the grafted sites.
|
4 months after ridge preservation (at implant placement)
|
|
Crestal soft tissue thickness
Tidsram: 4 months after ridge preservation (at implant placement)
|
Soft tissue thickness at the alveolar crest will be measured clinically using a periodontal probe at the time of implant placement.
|
4 months after ridge preservation (at implant placement)
|
|
Postoperative pain score
Tidsram: 1, 2, 3, and 4 weeks after ridge preservation
|
Participant-reported pain will be assessed using a visual analog scale (VAS, 0-100), where higher scores indicate greater pain intensity.
|
1, 2, 3, and 4 weeks after ridge preservation
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
1 juni 2026
Primärt slutförande (Beräknad)
1 juni 2027
Avslutad studie (Beräknad)
1 juni 2027
Studieregistreringsdatum
Först inskickad
12 maj 2026
Först inskickad som uppfyllde QC-kriterierna
12 maj 2026
Första postat (Faktisk)
19 maj 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
19 maj 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
12 maj 2026
Senast verifierad
1 augusti 2025
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- STUDY20250322
Plan för individuella deltagardata (IPD)
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