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Platelet-Rich Fibrin (PRF) vs Bone Graft With Membrane for Ridge Preservation After Tooth Extraction

12. maj 2026 opdateret af: 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:

  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).

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

14

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ja

Beskrivelse

Inclusion Criteria:

  1. Patients of age between 18-80.
  2. Non-smokers or former smokers with at least a 5-year successful cessation history.
  3. 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.
  4. Patients treatment planned for extraction and ridge preservation for at least 2 non-adjacent single-rooted teeth.

Exclusion Criteria:

  1. Current smokers, smokers who have quit <5 years prior to study entry.
  2. Pregnant or lactating women
  3. Patients with substance or alcohol abuse
  4. Patients with a history of antiresorptive therapy, head and neck radiotherapy, and chemotherapy for malignant tumors
  5. Other systemic conditions or medications affecting wound healing.
  6. Poor plaque control with plaque score > 20%
  7. Active/untreated odontogenic and periodontal infections

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Biologisk: Platelet-rich fibrin (PRF)
Autologous platelet concentrate prepared from the participant's blood and applied to the extraction socket, mixed with bone graft.
Enhed: Freeze-dried bone allograft
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.
Enhed: Freeze-dried bone allograft
Human-derived bone graft material used to fill extraction sockets for ridge preservation
Enhed: Collagen barrier membrane
Resorbable membrane placed over the grafted socket to stabilize the graft and prevent soft tissue ingrowth.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in alveolar ridge dimensions
Tidsramme: 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)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Wound healing (re-epithelialization)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Ohio State University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juni 2026

Primær færdiggørelse (Anslået)

1. juni 2027

Studieafslutning (Anslået)

1. juni 2027

Datoer for studieregistrering

Først indsendt

12. maj 2026

Først indsendt, der opfyldte QC-kriterier

12. maj 2026

Først opslået (Faktiske)

19. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

19. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. maj 2026

Sidst verificeret

1. august 2025

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • STUDY20250322

Plan for individuelle deltagerdata (IPD)

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UBESLUTET

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Rod; Knoglebrud

Kliniske forsøg med Platelet-rich fibrin (PRF)

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Sponsorer og samarbejdspartnere

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Betingelser

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Placeringer

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