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

12. mai 2026 oppdatert 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:

  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).

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

14

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske 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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Enhet: 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.
Enhet: Freeze-dried bone allograft
Human-derived bone graft material used to fill extraction sockets for ridge preservation
Enhet: Collagen barrier membrane
Resorbable membrane placed over the grafted socket to stabilize the graft and prevent soft tissue ingrowth.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Ohio State University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. juni 2026

Primær fullføring (Antatt)

1. juni 2027

Studiet fullført (Antatt)

1. juni 2027

Datoer for studieregistrering

Først innsendt

12. mai 2026

Først innsendt som oppfylte QC-kriteriene

12. mai 2026

Først lagt ut (Faktiske)

19. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

19. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

12. mai 2026

Sist bekreftet

1. august 2025

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • STUDY20250322

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