Diese Seite wurde automatisch übersetzt und die Genauigkeit der Übersetzung wird nicht garantiert. Bitte wende dich an die englische Version für einen Quelltext.

Titanium-Prepared Platelet-Rich Fibrin for Extraction Socket Healing (TPRF-SOCKET)

14. Juli 2026 aktualisiert von: Hakan özdemir, Eskisehir Osmangazi University

Effect of Titanium-Prepared Platelet-Rich Fibrin on Extraction Socket Healing: A Randomized Clinical Trial Using CBCT-Based Volumetric Analysis

Alveolar ridge preservation after tooth extraction is important for maintaining bone volume and facilitating future implant placement. Titanium-prepared platelet-rich fibrin (T-PRF) is an autologous platelet concentrate that may enhance soft and hard tissue healing through the sustained release of growth factors. However, clinical evidence regarding its effect on socket healing remains limited.

The aim of this prospective randomized controlled clinical trial is to evaluate the effect of T-PRF on alveolar socket healing following tooth extraction. Participants requiring tooth extraction and subsequent implant placement are randomly assigned to either a T-PRF group or a spontaneous healing (control) group. Cone-beam computed tomography (CBCT) is used to evaluate socket healing volumetrically. The primary outcome is the percentage of socket fill and residual non-ossified socket volume after 3 months. Secondary outcomes include baseline socket volume and postoperative clinical healing.

The findings of this study are expected to provide evidence regarding the effectiveness of T-PRF in enhancing alveolar socket healing and preserving ridge dimensions before implant placement.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

Tooth extraction is commonly followed by physiological alveolar bone resorption, which may compromise subsequent implant placement. Alveolar ridge preservation techniques have been developed to minimize post-extraction dimensional changes. Titanium-prepared platelet-rich fibrin (T-PRF) is an autologous platelet concentrate prepared in titanium tubes without anticoagulants and has been proposed to enhance wound healing and bone regeneration through the sustained release of growth factors.

This prospective randomized controlled clinical trial was conducted at the Department of Periodontology, Eskişehir Osmangazi University. Patients requiring tooth extraction followed by implant placement were screened according to predefined inclusion and exclusion criteria and provided written informed consent before participation.

Participants were randomly allocated to either the T-PRF group or the spontaneous healing (control) group. In the intervention group, T-PRF was prepared from autologous venous blood using titanium tubes and placed into the extraction socket immediately after atraumatic tooth extraction. In the control group, extraction sockets were allowed to heal spontaneously without the use of any socket preservation material. All surgical procedures were performed by the same experienced operator, and postoperative care was standardized for all participants.

Cone-beam computed tomography (CBCT) scans were obtained approximately 10 days after extraction (baseline) and again at 3 months before implant placement. Volumetric measurements were performed using dedicated imaging software by a blinded examiner. The primary outcome was the percentage of socket fill and residual non-ossified socket volume after 3 months. Secondary outcomes included baseline socket volume and clinical healing during the postoperative period.

The results of this study will contribute to the clinical evidence regarding the effectiveness of T-PRF as a minimally invasive autologous biomaterial for enhancing extraction socket healing prior to implant placement.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

30

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Türkei (türkiye)
      • Eskişehir, Türkei (türkiye), 26140
        • Department of Periodontology, Faculty of Dentistry, Eskişehir Osmangazi University

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

Inclusion Criteria:

  • Adults aged 18 to 65 years.
  • Systemically healthy individuals.
  • Indication for tooth extraction followed by implant placement.
  • Adequate bone volume for future implant placement without the need for advanced augmentation procedures.
  • Good oral hygiene (Plaque Index ≤1.5)
  • Ability and willingness to provide written informed consent.

Exclusion Criteria:

  • Current smokers.
  • Pregnant or breastfeeding women.
  • Uncontrolled systemic disease or diabetes mellitus.
  • Use of medications known to affect bone metabolism.
  • History of head and neck radiotherapy or chemotherapy.
  • Acute infection, periapical lesions, alveolar bone pathology, or socket defects at the extraction site.
  • Severe periodontal destruction requiring extensive augmentation procedures.
  • Inability or unwillingness to attend scheduled follow-up visits.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: T-PRF Group
Participants underwent atraumatic tooth extraction followed by placement of autologous titanium-prepared platelet-rich fibrin (T-PRF) into the extraction socket. Standard postoperative care was provided, and healing was evaluated over a 3-month follow-up period.
Biologisch: Titanium-Prepared Platelet-Rich Fibrin (T-PRF)
Autologous titanium-prepared platelet-rich fibrin (T-PRF) was prepared from the participant's venous blood collected into sterile titanium tubes without anticoagulant and centrifuged immediately after blood collection. The resulting fibrin clot was separated from the red blood cell layer, compressed into a membrane, and placed into the extraction socket immediately after atraumatic tooth extraction. The socket was then stabilized with sutures according to the study protocol.
Andere Namen:
  • T-PRF
Kein Eingriff: Control Group
Participants underwent atraumatic tooth extraction followed by placement of autologous titanium-prepared platelet-rich fibrin (T-PRF) into the extraction socket. Standard postoperative care was provided, and healing was evaluated during a 3-month follow-up period.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Percentage of Socket Fill
Zeitfenster: 3 months after tooth extraction
Percentage of socket fill calculated using CBCT-based volumetric analysis by comparing the baseline socket volume with the residual non-ossified socket volume after healing.
3 months after tooth extraction
Percentage of Socket Fill
Zeitfenster: 3 months after tooth extraction
Percentage of socket fill calculated from CBCT-based volumetric measurements by comparing baseline socket volume with the residual non-ossified socket volume after 3 months.
3 months after tooth extraction

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Eskisehir Osmangazi University

Ermittler

  • Studienleiter: hakan özdemir, proffesor, Eskişehir Osmangazi University, Faculty of Dentistry, Department of Periodontology

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

1. März 2023

Primärer Abschluss (Tatsächlich)

29. Dezember 2023

Studienabschluss (Tatsächlich)

29. Dezember 2023

Studienanmeldedaten

Zuerst eingereicht

14. Juli 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

14. Juli 2026

Zuerst gepostet (Tatsächlich)

17. Juli 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

17. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

14. Juli 2026

Zuletzt verifiziert

1. Juli 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Andere Studien-ID-Nummern

  • ESOGU-TPRF-2023-01

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

De-identified individual participant data underlying the results reported in the published article, including demographic characteristics, clinical variables, and CBCT-based volumetric measurements, will be made available.

IPD-Sharing-Zeitrahmen

Beginning 6 months after publication and ending 5 years after publication.

IPD-Sharing-Zugriffskriterien

De-identified individual participant data and the study protocol and statistical analysis plan will be available to qualified researchers who submit a methodologically sound research proposal. Requests should be directed to the corresponding author. Access will be granted after scientific review and approval of the proposal and execution of an appropriate data sharing agreement, where applicable.

Art der unterstützenden IPD-Freigabeinformationen

  • STUDIENPROTOKOLL

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

Abonnieren