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

14 juillet 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

30

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Turquie (Türkiye)
      • Eskişehir, Turquie (Türkiye), 26140
        • Department of Periodontology, Faculty of Dentistry, Eskişehir Osmangazi University

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Biologique: 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.
Autres noms:
  • T-PRF
Aucune intervention: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Percentage of Socket Fill
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Eskisehir Osmangazi University

Les enquêteurs

  • Directeur d'études: hakan özdemir, proffesor, Eskişehir Osmangazi University, Faculty of Dentistry, Department of Periodontology

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 mars 2023

Achèvement primaire (Réel)

29 décembre 2023

Achèvement de l'étude (Réel)

29 décembre 2023

Dates d'inscription aux études

Première soumission

14 juillet 2026

Première soumission répondant aux critères de contrôle qualité

14 juillet 2026

Première publication (Réel)

17 juillet 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

17 juillet 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

14 juillet 2026

Dernière vérification

1 juillet 2026

Plus d'information

Termes liés à cette étude

Mots clés

Autres numéros d'identification d'étude

  • ESOGU-TPRF-2023-01

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

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.

Délai de partage IPD

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

Critères d'accès au partage IPD

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.

Type d'informations de prise en charge du partage d'IPD

  • PROTOCOLE D'ÉTUDE

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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