- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07712497
Titanium-Prepared Platelet-Rich Fibrin for Extraction Socket Healing (TPRF-SOCKET)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Eskişehir, Turkey (Türkiye), 26140
- Department of Periodontology, Faculty of Dentistry, Eskişehir Osmangazi University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
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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.
Other Names:
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No 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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Percentage of Socket Fill
Time Frame: 3 months after tooth extraction
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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.
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3 months after tooth extraction
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Percentage of Socket Fill
Time Frame: 3 months after tooth extraction
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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
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: hakan özdemir, proffesor, Eskişehir Osmangazi University, Faculty of Dentistry, Department of Periodontology
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- ESOGU-TPRF-2023-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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