NCT07712497

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 29, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 29, 2023

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

July 14, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 17, 2026

Completed
Last Updated

July 17, 2026

Status Verified

July 1, 2026

Enrollment Period

10 months

First QC Date

July 14, 2026

Last Update Submit

July 14, 2026

Conditions

Keywords

Titanium-Prepared Platelet-Rich Fibrin, Alveolar Ridge Preservation, Cone-Beam Computed Tomography,

Outcome Measures

Primary Outcomes (2)

  • Percentage of Socket Fill

    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

    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

Study Arms (2)

T-PRF Group

EXPERIMENTAL

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.

Biological: Titanium-Prepared Platelet-Rich Fibrin (T-PRF)

Control Group

NO INTERVENTION

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.

Interventions

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.

Also known as: T-PRF
T-PRF Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Periodontology, Faculty of Dentistry, Eskişehir Osmangazi University

Eskişehir, 26140, Turkey (Türkiye)

Location

Study Officials

  • hakan özdemir, proffesor

    Eskişehir Osmangazi University, Faculty of Dentistry, Department of Periodontology

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Radiographic volumetric measurements were performed by an outcome assessor who was blinded to the treatment allocation. No other study personnel were masked.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants were randomly assigned to one of two parallel groups. The intervention group received titanium-prepared platelet-rich fibrin (T-PRF) following atraumatic tooth extraction, whereas the control group underwent spontaneous socket healing without any socket preservation material. Clinical and volumetric radiographic outcomes were assessed over a 3-month follow-up period.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

July 14, 2026

First Posted

July 17, 2026

Study Start

March 1, 2023

Primary Completion

December 29, 2023

Study Completion

December 29, 2023

Last Updated

July 17, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL
Time Frame
Beginning 6 months after publication and ending 5 years after publication.
Access Criteria
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.

Locations