NCT07530471

Brief Summary

This randomized controlled clinical trial aims to evaluate the clinical, radiographic, and ultrasonographic outcomes of alveolar ridge preservation using autologous blood products following tooth extraction. After tooth extraction, dimensional changes occur in both hard and soft tissues, which may negatively affect future implant or prosthetic treatments. This study investigates whether the application of Titanium Platelet-Rich Fibrin (T-PRF), combined with injectable Platelet-Rich Fibrin (i-PRF), can improve healing and reduce tissue changes. In this study, tooth extraction will be performed under local anesthesia using minimally invasive techniques. Autologous blood will be collected from the patient and processed by centrifugation to obtain T-PRF and i-PRF. The prepared materials will be applied to the extraction socket and stabilized with sutures. Healing will be monitored through clinical examinations, radiographic imaging, and ultrasonographic evaluations over a 6-month follow-up period. Possible risks include pain, bleeding, infection, and temporary discomfort, all of which are manageable with standard clinical care. The study is expected to contribute to the development of biologically based, minimally invasive treatment approaches that enhance tissue healing and support future dental treatments.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
8mo left

Started Apr 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress13%
Apr 2026Jan 2027

First Submitted

Initial submission to the registry

April 1, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 15, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

April 15, 2026

Status Verified

April 1, 2026

Enrollment Period

7 months

First QC Date

April 1, 2026

Last Update Submit

April 8, 2026

Conditions

Keywords

Ridge PreservationT-PRFi-PRFT-PRF Plus

Outcome Measures

Primary Outcomes (1)

  • Horizontal Bone Width Change (CBCT Analysis)

    Evaluation of horizontal bone width in millimeters at standardized levels (1 mm, 3 mm, and 5 mm from the alveolar crest) using CBCT at baseline (immediately after extraction) and 6 months

    6 month

Study Arms (2)

control

NO INTERVENTION

test

ACTIVE COMPARATOR
Procedure: Autologous Titanium Platelet-Rich Fibrin with Injectable PRF Application

Interventions

Following atraumatic tooth extraction under local anesthesia, autologous blood will be collected from the patient. Titanium platelet-rich fibrin (T-PRF) will be prepared by centrifugation of blood in titanium tubes, and injectable platelet-rich fibrin (i-PRF) will be obtained using a low-speed centrifugation protocol. The prepared i-PRF will be injected into the T-PRF membrane to create a combined autologous fibrin construct. This material will then be placed into the extraction socket to support clot stability and tissue regeneration, and the site will be sutured for stabilization. This approach combines the dense fibrin structure of T-PRF with the biological activity of i-PRF, aiming to enhance angiogenesis, soft and hard tissue healing, and preservation of alveolar ridge dimensions.

test

Eligibility Criteria

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

You may qualify if:

  • Systemically healthy individuals with no medical conditions that could interfere with periodontal treatment, tooth extraction, or wound healing
  • Absence of systemic diseases affecting blood coagulation and no use of anticoagulant medications
  • No history of blood-borne infectious diseases
  • Non-smokers
  • Age ≥18 years
  • Patients requiring extraction of a single-rooted tooth in the maxilla or mandible
  • Availability of a pre-existing CBCT scan of the planned extraction site
  • Extraction site suitable for implant placement

You may not qualify if:

  • Presence of systemic diseases that may affect periodontal treatment, tooth extraction, wound healing, or increase the risk of complications
  • Presence of bleeding or coagulation disorders, or use of anticoagulant therapy
  • Presence of blood-borne infectious diseases
  • Smoking habit
  • Age \<18 years
  • Psychological or mental conditions that may affect compliance with treatment or study participation
  • Extraction sites not suitable for implant placement
  • History of previous surgical intervention or compromised healing in the extraction site
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Çanakkale Onsekiz Mart University

Çanakkale, Turkey (Türkiye)

Location

Related Publications (1)

  • Araujo MG, Lindhe J. Dimensional ridge alterations following tooth extraction. An experimental study in the dog. J Clin Periodontol. 2005 Feb;32(2):212-8. doi: 10.1111/j.1600-051X.2005.00642.x.

    PMID: 15691354BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

April 1, 2026

First Posted

April 15, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

January 1, 2027

Last Updated

April 15, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations