- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07530471
Autologous Blood Products in Ridge Preservation
Clinical, Radiological, and Ultrasonographic Evaluation of Autologous Blood Products in Alveolar Ridge Preservation: A Randomized Controlled Clinical Trial
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Çanakkale, Turkey (Türkiye)
- Canakkale Onsekiz Mart University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
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 |
|---|---|
|
No Intervention: control
|
|
|
Active Comparator: test
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Horizontal Bone Width Change (CBCT Analysis)
Time Frame: 6 month
|
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
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
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
- OGU-EC-07-25
- 2024-KAEK-15 (Other Identifier: Turkish Medicines and Medical Devices Agency (TİTCK))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Ridge Preservation
-
Cairo UniversityNot yet recruitingSocket Preservation, Alveolar Ridge Deficiency, Alveolar Ridge Preservation
-
Cairo UniversityNot yet recruitingSocket Preservation | Alveolar Ridge PreservationEgypt
-
Cairo UniversityCompletedSocket Preservation | Wound Healing | Alveolar Ridge PreservationEgypt
-
Center for Advanced Rejuvenation and EstheticsCompleted
-
University of Maryland, BaltimoreCompleted
-
University of Alabama at BirminghamCompleted
-
University of Maryland, BaltimoreNot yet recruiting
-
Yasmine FouadCompletedAlveolar Ridge Preservation
-
Mimetis Biomaterials S.L.Active, not recruitingAlveolar Ridge PreservationChile, Spain
-
University of California, San FranciscoCompletedAlveolar Ridge Preservation
Clinical Trials on Autologous Titanium Platelet-Rich Fibrin with Injectable PRF Application
-
University of FloridaCompletedHead and Neck Disorder | Free FlapUnited States
-
Government Dental College and Research Institute...The Oxford Dental College, Hospital and Research Center, Bangalore, IndiaCompleted
-
Hasanuddin UniversityCompletedPostoperative Wound Healing | Salivary Alpha Amylase | Impacted Mandibular Third Molar | Platelet-Rich Fibrin (PRF)Indonesia
-
University of BelgradeFaculty of Medicine, University of BelgradeCompletedKnee Injuries | Anterior Cruciate Ligament Injury | Sensory Disorders | Bone-Patellar Tendon-Bone Autograft | Platelet-Rich Fibrin (PRF)Serbia
-
Poznan University of Medical SciencesCompletedMedication Related Osteonecrosis of the JawPoland
-
Ondokuz Mayıs UniversityCompletedPeriodontitisTurkey (Türkiye)
-
Universidad Católica de CuencaCompletedAlveolar Bone Resorption | Preserving the Alveolar RidgeEcuador
-
Arab International UniversityDamascus UniversityCompletedTitanium-prepared Platelet-rich Fibrin for Treatment of Gingival Recession Using the VISTA TechniqueGingival Diseases | Gingival RecessionSyria
-
Sana'a UniversityRecruitingJaw Cysts | Odontogenic Cyst | Osseous Defect After Cyst EnucleationYemen
-
British University In EgyptCompletedEndodontic Disease | Regenerative EndodonticsEgypt