Department of Oral & Maxillofacial Surgery, Al Salam University
Tanta, Gharbia Governorate, Egypt
Location status: Recruiting
NCT Number: NCT07508033
This study evaluates two different treatments used to help the jawbone heal after a tooth is removed. When a tooth is extracted, the surrounding bone often shrinks, which can make it difficult to place dental implants later. Currently, doctors often use Platelet-Rich Fibrin (PRF), which is made from the patient's own blood, to help the area heal.
This research compares PRF to a newer treatment using "exosomes" derived from stem cells. Exosomes are tiny particles that carry signals to tell the body to repair tissue and grow new bone. The goal of this study is to see if these exosomes work better than PRF at keeping the bone strong and thick after an extraction. Researchers will use specialized X-rays (CBCT) to measure the bone three months after the procedure to see which treatment provided better results.
Interested in participating?
Request Info20 year–45 year
All sexes
Interventional
Phase 1 / Phase 2
Tanta, Gharbia Governorate, Egypt
Location status: Recruiting
This is a randomized, single-blind, controlled clinical trial designed to compare the regenerative potential of Mesenchymal Stem Cell (MSC)-derived exosomes versus Autologous Platelet-Rich Fibrin (PRF) in alveolar ridge preservation.
A total of 40 patients requiring a single non-infected tooth extraction in the aesthetic zone or premolar area are enrolled and randomized into two equal groups (n=20).
Group A (Intervention): Following atraumatic extraction, MSC-derived exosomes are applied to the extraction socket.
Group B (Control): Following atraumatic extraction, autologous PRF (prepared via centrifugation) is placed in the socket.
The primary outcome measure is the change in alveolar bone density (measured in Hounsfield Units) and ridge dimensions (width and height) using Cone Beam Computed Tomography (CBCT) at baseline and 3 months post-operatively. Secondary outcomes include the assessment of soft tissue healing using the Landry Index, and patient-reported outcomes including postoperative pain (Visual Analog Scale) and swelling. The study aims to determine if the cell-free approach of exosome therapy provides a more standardized and effective alternative to traditional PRF for ridge preservation.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A cell-free regenerative therapy consisting of purified exosomes derived from mesenchymal stem cells, applied to promote bone healing and reduce ridge resorption.
A second-generation platelet concentrate prepared by centrifuging the patient's own blood at the time of surgery to create a fibrin clot rich in growth factors.
Time frame: Baseline (Day of surgery) and 3 months post-operatively.
Bone density will be measured using Cone Beam Computed Tomography (CBCT). The mean Hounsfield Units (HU) will be calculated in the center of the extraction socket to evaluate the quality of new bone formation.
Time frame: Baseline (Day of surgery) and 3 months post-operatively.
The horizontal width and vertical height of the alveolar ridge will be measured in millimeters (mm) using standardized cross-sectional CBCT images to assess the amount of bone resorption or preservation.
Time frame: 7 days and 14 days post-operatively.
Clinical assessment of the surgical site using the Landry, Turnbull, and Heasman Index. The scale ranges from 1 (very poor) to 5 (excellent) based on tissue color, response to palpation, and presence of granulation tissue.
Time frame: Daily for the first 7 days post-operatively.
Pain levels will be self-reported by patients using a Visual Analog Scale (VAS) ranging from 0 (no pain) to 10 (worst imaginable pain).
Contact information is provided by the study sponsor or research team.
Al Salam University
Other
Evaluation of Mesenchymal Stem Cell-Derived Exosomes Versus Platelet-Rich Fibrin (PRF) in Post-Extraction Socket Healing: A Randomized Controlled Clinical Trial.
Acronym: MSC-EXO vs PRF
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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