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| ID | Type | Description | Link |
|---|---|---|---|
| SCCREIRB-01130125 | Other Identifier | Al Salam University |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group (MSC-Exosomes) | Experimental | Patients in this group will receive Mesenchymal Stem Cell (MSC)-derived exosomes placed into the extraction socket immediately following tooth removal. |
|
| PRF Group | Active Comparator | Patients in this group will receive autologous Platelet-Rich Fibrin (PRF) placed into the extraction socket immediately following tooth removal. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MSC-Derived Exosomes | Biological | A cell-free regenerative therapy consisting of purified exosomes derived from mesenchymal stem cells, applied to promote bone healing and reduce ridge resorption. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Alveolar Bone Density (Hounsfield Units) | 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. | Baseline (Day of surgery) and 3 months post-operatively. |
| Measure | Description | Time Frame |
|---|---|---|
| Alveolar Ridge Dimensional Changes (Height and Width) | 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. | Baseline (Day of surgery) and 3 months post-operatively. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Omaima M Sakr, BDS, MSc, PhD | Contact | +201001051538 | drsakr2009@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Omaima M Sakr, BDS, MSc, PhD | Al Salam University, Faculty of Oral & Dental Medicine, Egypt | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Oral & Maxillofacial Surgery, Al Salam University | Recruiting | Tanta | Gharbia Governorate | Egypt |
Individual participant data (IPD) will not be shared to protect the intellectual property of the research prior to official publication. Furthermore, the informed consent provided by the participants did not include a provision for the public sharing of raw individual data, ensuring the maintenance of patient confidentiality and privacy according to institutional ethics committee guidelines.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 4, 2026 | Mar 27, 2026 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 4, 2026 | Mar 27, 2026 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D016301 | Alveolar Bone Loss |
| ID | Term |
|---|---|
| D001862 | Bone Resorption |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D055093 | Periodontal Atrophy |
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| Platelet-rich fibrin (PRF) | Biological | 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. |
|
| Soft Tissue Healing Score (Landry Index) |
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. |
| 7 days and 14 days post-operatively. |
| Patient-Reported Postoperative Pain (VAS Score) | Pain levels will be self-reported by patients using a Visual Analog Scale (VAS) ranging from 0 (no pain) to 10 (worst imaginable pain). | Daily for the first 7 days post-operatively. |
| D010510 |
| Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |