Alveolar Bone Loss, Tooth Extraction, Bone Regeneration
Conditions
Keywords
MSC-derived Exosomes, Platelet-Rich Fibrin (PRF), Alveolar Ridge Preservation, Socket Grafting, Cone-Beam Computed Tomography (CBCT), Stem Cell Secretome, Bone Density
Brief summary
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.
Detailed description
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.
Interventions
BIOLOGICALMSC-Derived Exosomes
A cell-free regenerative therapy consisting of purified exosomes derived from mesenchymal stem cells, applied to promote bone healing and reduce ridge resorption.
BIOLOGICALPlatelet-rich fibrin (PRF)
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.
Sponsors
Al Salam University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Patients aged between 20 and 45 years. * Patients requiring a single tooth extraction of a non-infected tooth in the aesthetic zone (incisors, canines) or premolar area. * Presence of adjacent teeth to the extraction site. * Adequate oral hygiene (Plaque Index \< 20%). * Patients willing and able to comply with the follow-up schedule and 3-month CBCT scan. * Signed informed consent provided by the participant.
Exclusion criteria
* Patients with systemic diseases that contraindicate oral surgery or interfere with bone healing (e.g., uncontrolled diabetes, osteoporosis, hyperparathyroidism). * History of head and neck radiation therapy or bisphosphonate medication use. * Active infection or acute abscess at the extraction site. * Heavy smokers (more than 10 cigarettes per day). * Pregnant or lactating women. * Patients with poor oral hygiene or active periodontal disease in the rest of the mouth. * Use of any medications known to affect bone metabolism (e.g., long-term corticosteroids).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Alveolar Bone Density (Hounsfield Units) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Alveolar Ridge Dimensional Changes (Height and Width) | 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. |
| Soft Tissue Healing Score (Landry Index) | 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. |
| Patient-Reported Postoperative Pain (VAS Score) | 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). |
Countries
Egypt
Contacts
CONTACTOmaima M Sakr, BDS, MSc, PhD
PRINCIPAL_INVESTIGATOROmaima M Sakr, BDS, MSc, PhD
Al Salam University, Faculty of Oral & Dental Medicine, Egypt
Outcome results
None listed