Actively Recruiting
Evaluation of Mesenchymal Stem Cell-Derived Exosomes Versus Platelet-Rich Fibrin (PRF) in Post-Extraction Socket Healing: A Randomized Controlled Clinical Trial
Led by Al Salam University · Updated on 2026-04-02
40
Participants Needed
1
Research Sites
2 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying two treatments to help the jawbone heal after a tooth is removed, focusing on people who need a single non-infected tooth extraction in the front or premolar area. The trial compares Platelet-Rich Fibrin (PRF), made from the patient's own blood, with a newer therapy using exosomes derived from mesenchymal stem cells. These exosomes are tiny particles that may signal the body to repair tissue and grow new bone, potentially improving healing after extraction. The study includes 40 patients randomly divided into two groups. One group receives mesenchymal stem cell-derived exosomes applied to the extraction socket after tooth removal, while the other group receives autologous PRF prepared from their blood and placed in the socket. The main focus is on measuring changes in bone density and ridge dimensions using specialized 3D X-rays (CBCT) at the time of surgery and three months later. Additional assessments of soft tissue healing, pain, and swelling are done during the first two weeks after surgery. Participants will undergo evaluations including CBCT scans at baseline and three months post-surgery, with soft tissue healing checked at 7 and 14 days after extraction. Patients also report pain levels daily for the first week. The study monitors how well the bone and soft tissue heal, patient comfort, and overall recovery. Participation lasts at least three months, and follow-up visits ensure detailed tracking of healing progress and treatment effects.
CONDITIONS
Brief Title
Evaluation of Stem Cell Exosomes Versus Platelet-Rich Fibrin in Tooth Extraction Socket Healing
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery
Participants undergo tooth extraction followed by placement of either MSC-derived exosomes or autologous Platelet-Rich Fibrin (PRF) in the extraction socket to promote healing.
1 treatment visit (in-person)
Duration - 14 days
Participants are monitored for soft tissue healing, postoperative pain, and swelling.
Daily visits for the first 7 days and 2 additional visits at 7 and 14 days post-operatively
Duration - 3 months post-operatively
Participants undergo assessment of alveolar bone density and ridge dimensions using Cone Beam Computed Tomography (CBCT) to evaluate healing progress.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
Department of Oral & Maxillofacial Surgery, Al Salam University
Tanta, Gharbia Governorate, Egypt
Actively Recruiting
Research Team
O
Omaima M Sakr, BDS, MSc, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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