Stem cell exosomes versus platelet-rich fibrin for healing after a tooth extraction
Evaluation of Mesenchymal Stem Cell-Derived Exosomes Versus Platelet-Rich Fibrin (PRF) in Post-Extraction Socket Healing: A Randomized Controlled Clinical Trial.
This trial tests whether stem cell-derived exosomes or platelet-rich fibrin (PRF) better help the jawbone stay strong after removing a single non-infected front or premolar tooth in adults aged 20–45.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 20 Years to 45 Years |
| Sex | All |
| Sponsor | Al Salam University Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Tanta, Gharbia Governorate) |
| Trial ID | NCT07508033 on ClinicalTrials.gov |
What this trial studies
This randomized, single-blind trial enrolls 40 adults who need a single non-infected extraction in the aesthetic or premolar zone and assigns them to receive either MSC-derived exosomes or autologous PRF placed in the socket after atraumatic extraction. Outcomes are measured with baseline and 3-month cone beam CT (CBCT) scans to compare changes in alveolar bone density and ridge dimensions. Secondary measures include soft tissue healing by the Landry Index and patient-reported pain and swelling. The trial tests whether a cell-free exosome approach provides more standardized or improved ridge preservation compared with the current PRF technique.
Who should consider this trial
Good fit: Adults 20–45 needing a single non-infected incisor/canine or premolar extraction with adjacent teeth, good oral hygiene, and willingness to return for a 3‑month CBCT are the ideal candidates.
Not a fit: Patients with active infection at the extraction site, systemic conditions or medications that impair bone healing, heavy smokers, pregnant or lactating women, or those unable to attend follow-up are unlikely to receive benefit from this protocol.
Why it matters
Potential benefit: If successful, exosome treatment could provide more consistent and potentially stronger bone preservation after extraction, making later implant placement easier.
How similar studies have performed: Preclinical studies and limited early-phase human work suggest MSC-derived exosomes can promote bone and soft-tissue repair, but randomized head-to-head comparisons with PRF for alveolar ridge preservation are still limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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).
Where this trial is running
Tanta, Gharbia Governorate
- Department of Oral & Maxillofacial Surgery, Al Salam University — Tanta, Gharbia Governorate, Egypt (Recruiting)
Study contacts
- Principal investigator: Omaima M Sakr, BDS, MSc, PhD — Al Salam University, Faculty of Oral & Dental Medicine, Egypt
- Study coordinator: Omaima M Sakr, BDS, MSc, PhD
- Email: drsakr2009@hotmail.com
- Phone: +201001051538
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.