Alveolar Bone LossPhase 1/2MSC-EXO vs PRFNCT07508033
Evaluation of Stem Cell Exosomes Versus Platelet-Rich Fibrin in Tooth Extraction Socket Healing
A Phase 1/2 study testing MSC-Derived Exosomes and Platelet-rich fibrin (PRF) in people with Alveolar Bone Loss and Tooth Extraction, run by Al Salam University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Alveolar Bone Loss, Tooth Extraction, Bone Regeneration
- What is being tested?
- MSC-Derived Exosomes and Platelet-rich fibrin (PRF)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jan 2026to 1 Aug 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Department of Oral & Maxillofacial Surgery, Al Salam University
Tanta, Gharbia Governorate
Omaima M Sakr, BDS, MSc, PhD, +201001051538
About this study
Official title: Evaluation of Mesenchymal Stem Cell-Derived Exosomes Versus Platelet-Rich Fibrin (PRF) in Post-Extraction Socket Healing: A Randomized Controlled Clinical Trial.
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.
Read the 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.
- Conditions
- Alveolar Bone Loss, Tooth Extraction, Bone Regeneration
- Being tested
- MSC-Derived Exosomes, Platelet-rich fibrin (PRF)
- Keywords
- MSC-derived Exosomes, Platelet-Rich Fibrin (PRF), Alveolar Ridge Preservation, Socket Grafting, Cone-Beam Computed Tomography (CBCT), Stem Cell Secretome, Bone Density
- Medical subject headings
- Alveolar Bone Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MSC-Derived ExosomesBiological
A cell-free regenerative therapy consisting of purified exosomes derived from mesenchymal stem cells, applied to promote bone healing and reduce ridge resorption.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: MSC-Derived Exosomes |
| PRF Group | Active comparator | Patients in this group will receive autologous Platelet-Rich Fibrin (PRF) placed into the extraction socket immediately following tooth removal. Receives: Biological: Platelet-rich fibrin (PRF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (Day of surgery) and 3 months post-operatively.
Secondary outcomes (3)
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.
Measured: Baseline (Day of surgery) and 3 months post-operatively.
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.
Measured: 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).
Measured: Daily for the first 7 days post-operatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2026
- Study start15 Jan 2026
- Primary completion15 Jul 2026 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar Bone LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al Salam University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Omaima M Sakr, BDS, MSc, PhD, Principal investigator, Al Salam University, Faculty of Oral & Dental Medicine, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07508033
- Sponsor's protocol ID
- Sue010401263
- Other IDs
- SCCREIRB-01130125
- Acronym
- MSC-EXO vs PRF
- Status last verified
- Mar 2026
- First submitted
- 27 Mar 2026
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Mesenchymal Stem Cell-Derived Exosomes Versus Platelet-Rich Fibrin (PRF) in Post-Extraction Socket Healing: A Randomized Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT07508033
- Acronym / sponsor ID
- MSC-EXO vs PRF / Sue010401263
- Conditions
- Alveolar Bone Loss, Tooth Extraction, Bone Regeneration
- Keywords
- MSC-derived Exosomes, Platelet-Rich Fibrin (PRF), Alveolar Ridge Preservation, Socket Grafting, Cone-Beam Computed Tomography (CBCT), Stem Cell Secretome, Bone Density
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Al Salam UniversityUniversity, hospital or other
- Study start
- 15 Jan 2026 (actual)
- Primary completion
- 15 Jul 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 2 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group (MSC-Exosomes) | Experimental | Biological: MSC-Derived ExosomesPatients in this group will receive Mesenchymal Stem Cell (MSC)-derived exosomes placed into the extraction socket immediately following tooth removal. |
| PRF Group | Active comparator | Biological: Platelet-rich fibrin (PRF)Patients in this group will receive autologous Platelet-Rich Fibrin (PRF) placed into the extraction socket immediately following tooth removal. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MSC-Derived ExosomesA cell-free regenerative therapy consisting of purified exosomes derived from mesenchymal stem cells, applied to promote bone healing and reduce ridge resorption. | Biological | Experimental Group (MSC-Exosomes) |
| Platelet-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. | Biological | PRF Group |
Primary outcome
Change in Alveolar Bone Density (Hounsfield Units)
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.
3 secondary outcomes
Alveolar Ridge Dimensional Changes (Height and Width)
Time frame: Baseline (Day of surgery) and 3 months post-operatively.
Soft Tissue Healing Score (Landry Index)
Time frame: 7 days and 14 days post-operatively.
Patient-Reported Postoperative Pain (VAS Score)
Time frame: Daily for the first 7 days post-operatively.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Omaima M Sakr, BDS, MSc, PhD principal investigator
Al Salam University, Faculty of Oral & Dental Medicine, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing MSC-Derived Exosomes and Platelet-rich fibrin (PRF) in people with Alveolar Bone Loss and Tooth Extraction, run by Al Salam University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Omaima M Sakr, BDS, MSc, PhD (+201001051538, drsakr2009@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Alveolar Bone Density (Hounsfield Units) (time frame: Baseline (Day of surgery) and 3 months post-operatively.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2026.