Evaluation of Stem Cell Exosomes Versus Platelet-Rich Fibrin in Tooth Extraction Socket Healing (MSC-EXO vs PRF)

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.

Study Overview

• Status: Recruiting
• Conditions: Alveolar Bone Loss; Bone Regeneration; Tooth Extraction
• Intervention / Treatment: Biological: MSC-Derived Exosomes; Biological: Platelet-rich fibrin (PRF)

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 Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Omaima M Sakr, BDS, MSc, PhD; Phone Number: +201001051538; Email: drsakr2009@hotmail.com

Study Locations

• Egypt
  • Gharbia Governorate
    • Tanta, Gharbia Governorate, Egypt
      • Recruiting
      • Department of Oral & Maxillofacial Surgery, Al Salam University
      • Contact: Omaima M Sakr, BDS, MSc, PhD; Phone Number: +201001051538

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Group (MSC-Exosomes); Patients in this group will receive Mesenchymal Stem Cell (MSC)-derived exosomes placed into the extraction socket immediately following tooth removal.	Biological: MSC-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.
Active Comparator: PRF Group; Patients in this group will receive autologous Platelet-Rich Fibrin (PRF) placed into the extraction socket immediately following tooth removal.	Biological: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Secondary Outcome Measures

Outcome Measure	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.
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.

Collaborators and Investigators

• Sponsor: Al Salam University
• Investigators: Principal Investigator: Omaima M Sakr, BDS, MSc, PhD, Al Salam University, Faculty of Oral & Dental Medicine, Egypt

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2026
• Primary Completion (Estimated): July 15, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: March 27, 2026
• First Submitted That Met QC Criteria: March 27, 2026
• First Posted (Actual): April 2, 2026

Study Record Updates

• Last Update Posted (Actual): April 2, 2026
• Last Update Submitted That Met QC Criteria: March 27, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Bone Density; Alveolar Ridge Preservation; Platelet-Rich Fibrin (PRF); MSC-derived Exosomes; Socket Grafting; Cone-Beam Computed Tomography (CBCT); Stem Cell Secretome
• Additional Relevant MeSH Terms: Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Alveolar Bone Loss
• Other Study ID Numbers: Sue010401263; SCCREIRB-01130125 (Other Identifier: Al Salam University)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No