Evaluation of Stem Cell Exosomes Versus Platelet-Rich Fibrin in Tooth Extraction Socket Healing

NCT07508033 | Recruiting Phase 1

• 2 other identifiers: Sue010401263SCCREIRB-01130125
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Alveolar Ridge Dimensional Changes (Height and Width)

  Baseline (Day of surgery) and 3 months post-operatively.

• Soft Tissue Healing Score (Landry Index)

  7 days and 14 days post-operatively.

• Patient-Reported Postoperative Pain (VAS Score)

  Daily for the first 7 days post-operatively.

Study Arms (2)

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.

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.

Biological: Platelet-rich fibrin (PRF)

Interventions

MSC-Derived Exosomes BIOLOGICAL

A cell-free regenerative therapy consisting of purified exosomes derived from mesenchymal stem cells, applied to promote bone healing and reduce ridge resorption.

Experimental Group (MSC-Exosomes)

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.

PRF Group

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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 may not qualify if:

• 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).

Sponsors & Collaborators

• Al Salam University: lead

Study Sites (1)

Department of Oral & Maxillofacial Surgery, Al Salam University

Tanta, Gharbia Governorate, Egypt

RECRUITING

MeSH Terms

Conditions

Alveolar Bone Loss

Condition Hierarchy (Ancestors)

Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Omaima M Sakr, BDS, MSc, PhD

  Al Salam University, Faculty of Oral & Dental Medicine, Egypt

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Omaima M Sakr, BDS, MSc, PhD

CONTACT

+201001051538; drsakr2009@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2026
• First Posted: April 2, 2026
• Study Start: January 15, 2026
• Primary Completion (Estimated): July 15, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: April 2, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)