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NCT Number: NCT07508033

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

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.

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Key information

Age range

20 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Department of Oral & Maxillofacial Surgery, Al Salam University

Tanta, Gharbia Governorate, Egypt

Location status: Recruiting

Location contact

Omaima M Sakr, BDS, MSc, PhD

CONTACT

+201001051538

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Alveolar Ridge Dimensional Changes (Height and Width)

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

    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.

  2. Soft Tissue Healing Score (Landry Index)

    Time frame: 7 days and 14 days post-operatively.

    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.

  3. Patient-Reported Postoperative Pain (VAS Score)

    Time frame: Daily for the first 7 days post-operatively.

    Pain levels will be self-reported by patients using a Visual Analog Scale (VAS) ranging from 0 (no pain) to 10 (worst imaginable pain).

Study contacts

Contact information is provided by the study sponsor or research team.

Omaima M Sakr, BDS, MSc, PhD

CONTACT

[email protected]

+201001051538

Sponsors and collaborators

Lead sponsor

Al Salam University

Other

Registry information

Official study title

Evaluation of Mesenchymal Stem Cell-Derived Exosomes Versus Platelet-Rich Fibrin (PRF) in Post-Extraction Socket Healing: A Randomized Controlled Clinical Trial.

Acronym: MSC-EXO vs PRF

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 2, 2026
Registry last updated
Apr 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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