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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Биопрепарат 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.
• Биопрепарат 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.

Первичные конечные точки

• Change in Alveolar Bone Density (Hounsfield Units) [Срок оценки: Baseline (Day of surgery) and 3 months post-operatively.]

Вторичные конечные точки (3)

• Alveolar Ridge Dimensional Changes (Height and Width) [Срок оценки: Baseline (Day of surgery) and 3 months post-operatively.]
• Soft Tissue Healing Score (Landry Index) [Срок оценки: 7 days and 14 days post-operatively.]
• Patient-Reported Postoperative Pain (VAS Score) [Срок оценки: Daily for the first 7 days post-operatively.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Египет · 1 центр

• Department of Oral & Maxillofacial Surgery, Al Salam University — Tanta

Идентификаторы

NCT: NCT07508033 · Sue010401263 · SCCREIRB-01130125

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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