Evaluating The Use of CGF Plugs in Fresh Odontectomy Socket.

Официальное название

Clinical and Radiographic Evaluation of the Use of CGF Plugs Packed in Fresh Odontectomy Socket (Case Series Study)

Обзор

This study evaluates the use of Concentrated Growth Factor (CGF) plugs-a third-generation healing material made from the patient's own blood-to improve recovery after simple tooth extractions. CGF contains a dense matrix of growth factors and regenerative cells designed to enhance wound healing and tissue regeneration. Participants requiring a single, non-surgical tooth extraction will have a CGF plug placed into the empty socket immediately following the procedure. The researchers will then monitor two main factors: * Post-operative Pain: Patients will record their pain levels on a scale of 0 to 10 at 1, 3, and 7 days after the extraction. * Bone Density: Using specialized imaging (CBCT), the researchers will measure how well the bone heals and fills the socket immediately after the procedure and again at 3 months. The goal of this research is to determine if CGF plugs can effectively reduce patient discomfort and help preserve bone density, which is critical for future dental treatments like implants.

Подробное описание

Study Design and Setting This study is a prospective case series conducted in a minor surgery setting. The trial evaluates the clinical and radiographic outcomes of using Concentrated Growth Factor (CGF) plugs in fresh extraction sockets following simple, non-surgical tooth extractions.

Intervention and CGF Preparation

The surgical intervention follows a standardized protocol:

* Preoperative Phase: Patients provide written informed consent. They perform a 0.12% chlorhexidine gluconate mouth rinse and receive baseline imaging via Cone-beam computed tomography (CBCT) for extraction site evaluation. * CGF Preparation: 10 mL of blood is drawn into a sterile tube without anticoagulants. This is centrifuged using a CGF-specific machine. The CGF clot is separated from the red blood cells, placed in a plug mold, and compressed into a stable plug using a PRF tray. * Surgical Procedure: Under local anesthesia, an atraumatic extraction is performed using forceps and elevators to avoid damage to socket walls. The socket is curetted to remove granulation tissue and tooth fragments, then irrigated with sterile saline. The CGF plug is inserted into the socket, which is then sutured using Vicryl.

Outcome Assessment

The study focuses on two main recovery indicators:

* Radiographic Evaluation (Primary): CBCT scans are taken immediately after extraction and at 3 months post-op to assess changes in bone density over time. These measurements are recorded in Hounsfield units. * Clinical Evaluation (Secondary): Postoperative pain is assessed using the Verbal Numeric Rating Scale (VNRS), where 0 represents "No pain" and 10 represents "Worst imaginable pain". Assessments are conducted on Day 1, Day 3, and Day 7.

Data Management and Monitoring All study data is entered electronically. Patients' files are stored in numerical order in a secure and accessible place, with data maintained in storage for one year after the completion of the study. Data entry is transmitted from the assessor to a database officer as blind separate datasheets before being recorded in a participant chart. Access to study data is restricted to the database officer, and a complete backup of the primary database is performed twice a month.

Safety and Ethics Intraoperative and postoperative harms, such as excessive bleeding or infection, are managed through atraumatic techniques, sterile protocols, and prescribed medications including antibiotics and analgesics. Any modifications to the protocol that may impact the conduct of the study or patient safety require a formal amendment agreed upon by the department council.

Вмешательства

• Другое Concentrated Growth Factor (CGF) Plug
  The intervention involves preparing an autologous Concentrated Growth Factor (CGF) plug from the patient's blood using variable-speed centrifugation and placing it into a fresh, curetted extraction socket to evaluate its impact on bone density and postoperative pain.

Первичные конечные точки

• Bone Density [Срок оценки: Baseline assessment is conducted immediately after the tooth extraction and CGF plug placement, with a follow-up assessment performed at 3 months postoperatively.]
• Post Operative Pain [Срок оценки: Assessments are conducted at three specific intervals: Day 1, Day 3, and Day 7 following the surgical procedure.]

Критерии участия

Критерии включения

• Systemically healthy patients (ASA I or II)
• Age between 20 and 50 years
• Require simple, non-surgical extraction of a single tooth
• Presence of periapical radiolucency at the extraction site
• Willingness to comply with follow-up and provide signed informed consent

Критерии исключения

• • Systemic diseases (e.g., uncontrolled diabetes, bone metabolic disorders)

• History of radiotherapy or chemotherapy
• Use of medications affecting bone metabolism (e.g., bisphosphonates, chronic steroids)
• Heavy smokers
• Pregnant or lactating women
• Poor oral hygiene or active acute infection/suppuration at the site

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Египет · 1 центр

• Cairo University Faculty of Dentistry — Cairo

Идентификаторы

NCT: NCT07542795 · omfs 3-3-18-5

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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