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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:
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.
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:
Outcome Assessment
The study focuses on two main recovery indicators:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CGF Plug Intervention Group | Experimental | This arm involves patients requiring simple, non-surgical extraction of a single tooth. Following an atraumatic extraction and socket curettage, a Concentrated Growth Factor (CGF) plug is packed into the fresh odontectomy site. The CGF plug is prepared by centrifuging 10 mL of the patient's own blood using a specialized variable-speed protocol to create a dense fibrin matrix. After the plug is inserted, the wound is secured with Vicryl sutures. Participants in this arm are evaluated for changes in bone density via CBCT imaging and for postoperative pain using the Verbal Numeric Rating Scale (VNRS). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Concentrated Growth Factor (CGF) Plug | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Bone Density | Evaluation of the extraction socket using Cone-beam computed tomography (CBCT) to assess changes in bone healing and preservation. Measurements are specifically analyzed and recorded using the Hounsfield unit scale to quantify mineral density within the site. | 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 | Clinical evaluation of pain using the Verbal Numeric Rating Scale (VNRS), where participants rate their pain on a scale from 0 to 10 (0 = No pain, 10 = Worst imaginable pain). | Assessments are conducted at three specific intervals: Day 1, Day 3, and Day 7 following the surgical procedure. |
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Inclusion Criteria:
Exclusion Criteria:
• Systemic diseases (e.g., uncontrolled diabetes, bone metabolic disorders)
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aziz Taysir Haydar | Contact | +201080823761 | +966550484556 | Zizoaziz66@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Hisham Sayed, Professor | Cairo University | Study Chair |
| Abdelmoez Mohamed El-Sharkawy, Associate Professor | Cairo University | Study Director |
| Aziz Taysir Haydar |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cairo University Faculty of Dentistry | Cairo | Egypt |
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|
| Cairo University |
| Principal Investigator |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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