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Not yet recruiting Not applicable NCT07542795

Evaluating The Use of CGF Plugs in Fresh Odontectomy Socket.

No applicable phase (e.g. observational)
Conditions: Odontectomy (Tooth Extraction) Socket Preservation and Healing Following Simple, Non-surgical Extraction Alveolar Bone Density and Postoperative Pain Management Periapical Radiolucency

Sponsor: Cairo University

trial.available_in: БГ
Overview
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.
Description
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.
Who can participate
Inclusion Criteria: * 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 Exclusion Criteria: * • 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
Interventions
Concentrated Growth Factor (CGF) Plug
OTHER
Locations 1
Egypt (1)
Cairo University Faculty of Dentistry
Cairo
Technical details
Status
Not yet recruiting
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
20 Years
Maximum age
50 Years
Healthy volunteers
No
Start date
28.09.2026
Completion date
30.12.2026
Registry ID
NCT07542795
Source
clinicaltrials.gov
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