Evaluating The Use of CGF Plugs in Fresh Odontectomy Socket. (CGF)

April 15, 2026 updated by: Aziz Taysir Haydar, Cairo University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Cairo, Egypt
        • Cairo University Faculty of Dentistry
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CGF Plug Intervention Group
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).
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bone Density
Time Frame: Baseline assessment is conducted immediately after the tooth extraction and CGF plug placement, with a follow-up assessment performed at 3 months postoperatively.
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
Time Frame: Assessments are conducted at three specific intervals: Day 1, Day 3, and Day 7 following the surgical procedure.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Study Director: Abdelmoez Mohamed El-Sharkawy, Associate Professor, Cairo University
  • Study Chair: Hisham Sayed, Professor, Cairo University
  • Principal Investigator: Aziz Taysir Haydar, Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 28, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 30, 2026

Study Registration Dates

First Submitted

April 15, 2026

First Submitted That Met QC Criteria

April 15, 2026

First Posted (Actual)

April 21, 2026

Study Record Updates

Last Update Posted (Actual)

April 21, 2026

Last Update Submitted That Met QC Criteria

April 15, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • omfs 3-3-18-5

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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