Evaluating The Use of CGF Made Plugs in Mandibular Extraction Sites of Lower Impacted 3rd Molars. (CGF)

April 2, 2026 updated by: MESHARI MOHAMMED ALHARBI, Cairo University

Clinical and Radiographic Evaluation of The Use of CGF Plugs Packed in Fresh Odontectomy Site of Impacted Lower 3rd Molars (Case Series Study)

The goal of this clinical trial is to learn if Concentrated Growth Factor (CGF) plugs help improve bone healing and reduce pain after the surgical removal of impacted lower third molars.

The study aims to answer the following:

Does packing CGF plugs into the extraction site improve bone density? Does the use of CGF plugs reduce postoperative pain for the patient?

Researchers will evaluate the healing outcomes of patients receiving this treatment in a prospective case series study. Because this is a case series, all participants will receive the CGF plug intervention rather than being compared to a placebo group.

Participants in this study will:

Undergo a blood draw to create the autologous CGF plug from their own growth factors.

Undergo the surgical extraction of an impacted lower third molar under local anesthesia.

Have a CGF plug placed in the extraction socket immediately following the tooth removal.

Report their pain levels using a numeric scale on Day 1, Day 3, and Day 7 after surgery.

Return for a follow-up CBCT scan three months after the procedure to evaluate bone density changes.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The surgical removal of impacted lower third molars, commonly known as wisdom teeth, is one of the most frequent procedures in oral surgery. While routine, this procedure often leads to significant postoperative challenges, including pain and substantial bone loss in the extraction area. This bone loss can compromise the health of the adjacent teeth and the surrounding periodontal tissue.

To improve healing outcomes, this study investigates the use of Concentrated Growth Factor (CGF). CGF is a third-generation autologous platelet concentrate-meaning it is derived from the patient's own blood. Unlike earlier versions like PRP or PRF, CGF is created using a specialized variable-speed centrifugation process that results in a denser fibrin matrix. This matrix is rich in growth factors and regenerative cells, which may offer superior mechanical properties and a more sustained release of healing factors to promote bone regeneration and reduce pain.

The researchers aims to evaluate the clinical and radiographic effectiveness of using CGF in a "plug" form. The CGF plug is valued for its stability and ease of handling within the surgical site. The study specifically looks at:

Bone Density Improvement: Measuring how well the extraction site fills with new bone over three months.

Pain Management: Assessing whether the biological properties of CGF can lower the intensity of pain experienced by patients in the week following surgery.

On the day of surgery, the Principal Investigator will collect a small sample (10mL) of the participant's blood into a sterile tube without anticoagulants. This sample is then processed in a centrifugation machine under dedicated CGF extraction settings. Once the blood has been separated, the resulting fibrin clot is removed and placed into a specialized mold to compress it into a stable "plug" shape, ready for immediate placement into the tooth socket.

All surgeries will be performed under local anesthesia in a sterile minor surgery setting. After ensuring the area is fully anesthetized, the Principal Investigator will Carefully remove the impacted wisdom tooth using standard surgical techniques.

Clean the extraction socket to remove any debris or fragments. Pack the prepared CGF plug directly into the fresh extraction site. Suture the wound closed using absorbable sutures.

Following the procedure, the Principal Investigator will monitor the participants' recovery through two primary parameters:

Pain Assessment: Participants will record their pain levels using the Verbal Numeric Rating Scale (VNRS), where 0 represents no pain and 10 represents the worst imaginable pain. These assessments occur on Day 1, Day 3, and Day 7 post-surgery.

Radiographic Evaluation: To measure bone healing, Cone-Beam Computed Tomography (CBCT) scans will be taken immediately after surgery and again at 3 months. These scans allow for the calculation of changes in bone density using Hounsfield units.

The study is conducted with strict adherence to patient safety and ethical standards. Any potential risks, such as postoperative infection or bleeding, will be managed through prophylactic antibiotics, sterile protocols, and clear emergency contact instructions. Participation is voluntary, and all participants must provide written informed consent before the study begins.

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Not Applicable

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
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Patients aged 18 years or older
  • Both male and female patients
  • Patients requiring odontectomy of an impacted lower third molar

Exclusion Criteria:

  • Patients who are pre-surgically symptomatic
  • Use of medications that affect bleeding time or bone remodeling
  • Patients with a history of radiotherapy or chemotherapy
  • Patients who are pregnant or lactating
  • Patients using oral contraceptives
  • Patients with acute or chronic infections
  • Patients with any kind of pathology confirmed radiographically

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 is a single-arm, prospective study where all participants receive the same intervention. Participants requiring the surgical removal of an impacted lower third molar will undergo a standard odontectomy procedure under local anesthesia. Immediately following the tooth extraction, a prepared autologous Concentrated Growth Factor (CGF) plug derived from the patient's own blood is packed into the fresh extraction socket. The site is then sutured. The arm focuses on evaluating the subsequent healing process, specifically monitoring postoperative pain levels during the first week and measuring changes in alveolar bone density via CBCT scans at a three month follow up.
Other: Concentrated Growth Factor (CGF) Plug
This is a third-generation autologous blood concentrate prepared using a dedicated centrifugation system. The process creates a fibrin-rich organic matrix from the patient's own blood, which is then molded into a plug form and packed into the fresh extraction socket to enhance healing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bone Density
Time Frame: A Cone-beam computed tomography (CBCT) scan is taken immediately after the surgical procedure to document the initial state of the extraction site packed with the CGF plug. Final Assessment: A follow-up CBCT scan is performed 3 months post-operatively.
The study measures the changes in density within the alveolar bone. It is evaluated using Cone-Beam Computed Tomography (CBCT), which provides 3D imaging of the surgical site. The density is quantified using Hounsfield units, a standardized scale for describing radiodensity in CT scans. An initial scan is taken immediately after surgery to establish a baseline of the empty socket packed with the CGF plug. A follow-up scan is taken 3 months post-operatively to measure the new bone formation.
A Cone-beam computed tomography (CBCT) scan is taken immediately after the surgical procedure to document the initial state of the extraction site packed with the CGF plug. Final Assessment: A follow-up CBCT scan is performed 3 months post-operatively.
Post Operative Pain
Time Frame: The time frame for the secondary outcome of Postoperative Pain consists of three specific measurement points during the first week after surgery: 1 day post-operatively 3 days post-operatively 7 days post-operatively
This outcome measures the intensity of subjective pain experienced by the participant following the surgical extraction of the impacted third molar. Pain is assessed using the Verbal Numeric Rating Scale (VNRS). This is a validated tool where the investigator asks the patient to rate their pain level. The score is recorded as a numerical value on a scale from 0 to 10, where 0 represents "no pain" and 10 represents the "worst imaginable pain".
The time frame for the secondary outcome of Postoperative Pain consists of three specific measurement points during the first week after surgery: 1 day post-operatively 3 days post-operatively 7 days post-operatively

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
  • Principal Investigator: Meshari Mohammed Aharbi, Cairo university
  • Study Chair: Khalid Elhayes, Professor, 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)

May 1, 2026

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

December 30, 2026

Study Registration Dates

First Submitted

March 17, 2026

First Submitted That Met QC Criteria

March 17, 2026

First Posted (Actual)

March 20, 2026

Study Record Updates

Last Update Posted (Actual)

April 8, 2026

Last Update Submitted That Met QC Criteria

April 2, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • omfs3-3-18

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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