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

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

The goal of this clinical trial is to learn if Concentrated Growth Factor (CGF) Gel 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 Gel into the extraction site improve bone density? Does the use of CGF Gel 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 Gel intervention rather than being compared to a placebo group.

Participants in this study will:

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

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

Have a CGF Gel 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: Impacted Lower Third Molar; Alveolar Bone Regeneration Following Odontectomy; Postoperative Pain Management in Oral Surgery; Concentrated Growth Factor for Extraction Socket Healing
• Intervention / Treatment: Other: Concentrated Growth Factor (CGF) Gel

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 "Gel" form. The CGF Gel 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 , 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 Gel 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

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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: CGF Gel 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) Gel 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) Gel; 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 packed into the fresh extraction socket to enhance healing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post Operative Pain	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 O 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
Bone Density	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 Gel. 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 Gel. Final Assessment: A follow-up CBCT scan is performed 3 months post-operatively.

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Chair: Khalid Elhayes, Professor, Cairo university; Study Director: Abdelmoez Mohammed El-Sharkawy, Associate Professor, Cairo university; Principal Investigator: Adel Barakat Aleadini, Bachelor of Dental Surgery, Cairo university

Study record dates

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 30, 2026
• First Submitted That Met QC Criteria: April 2, 2026
• First Posted (Actual): April 9, 2026

Study Record Updates

• Last Update Posted (Actual): April 9, 2026
• Last Update Submitted That Met QC Criteria: April 2, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Postoperative complications; Postoperative pain; Bone density; CGF; Bone regeneration; Third molar extraction; Surgical extraction; Concentrated growth factors; Extraction of lower 3rd molar
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative; Postoperative Complications; Pharmaceutical Preparations; Dosage Forms; Complex Mixtures; Colloids; Gels
• Other Study ID Numbers: omfs3-3-18-1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No