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

NCT07520097 | Not Yet Recruiting

• 1 other identifier: omfs3-3-18-1
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Postoperative Pain Management in Oral Surgery; Impacted Lower Third Molar; Alveolar Bone Regeneration Following Odontectomy; Concentrated Growth Factor for Extraction Socket Healing

Keywords

Bone regeneration; Concentrated growth factors; CGF; Postoperative complications; Postoperative pain; Third molar extraction; Extraction of lower 3rd molar; Surgical extraction; Bone density

Outcome Measures

Primary Outcomes (2)

• 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.

Study Arms (1)

CGF Gel Intervention Group

EXPERIMENTAL

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

Interventions

Concentrated Growth Factor (CGF) Gel OTHER

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.

CGF Gel Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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 .

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Postoperative Complications; Pain, Postoperative

Interventions

Gels

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Khalid Elhayes, Professor

  Cairo University

  STUDY CHAIR

• Abdelmoez Mohammed El-Sharkawy, Associate Professor

  Cairo University

  STUDY DIRECTOR

• Adel Barakat Aleadini, Bachelor of Dental Surgery

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: March 30, 2026
• First Posted: April 9, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: April 9, 2026

Record last verified: 2026-04