Evaluation of the Use of CGF Based Sticky Bone Packed in Fresh Odontectomy Site of Impacted Lower 3rd Molars (CGF)

April 4, 2026 updated by: fawaz shaya alharbi, Cairo University

Clinical and Radiographic Evaluation of the Use of CGF Based Sticky Bone Packed in Fresh Odontectomy Site of Impacted Lower 3rd Molars

This clinical study aims to evaluate the effectiveness of Concentrated Growth Factor (CGF)-based sticky bone in enhancing bone healing after surgical removal of impacted mandibular third molars. Surgical extraction of impacted lower third molars is one of the most common procedures in oral and maxillofacial surgery and is often associated with postoperative complications such as pain, swelling, delayed healing, and bone defects within the extraction socket.

CGF is an autologous platelet concentrate derived from the patient's venous blood through a specific centrifugation process. It contains a high concentration of growth factors that play a key role in angiogenesis, tissue regeneration, and bone formation. When combined with particulate bone graft material, CGF forms a cohesive structure known as "sticky bone," which can provide both biological stimulation and structural support for bone regeneration.

In this study, CGF-based sticky bone will be placed into the fresh extraction socket immediately after surgical removal of the impacted mandibular third molar. Participants will be followed clinically and radiographically over a defined postoperative period. Clinical parameters such as pain intensity, soft tissue healing, and postoperative complications will be assessed, while radiographic analysis will be used to evaluate bone density and bone regeneration within the extraction site.

The findings of this study may contribute to improving regenerative techniques in oral and maxillofacial surgery and provide evidence regarding the potential benefits of CGF-based sticky bone in enhancing postoperative healing and bone regeneration following third molar extraction.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Preoperative Phase:

Consent Patient signs the informed consent form. Imaging

Cone-beam computed tomography (CBCT) is performed for:

Surgical planning Later comparison

Antiseptic Mouth Rinse Patient rinses with 0.12% chlorhexidine gluconate.

Surgical Procedure:

Operatory Setup All surgeries are done by the same oral surgeon. A sterilized operatory is used to maintain asepsis. Patient Preparation Pre-op instructions are given. Aseptic protocols followed. Sterile drapes placed. Anesthesia Topical anesthetic gel applied at injection site. Local anesthesia administered. Surgery begins only after anesthesia is confirmed effective. Surgical Access A mucoperiosteal flap is raised to expose the impacted lower third molar.

Tooth Removal Bone removal done using a high-speed surgical bur. Tooth extraction. Socket Cleaning

Socket is curetted to remove:

Granulation tissue Bone debris Tooth fragments Irrigated with sterile saline. CGF Based Sticky Bone Placement and Closure A CGF Based Sticky Bone is inserted into the socket. The wound is sutured using Vicryl sutures.

CGF (Concentrated Growth Factor) Preparation:

Blood Collection Blood drawn into a sterile 10 mL tube (no anticoagulant). Centrifugation Sample centrifuged using a CGF-specific machine. Tubes counterbalanced with another tube (blood or water). Clot Handling After centrifugation, CGF clot is removed. Red blood cell (RBC) layer is separated from fibrin matrix using a PRF tray. Sticky Bone Formation The CGF membrane is gently compressed using a sterile press to remove excess liquid.

The compressed CGF membrane is mixed thoroughly with bovine xenograft bone particles.

The mixture becomes cohesive and elastic, forming Sticky Bone, ready for surgical placement.

Postoperative Phase:

Medications Prescribed Antibiotic prophylaxis Analgesia medication Postoperative Instructions Standard care instructions are given to all patients. Pain Evaluation

Pain assessed using the Verbal Numeric Rating Scale (VNRS):

0 = No pain, 10 = Worst imaginable pain

Assessment on:

Day 1 Day 3 Day 7

Radiographic Evaluation:

Post-op Imaging

CBCT taken:

Immediately after surgery At 3 months post-op Purpose To assess changes in bone density over time.

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

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

No

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 Based Sticky Bone intervention group
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) membrane derived from the patient's own blood then its mixed thoroughly with bovine xenograft bone particles formed Sticky Bone 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 factors
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, CGF membrane is gently compressed using a sterile press to remove excess liquid. The compressed CGF membrane is mixed thoroughly with bovine xenograft bone particles.The mixture becomes cohesive and elastic, forming Sticky Bone, Then it is 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 Based Sticky Bone. Final Assessment: A follow-up CBCT scan is performed 3 months post-o
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 Based Sticky Bone . 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 Based Sticky Bone. Final Assessment: A follow-up CBCT scan is performed 3 months post-o
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
his outcome measures the intensity of subjective pain experienced by the participarnt 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

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: Khalid Elhayes, Professor, Cairo University
  • Principal Investigator: Fawaz Shaya Alharbi, 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)

April 25, 2026

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

October 15, 2026

Study Registration Dates

First Submitted

March 30, 2026

First Submitted That Met QC Criteria

April 4, 2026

First Posted (Actual)

April 8, 2026

Study Record Updates

Last Update Posted (Actual)

April 8, 2026

Last Update Submitted That Met QC Criteria

April 4, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • omfs3-3-18-2

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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