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

NCT07517835 | Not Yet Recruiting

• 1 other identifier: omfs3-3-18-2
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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 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

  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

Study Arms (1)

CGF Based Sticky Bone intervention group

EXPERIMENTAL

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

Interventions

Concentrated growth factors 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, 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

CGF Based Sticky Bone intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• 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

Condition Hierarchy (Ancestors)

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

Study Officials

• Fawaz Shaya Alharbi

  Cairo University

  PRINCIPAL INVESTIGATOR

• Khalid Elhayes, professor

  Cairo University

  STUDY CHAIR

• Abdelmoez Mohamed El-Sharkawy, Associate professor

  Cairo University

  STUDY DIRECTOR

Central Study Contacts

Fawaz Shaya Alharbi

CONTACT

+230155132114; fawaz.alharbi@dentistry.cu.edu.eg

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 8, 2026
• Study Start: April 25, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): October 15, 2026
• Last Updated: April 8, 2026

Record last verified: 2026-04