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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fawaz Shaya Alharbi | Contact | +230155132114 | fawaz.alharbi@dentistry.cu.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Fawaz Shaya Alharbi | Cairo University | Principal Investigator |
| Khalid Elhayes, professor | Cairo University | Study Chair |
| Abdelmoez Mohamed El-Sharkawy, Associate professor |
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| Cairo University |
| Study Director |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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