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

Official title

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

Overview

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.

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.

Interventions

• 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

Primary outcome measures

• 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]
• 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07517835 · omfs3-3-18-2

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗