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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCairo University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients aged 18 years or older

Both male and female patients

Patients requiring odontectomy of an impacted lower third molar

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Concentrated growth factors

    Other intervention

    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

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: CGF Based Sticky Bone intervention groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

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
2

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".

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

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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