Evaluating The Use of CGF Made Gel in Mandibular Extraction Sites of Lower Impacted 3rd Molars.

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

About this trial

The goal of this clinical trial is to learn if Concentrated Growth Factor (CGF) Gel help improve bone healing and reduce pain after the surgical removal of impacted lower third molars. The study aims to answer the following:

Does packing CGF Gel into the extraction site improve bone density? Does the use of CGF Gel reduce postoperative pain for the patient? Researchers will evaluate the healing outcomes of patients receiving this treatment in a prospective case series study. Because this is a case series, all participants will receive the CGF Gel intervention rather than being compared to a placebo group.

Participants in this study will:

Undergo a blood draw to create the autologous CGF Gel from their own growth factors.

Undergo the surgical extraction of an impacted lower third molar under local anesthesia.

Have a CGF Gel placed in the extraction socket immediately following the tooth removal. Report their pain levels using a numeric scale on Day 1, Day 3, and Day 7 after surgery. Return for a follow-up CBCT scan three months after the procedure to evaluate bone density changes.

Eligibility criteria

This trial accepts 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 Factor (CGF) Gel

    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, which is then packed into the fresh extraction socket to enhance healing.

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: CGF Gel Intervention GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Post Operative Pain

This outcome measures the intensity of subjective pain experienced by the participant 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
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 Gel. 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 Gel. Final Assessment: A follow-up CBCT scan is performed 3 months post-operatively.

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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