Evaluating The Use of CGF Plugs in Fresh Odontectomy Socket.

NCT07542795 | Not Yet Recruiting

• 1 other identifier: omfs 3-3-18-5
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the use of Concentrated Growth Factor (CGF) plugs-a third-generation healing material made from the patient's own blood-to improve recovery after simple tooth extractions. CGF contains a dense matrix of growth factors and regenerative cells designed to enhance wound healing and tissue regeneration. Participants requiring a single, non-surgical tooth extraction will have a CGF plug placed into the empty socket immediately following the procedure. The researchers will then monitor two main factors:

• Post-operative Pain: Patients will record their pain levels on a scale of 0 to 10 at 1, 3, and 7 days after the extraction.
• Bone Density: Using specialized imaging (CBCT), the researchers will measure how well the bone heals and fills the socket immediately after the procedure and again at 3 months. The goal of this research is to determine if CGF plugs can effectively reduce patient discomfort and help preserve bone density, which is critical for future dental treatments like implants.

Conditions

Odontectomy (Tooth Extraction); Socket Preservation and Healing Following Simple, Non-surgical Extraction; Alveolar Bone Density and Postoperative Pain Management; Periapical Radiolucency

Keywords

Concentrated Growth Factor (CGF); CGF Plug; Odontectomy; Tooth Extraction; Socket Preservation; Bone Density; Postoperative Pain; Alveolar Bone; Platelet Concentrates

Outcome Measures

Primary Outcomes (2)

• Bone Density

  Evaluation of the extraction socket using Cone-beam computed tomography (CBCT) to assess changes in bone healing and preservation. Measurements are specifically analyzed and recorded using the Hounsfield unit scale to quantify mineral density within the site.

  Baseline assessment is conducted immediately after the tooth extraction and CGF plug placement, with a follow-up assessment performed at 3 months postoperatively.

• Post Operative Pain

  Clinical evaluation of pain using the Verbal Numeric Rating Scale (VNRS), where participants rate their pain on a scale from 0 to 10 (0 = No pain, 10 = Worst imaginable pain).

  Assessments are conducted at three specific intervals: Day 1, Day 3, and Day 7 following the surgical procedure.

Study Arms (1)

CGF Plug Intervention Group

EXPERIMENTAL

This arm involves patients requiring simple, non-surgical extraction of a single tooth. Following an atraumatic extraction and socket curettage, a Concentrated Growth Factor (CGF) plug is packed into the fresh odontectomy site. The CGF plug is prepared by centrifuging 10 mL of the patient's own blood using a specialized variable-speed protocol to create a dense fibrin matrix. After the plug is inserted, the wound is secured with Vicryl sutures. Participants in this arm are evaluated for changes in bone density via CBCT imaging and for postoperative pain using the Verbal Numeric Rating Scale (VNRS).

Other: Concentrated Growth Factor (CGF) Plug

Interventions

Concentrated Growth Factor (CGF) Plug OTHER

The intervention involves preparing an autologous Concentrated Growth Factor (CGF) plug from the patient's blood using variable-speed centrifugation and placing it into a fresh, curetted extraction socket to evaluate its impact on bone density and postoperative pain.

CGF Plug Intervention Group

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Systemically healthy patients (ASA I or II)
• Age between 20 and 50 years
• Require simple, non-surgical extraction of a single tooth
• Presence of periapical radiolucency at the extraction site
• Willingness to comply with follow-up and provide signed informed consent

You may not qualify if:

• Systemic diseases (e.g., uncontrolled diabetes, bone metabolic disorders)
• History of radiotherapy or chemotherapy
• Use of medications affecting bone metabolism (e.g., bisphosphonates, chronic steroids)
• Heavy smokers
• Pregnant or lactating women
• Poor oral hygiene or active acute infection/suppuration at the site

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University Faculty of Dentistry

Cairo, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

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

Study Officials

• Hisham Sayed, Professor

  Cairo University

  STUDY CHAIR

• Abdelmoez Mohamed El-Sharkawy, Associate Professor

  Cairo University

  STUDY DIRECTOR

• Aziz Taysir Haydar

  Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aziz Taysir Haydar

CONTACT

+201080823761; Zizoaziz66@gmail.com

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: April 15, 2026
• First Posted: April 21, 2026
• Study Start (Estimated): September 28, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: April 21, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)