Odontectomy (Tooth Extraction)CGFNCT07542795
Evaluating The Use of CGF Plugs in Fresh Odontectomy Socket.
A study testing Concentrated Growth Factor (CGF) Plug in people with Odontectomy (Tooth Extraction) and Socket Preservation and Healing Following Simple, Non-surgical Extraction, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Odontectomy (Tooth Extraction), Socket Preservation and Healing Following Simple, Non-surgical Extraction, Alveolar Bone Density and Postoperative Pain Management
- What is being tested?
- Concentrated Growth Factor (CGF) Plug
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- 28 Sep 2026to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- • 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Cairo University Faculty of Dentistry
Cairo
Aziz Taysir Haydar, +201080823761 ext. +966550484556, Zizoaziz66@gmail.com
About this study
Official title: Clinical and Radiographic Evaluation of the Use of CGF Plugs Packed in Fresh Odontectomy Socket (Case Series Study)
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:
Read more
- 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.
Read the detailed description
Study Design and Setting This study is a prospective case series conducted in a minor surgery setting. The trial evaluates the clinical and radiographic outcomes of using Concentrated Growth Factor (CGF) plugs in fresh extraction sockets following simple, non-surgical tooth extractions.
Intervention and CGF Preparation
The surgical intervention follows a standardized protocol:
- Preoperative Phase: Patients provide written informed consent. They perform a 0.12% chlorhexidine gluconate mouth rinse and receive baseline imaging via Cone-beam computed tomography (CBCT) for extraction site evaluation.
- CGF Preparation: 10 mL of blood is drawn into a sterile tube without anticoagulants. This is centrifuged using a CGF-specific machine. The CGF clot is separated from the red blood cells, placed in a plug mold, and compressed into a stable plug using a PRF tray.
- Surgical Procedure: Under local anesthesia, an atraumatic extraction is performed using forceps and elevators to avoid damage to socket walls. The socket is curetted to remove granulation tissue and tooth fragments, then irrigated with sterile saline. The CGF plug is inserted into the socket, which is then sutured using Vicryl.
Outcome Assessment
The study focuses on two main recovery indicators:
- Radiographic Evaluation (Primary): CBCT scans are taken immediately after extraction and at 3 months post-op to assess changes in bone density over time. These measurements are recorded in Hounsfield units.
- Clinical Evaluation (Secondary): Postoperative pain is assessed using the Verbal Numeric Rating Scale (VNRS), where 0 represents "No pain" and 10 represents "Worst imaginable pain". Assessments are conducted on Day 1, Day 3, and Day 7.
Data Management and Monitoring All study data is entered electronically. Patients' files are stored in numerical order in a secure and accessible place, with data maintained in storage for one year after the completion of the study. Data entry is transmitted from the assessor to a database officer as blind separate datasheets before being recorded in a participant chart. Access to study data is restricted to the database officer, and a complete backup of the primary database is performed twice a month.
Safety and Ethics Intraoperative and postoperative harms, such as excessive bleeding or infection, are managed through atraumatic techniques, sterile protocols, and prescribed medications including antibiotics and analgesics. Any modifications to the protocol that may impact the conduct of the study or patient safety require a formal amendment agreed upon by the department council.
- Conditions
- Odontectomy (Tooth Extraction), Socket Preservation and Healing Following Simple, Non-surgical Extraction, Alveolar Bone Density and Postoperative Pain Management, Periapical Radiolucency
- Being tested
- Concentrated Growth Factor (CGF) Plug
- Keywords
- Concentrated Growth Factor (CGF), CGF Plug, Odontectomy, Tooth Extraction, Socket Preservation, Bone Density, Postoperative Pain, Alveolar Bone, Platelet Concentrates
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Concentrated Growth Factor (CGF) PlugOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: Concentrated Growth Factor (CGF) Plug |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: Assessments are conducted at three specific intervals: Day 1, Day 3, and Day 7 following the surgical procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2026
- Study start28 Sep 2026 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Odontectomy (Tooth Extraction)Studies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aziz Taysir Haydar, Cairo University
- Investigators
- Hisham Sayed, Professor, Study chair, Cairo UniversityAbdelmoez Mohamed El-Sharkawy, Associate Professor, Study director, Cairo UniversityAziz Taysir Haydar, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07542795
- Sponsor's protocol ID
- omfs 3-3-18-5
- Acronym
- CGF
- Status last verified
- Mar 2026
- First submitted
- 15 Apr 2026
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Evaluation of the Use of CGF Plugs Packed in Fresh Odontectomy Socket (Case Series Study)
- ClinicalTrials.gov ID
- NCT07542795
- Acronym / sponsor ID
- CGF / omfs 3-3-18-5
- 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
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 28 Sep 2026 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 21 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study Design and Setting This study is a prospective case series conducted in a minor surgery setting. The trial evaluates the clinical and radiographic outcomes of using Concentrated Growth Factor (CGF) plugs in fresh extraction sockets following simple, non-surgical tooth extractions.
Intervention and CGF Preparation
The surgical intervention follows a standardized protocol:
- Preoperative Phase: Patients provide written informed consent. They perform a 0.12% chlorhexidine gluconate mouth rinse and receive baseline imaging via Cone-beam computed tomography (CBCT) for extraction site evaluation.
- CGF Preparation: 10 mL of blood is drawn into a sterile tube without anticoagulants. This is centrifuged using a CGF-specific machine. The CGF clot is separated from the red blood cells, placed in a plug mold, and compressed into a stable plug using a PRF tray.
- Surgical Procedure: Under local anesthesia, an atraumatic extraction is performed using forceps and elevators to avoid damage to socket walls. The socket is curetted to remove granulation tissue and tooth fragments, then irrigated with sterile saline. The CGF plug is inserted into the socket, which is then sutured using Vicryl.
Outcome Assessment
The study focuses on two main recovery indicators:
- Radiographic Evaluation (Primary): CBCT scans are taken immediately after extraction and at 3 months post-op to assess changes in bone density over time. These measurements are recorded in Hounsfield units.
- Clinical Evaluation (Secondary): Postoperative pain is assessed using the Verbal Numeric Rating Scale (VNRS), where 0 represents "No pain" and 10 represents "Worst imaginable pain". Assessments are conducted on Day 1, Day 3, and Day 7.
Data Management and Monitoring All study data is entered electronically. Patients' files are stored in numerical order in a secure and accessible place, with data maintained in storage for one year after the completion of the study. Data entry is transmitted from the assessor to a database officer as blind separate datasheets before being recorded in a participant chart. Access to study data is restricted to the database officer, and a complete backup of the primary database is performed twice a month.
Safety and Ethics Intraoperative and postoperative harms, such as excessive bleeding or infection, are managed through atraumatic techniques, sterile protocols, and prescribed medications including antibiotics and analgesics. Any modifications to the protocol that may impact the conduct of the study or patient safety require a formal amendment agreed upon by the department council.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CGF Plug Intervention Group | Experimental | Other: Concentrated Growth Factor (CGF) PlugThis 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). |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- • Systemic diseases (e.g., uncontrolled diabetes, bone metabolic disorders)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Concentrated Growth Factor (CGF) PlugThe 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. | Other | CGF Plug Intervention Group |
Primary outcome
Bone Density
Time frame: Baseline assessment is conducted immediately after the tooth extraction and CGF plug placement, with a follow-up assessment performed at 3 months postoperatively.
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.
Post Operative Pain
Time frame: Assessments are conducted at three specific intervals: Day 1, Day 3, and Day 7 following the surgical procedure.
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Odontectomy (Tooth Extraction)
Not yet recruiting
Effect of Ascorbic Acid-Loaded I-PRF With Partially Demineralized Dentin Graft on Alveolar Ridge Preservation
Alveolar Ridge Preservation Post-Extraction Bone Healing Dental Implant Site Development Tooth Loss, Alveolar Bone Regeneration Following Odontectomy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hisham Sayed, Professor study chair
Cairo University
Abdelmoez Mohamed El-Sharkawy, Associate Professor study director
Cairo University
Aziz Taysir Haydar principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Concentrated Growth Factor (CGF) Plug in people with Odontectomy (Tooth Extraction) and Socket Preservation and Healing Following Simple, Non-surgical Extraction, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aziz Taysir Haydar (+201080823761 ext. +966550484556, Zizoaziz66@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone Density (time frame: Baseline assessment is conducted immediately after the tooth extraction and CGF plug placement, with a follow-up assessment performed at 3 months postoperatively.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.