Impacted Lower Third MolarCGFNCT07484997
Evaluating The Use of CGF Made Plugs in Mandibular Extraction Sites of Lower Impacted 3rd Molars.
A study testing Concentrated Growth Factor (CGF) Plug in people with Impacted Lower Third Molar and Alveolar Bone Regeneration Following Odontectomy, run by Cairo University.
Trial summary
The goal of this clinical trial is to learn if Concentrated Growth Factor (CGF) plugs help improve bone healing and reduce pain after the surgical removal of impacted lower third molars. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Impacted Lower Third Molar, Alveolar Bone Regeneration Following Odontectomy, Postoperative Pain Management in Oral Surgery
- 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
- No sites listed yet
- Study dates
- 1 May 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients aged 18 years or older
- Both male and female patients
- Patients requiring odontectomy of an impacted lower third molar
Who cannot join
- 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
About this study
Official title: Clinical and Radiographic Evaluation of The Use of CGF Plugs Packed in Fresh Odontectomy Site of Impacted Lower 3rd Molars (Case Series Study)
The goal of this clinical trial is to learn if Concentrated Growth Factor (CGF) plugs help improve bone healing and reduce pain after the surgical removal of impacted lower third molars.
The study aims to answer the following:
Read more
Does packing CGF plugs into the extraction site improve bone density? Does the use of CGF plugs 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 plug intervention rather than being compared to a placebo group.
Participants in this study will:
Undergo a blood draw to create the autologous CGF plug from their own growth factors.
Undergo the surgical extraction of an impacted lower third molar under local anesthesia.
Have a CGF plug 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.
Read the detailed description
The surgical removal of impacted lower third molars, commonly known as wisdom teeth, is one of the most frequent procedures in oral surgery. While routine, this procedure often leads to significant postoperative challenges, including pain and substantial bone loss in the extraction area. This bone loss can compromise the health of the adjacent teeth and the surrounding periodontal tissue.
To improve healing outcomes, this study investigates the use of Concentrated Growth Factor (CGF). CGF is a third-generation autologous platelet concentrate-meaning it is derived from the patient's own blood. Unlike earlier versions like PRP or PRF, CGF is created using a specialized variable-speed centrifugation process that results in a denser fibrin matrix. This matrix is rich in growth factors and regenerative cells, which may offer superior mechanical properties and a more sustained release of healing factors to promote bone regeneration and reduce pain.
The researchers aims to evaluate the clinical and radiographic effectiveness of using CGF in a "plug" form. The CGF plug is valued for its stability and ease of handling within the surgical site. The study specifically looks at:
Bone Density Improvement: Measuring how well the extraction site fills with new bone over three months.
Pain Management: Assessing whether the biological properties of CGF can lower the intensity of pain experienced by patients in the week following surgery.
On the day of surgery, the Principal Investigator will collect a small sample (10mL) of the participant's blood into a sterile tube without anticoagulants. This sample is then processed in a centrifugation machine under dedicated CGF extraction settings. Once the blood has been separated, the resulting fibrin clot is removed and placed into a specialized mold to compress it into a stable "plug" shape, ready for immediate placement into the tooth socket.
All surgeries will be performed under local anesthesia in a sterile minor surgery setting. After ensuring the area is fully anesthetized, the Principal Investigator will Carefully remove the impacted wisdom tooth using standard surgical techniques.
Clean the extraction socket to remove any debris or fragments. Pack the prepared CGF plug directly into the fresh extraction site. Suture the wound closed using absorbable sutures.
Following the procedure, the Principal Investigator will monitor the participants' recovery through two primary parameters:
Pain Assessment: Participants will record their pain levels using the Verbal Numeric Rating Scale (VNRS), where 0 represents no pain and 10 represents the worst imaginable pain. These assessments occur on Day 1, Day 3, and Day 7 post-surgery.
Radiographic Evaluation: To measure bone healing, Cone-Beam Computed Tomography (CBCT) scans will be taken immediately after surgery and again at 3 months. These scans allow for the calculation of changes in bone density using Hounsfield units.
The study is conducted with strict adherence to patient safety and ethical standards. Any potential risks, such as postoperative infection or bleeding, will be managed through prophylactic antibiotics, sterile protocols, and clear emergency contact instructions. Participation is voluntary, and all participants must provide written informed consent before the study begins.
- Conditions
- Impacted Lower Third Molar, Alveolar Bone Regeneration Following Odontectomy, Postoperative Pain Management in Oral Surgery, Concentrated Growth Factor for Extraction Socket Healing
- Being tested
- Concentrated Growth Factor (CGF) Plug
- Keywords
- Bone regeneration, Concentrated growth factors, Postoperative complications, Postoperative pain, Third molar extraction, Extraction of lower 3rd molar, Surgical extraction, CGF, Bone density
- Medical subject headings
- Postoperative Complications, 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
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 molded into a plug form and packed into the fresh extraction socket to enhance healing.
| Study group | Role | What they receive |
|---|---|---|
| CGF Plug Intervention Group | Experimental | This is a single-arm, prospective study where all participants receive the same intervention. Participants requiring the surgical removal of an impacted lower third molar will undergo a standard odontectomy procedure under local anesthesia. Immediately following the tooth extraction, a prepared autologous Concentrated Growth Factor (CGF) plug derived from the patient's own blood is packed into the fresh extraction socket. The site is then sutured. The arm focuses on evaluating the subsequent healing process, specifically monitoring postoperative pain levels during the first week and measuring changes in alveolar bone density via CBCT scans at a three month follow up. 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
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 plug. A follow-up scan is taken 3 months post-operatively to measure the new bone formation.
Measured: 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 plug. Final Assessment: A follow-up CBCT scan is performed 3 months post-operatively.
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 0 represents "no pain" and 10 represents the "worst imaginable pain".
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2026
- Study start1 May 2026 (estimated)
- Primary completion1 Sep 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 Impacted Lower Third MolarStudies 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, MESHARI MOHAMMED ALHARBI, Cairo University
- Investigators
- Abdelmoez Mohamed El-Sharkawy, Associate Professor, Study director, Cairo UniversityMeshari Mohammed Aharbi, Principal investigator, Cairo UniversityKhalid Elhayes, Professor, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07484997
- Sponsor's protocol ID
- omfs3-3-18
- Acronym
- CGF
- Status last verified
- Mar 2026
- First submitted
- 17 Mar 2026
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 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 Site of Impacted Lower 3rd Molars (Case Series Study)
- ClinicalTrials.gov ID
- NCT07484997
- Acronym / sponsor ID
- CGF / omfs3-3-18
- Conditions
- Impacted Lower Third Molar, Alveolar Bone Regeneration Following Odontectomy, Postoperative Pain Management in Oral Surgery, Concentrated Growth Factor for Extraction Socket Healing
- Keywords
- Bone regeneration, Concentrated growth factors, Postoperative complications, Postoperative pain, Third molar extraction, Extraction of lower 3rd molar, Surgical extraction, CGF
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 20 Mar 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.
The goal of this clinical trial is to learn if Concentrated Growth Factor (CGF) plugs 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 plugs into the extraction site improve bone density? Does the use of CGF plugs 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 plug intervention rather than being compared to a placebo group.
Participants in this study will:
Undergo a blood draw to create the autologous CGF plug from their own growth factors.
Undergo the surgical extraction of an impacted lower third molar under local anesthesia.
Have a CGF plug 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.
Detailed description
The surgical removal of impacted lower third molars, commonly known as wisdom teeth, is one of the most frequent procedures in oral surgery. While routine, this procedure often leads to significant postoperative challenges, including pain and substantial bone loss in the extraction area. This bone loss can compromise the health of the adjacent teeth and the surrounding periodontal tissue.
To improve healing outcomes, this study investigates the use of Concentrated Growth Factor (CGF). CGF is a third-generation autologous platelet concentrate-meaning it is derived from the patient's own blood. Unlike earlier versions like PRP or PRF, CGF is created using a specialized variable-speed centrifugation process that results in a denser fibrin matrix. This matrix is rich in growth factors and regenerative cells, which may offer superior mechanical properties and a more sustained release of healing factors to promote bone regeneration and reduce pain.
The researchers aims to evaluate the clinical and radiographic effectiveness of using CGF in a "plug" form. The CGF plug is valued for its stability and ease of handling within the surgical site. The study specifically looks at:
Bone Density Improvement: Measuring how well the extraction site fills with new bone over three months.
Pain Management: Assessing whether the biological properties of CGF can lower the intensity of pain experienced by patients in the week following surgery.
On the day of surgery, the Principal Investigator will collect a small sample (10mL) of the participant's blood into a sterile tube without anticoagulants. This sample is then processed in a centrifugation machine under dedicated CGF extraction settings. Once the blood has been separated, the resulting fibrin clot is removed and placed into a specialized mold to compress it into a stable "plug" shape, ready for immediate placement into the tooth socket.
All surgeries will be performed under local anesthesia in a sterile minor surgery setting. After ensuring the area is fully anesthetized, the Principal Investigator will Carefully remove the impacted wisdom tooth using standard surgical techniques.
Clean the extraction socket to remove any debris or fragments. Pack the prepared CGF plug directly into the fresh extraction site. Suture the wound closed using absorbable sutures.
Following the procedure, the Principal Investigator will monitor the participants' recovery through two primary parameters:
Pain Assessment: Participants will record their pain levels using the Verbal Numeric Rating Scale (VNRS), where 0 represents no pain and 10 represents the worst imaginable pain. These assessments occur on Day 1, Day 3, and Day 7 post-surgery.
Radiographic Evaluation: To measure bone healing, Cone-Beam Computed Tomography (CBCT) scans will be taken immediately after surgery and again at 3 months. These scans allow for the calculation of changes in bone density using Hounsfield units.
The study is conducted with strict adherence to patient safety and ethical standards. Any potential risks, such as postoperative infection or bleeding, will be managed through prophylactic antibiotics, sterile protocols, and clear emergency contact instructions. Participation is voluntary, and all participants must provide written informed consent before the study begins.
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 is a single-arm, prospective study where all participants receive the same intervention. Participants requiring the surgical removal of an impacted lower third molar will undergo a standard odontectomy procedure under local anesthesia. Immediately following the tooth extraction, a prepared autologous Concentrated Growth Factor (CGF) plug derived from the patient's own blood is packed into the fresh extraction socket. The site is then sutured. The arm focuses on evaluating the subsequent healing process, specifically monitoring postoperative pain levels during the first week and measuring changes in alveolar bone density via CBCT scans at a three month follow up. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged 18 years or older
- Both male and female patients
- Patients requiring odontectomy of an impacted lower third molar
Key exclusion criteria (7 listed)
- 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
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) PlugThis 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 molded into a plug form and packed into the fresh extraction socket to enhance healing. | Other | CGF Plug Intervention Group |
Primary outcome
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 plug. Final Assessment: A follow-up CBCT scan is performed 3 months post-operatively.
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 plug. A follow-up scan is taken 3 months post-operatively to measure the new bone formation.
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
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 0 represents "no pain" and 10 represents the "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 8 Apr 2026.
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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.
Abdelmoez Mohamed El-Sharkawy, Associate Professor study director
Cairo University
Meshari Mohammed Aharbi principal investigator
Cairo University
Khalid Elhayes, Professor study chair
Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing Concentrated Growth Factor (CGF) Plug in people with Impacted Lower Third Molar and Alveolar Bone Regeneration Following Odontectomy, run by Cairo University.
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 3 inclusion and 7 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 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 plug. Final Assessment: A follow-up CBCT scan is performed 3 months post-operatively.). 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 8 Apr 2026.