Impacted Lower Third MolarCGFNCT07517835
Evaluation of the Use of CGF Based Sticky Bone Packed in Fresh Odontectomy Site of Impacted Lower 3rd Molars
A study testing Concentrated growth factors in people with Impacted Lower Third Molar and Alveolar Bone Regeneration Following Odontectomy, run by Cairo University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- 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 factors
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 25 Apr 2026to 15 Oct 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
- No healthy volunteers
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Clinical and Radiographic Evaluation of the Use of CGF Based Sticky Bone Packed in Fresh Odontectomy Site of Impacted Lower 3rd Molars
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.
Read more
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.
Read the detailed description
Preoperative Phase:
Consent Patient signs the informed consent form. Imaging
Cone-beam computed tomography (CBCT) is performed for:
Surgical planning Later comparison
Antiseptic Mouth Rinse Patient rinses with 0.12% chlorhexidine gluconate.
Surgical Procedure:
Operatory Setup All surgeries are done by the same oral surgeon. A sterilized operatory is used to maintain asepsis. Patient Preparation Pre-op instructions are given. Aseptic protocols followed. Sterile drapes placed. Anesthesia Topical anesthetic gel applied at injection site. Local anesthesia administered. Surgery begins only after anesthesia is confirmed effective. Surgical Access A mucoperiosteal flap is raised to expose the impacted lower third molar.
Tooth Removal Bone removal done using a high-speed surgical bur. Tooth extraction. Socket Cleaning
Socket is curetted to remove:
Granulation tissue Bone debris Tooth fragments Irrigated with sterile saline. CGF Based Sticky Bone Placement and Closure A CGF Based Sticky Bone is inserted into the socket. The wound is sutured using Vicryl sutures.
CGF (Concentrated Growth Factor) Preparation:
Blood Collection Blood drawn into a sterile 10 mL tube (no anticoagulant). Centrifugation Sample centrifuged using a CGF-specific machine. Tubes counterbalanced with another tube (blood or water). Clot Handling After centrifugation, CGF clot is removed. Red blood cell (RBC) layer is separated from fibrin matrix using a PRF tray. Sticky Bone Formation The 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, ready for surgical placement.
Postoperative Phase:
Medications Prescribed Antibiotic prophylaxis Analgesia medication Postoperative Instructions Standard care instructions are given to all patients. Pain Evaluation
Pain assessed using the Verbal Numeric Rating Scale (VNRS):
0 = No pain, 10 = Worst imaginable pain
Assessment on:
Day 1 Day 3 Day 7
Radiographic Evaluation:
Post-op Imaging
CBCT taken:
Immediately after surgery At 3 months post-op Purpose To assess changes in bone density over time.
- 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 factors
- Keywords
- Bone regeneration, Concentrated growth factors, Bone density, CGF, Surgical extraction, Extraction of lower 3rd molar, Third molar extraction, Postoperative complications, Postoperative pain
- 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 factorsOther
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
| Study group | Role | What they receive |
|---|---|---|
| CGF Based Sticky Bone intervention group | Experimental | 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) membrane derived from the patient's own blood then its mixed thoroughly with bovine xenograft bone particles formed Sticky Bone 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 factors |
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 Based Sticky Bone . 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 Based Sticky Bone. Final Assessment: A follow-up CBCT scan is performed 3 months post-o
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".
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 posted8 Apr 2026
- Study start25 Apr 2026 (estimated)
- Primary completion1 Sep 2026 (estimated)
- Study completion15 Oct 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, fawaz shaya alharbi, Cairo University
- Investigators
- Fawaz Shaya Alharbi, Principal investigator, Cairo UniversityKhalid Elhayes, professor, Study chair, Cairo UniversityAbdelmoez Mohamed El-Sharkawy, Associate professor, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07517835
- Sponsor's protocol ID
- omfs3-3-18-2
- Acronym
- CGF
- Status last verified
- Apr 2026
- First submitted
- 30 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 Based Sticky Bone Packed in Fresh Odontectomy Site of Impacted Lower 3rd Molars
- ClinicalTrials.gov ID
- NCT07517835
- Acronym / sponsor ID
- CGF / omfs3-3-18-2
- 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, Bone density, CGF, Surgical extraction, Extraction of lower 3rd molar, Third molar extraction, Postoperative complications
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 25 Apr 2026 (estimated)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 15 Oct 2026 (estimated)
- First posted
- 8 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 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.
Detailed description
Preoperative Phase:
Consent Patient signs the informed consent form. Imaging
Cone-beam computed tomography (CBCT) is performed for:
Surgical planning Later comparison
Antiseptic Mouth Rinse Patient rinses with 0.12% chlorhexidine gluconate.
Surgical Procedure:
Operatory Setup All surgeries are done by the same oral surgeon. A sterilized operatory is used to maintain asepsis. Patient Preparation Pre-op instructions are given. Aseptic protocols followed. Sterile drapes placed. Anesthesia Topical anesthetic gel applied at injection site. Local anesthesia administered. Surgery begins only after anesthesia is confirmed effective. Surgical Access A mucoperiosteal flap is raised to expose the impacted lower third molar.
Tooth Removal Bone removal done using a high-speed surgical bur. Tooth extraction. Socket Cleaning
Socket is curetted to remove:
Granulation tissue Bone debris Tooth fragments Irrigated with sterile saline. CGF Based Sticky Bone Placement and Closure A CGF Based Sticky Bone is inserted into the socket. The wound is sutured using Vicryl sutures.
CGF (Concentrated Growth Factor) Preparation:
Blood Collection Blood drawn into a sterile 10 mL tube (no anticoagulant). Centrifugation Sample centrifuged using a CGF-specific machine. Tubes counterbalanced with another tube (blood or water). Clot Handling After centrifugation, CGF clot is removed. Red blood cell (RBC) layer is separated from fibrin matrix using a PRF tray. Sticky Bone Formation The 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, ready for surgical placement.
Postoperative Phase:
Medications Prescribed Antibiotic prophylaxis Analgesia medication Postoperative Instructions Standard care instructions are given to all patients. Pain Evaluation
Pain assessed using the Verbal Numeric Rating Scale (VNRS):
0 = No pain, 10 = Worst imaginable pain
Assessment on:
Day 1 Day 3 Day 7
Radiographic Evaluation:
Post-op Imaging
CBCT taken:
Immediately after surgery At 3 months post-op Purpose To assess changes in bone density over time.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CGF Based Sticky Bone intervention group | Experimental | Other: Concentrated growth factorsParticipants 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) membrane derived from the patient's own blood then its mixed thoroughly with bovine xenograft bone particles formed Sticky Bone 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
- Not 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 factorsThis 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 | Other | CGF Based Sticky Bone 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 Based Sticky Bone. Final Assessment: A follow-up CBCT scan is performed 3 months post-o
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.
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
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".
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.
Fawaz Shaya Alharbi principal investigator
Cairo University
Khalid Elhayes, professor study chair
Cairo University
Abdelmoez Mohamed El-Sharkawy, Associate professor study director
Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing Concentrated growth factors 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?
Contact Fawaz Shaya Alharbi (+230155132114, fawaz.alharbi@dentistry.cu.edu.eg), or a site near the patient. 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 Based Sticky Bone. Final Assessment: A follow-up CBCT scan is performed 3 months post-o). 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.