Alveolar Bone LossCGFNCT07521514
Evaluation of Guided Tissue Regeneration With Autogenous Bone Chips and CGF During Implant Placement
A study testing concentrated growth factor (CGF) Membrane in people with Alveolar Bone Loss and Alveolar Ridge Augmentation, run by Cairo University at 1 site in Egypt.
Trial summary
CGF membranes will be prepared using a swing-lock centrifuge. A full-thickness mucoperiosteal flap will be elevated in a narrow alveolar ridge. Implants will be inserted. Autologous bone chips will be harvested via bone scraping and used for augmentation, CGF membranes will be placed over the grafted area. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alveolar Bone Loss, Alveolar Ridge Augmentation, Dental Implant
- What is being tested?
- concentrated growth factor (CGF) Membrane
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteEgypt
- Study dates
- 16 Apr 2026to 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
- A medical history that contraindicates oral surgical treatment such as (uncontrolled/untreated diabetes mellitus, immuno-compromised status, radio or chemotherapy of the oral and maxillofacial region, treatment with oral and/or intravenous bisphosphonates).
- Presence of active or untreated periodontal disease.
- Vertical root fractures involving the buccal aspect.
- Tooth /teeth with horizontal fractures below bone level.
- Tooth /teeth with external or internal resorption.
- Patients with destructive oral habits such as smoking, chewing tobacco, bruxism,etcetera(Chrcanovic et al., 2014).
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- exclusion criteria: A medical history that contraindicates oral surgical treatment such as (uncontrolled/untreated diabetes mellitus, immuno-compromised status, radio or chemotherapy of the oral and maxillofacial region, treatment with oral and/or intravenous bisphosphonates).
- Presence of active or untreated periodontal disease.
- Vertical root fractures involving the buccal aspect.
- Tooth /teeth with horizontal fractures below bone level.
- Tooth /teeth with external or internal resorption.
- Patients with destructive oral habits such as smoking, chewing tobacco, bruxism, etcetera(Chrcanovic et al., 2014).
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
meis youssef moustafa, bachelors contact
About this study
Official title: Clinical and Radiographic Evaluation of Guided Tissue Regeneration Using Autogenous Bone Chips and Concentrated Growth Factors Membranes With Simultaneous Implant Placement. (Case Series)
CGF membranes will be prepared using a swing-lock centrifuge. A full-thickness mucoperiosteal flap will be elevated in a narrow alveolar ridge. Implants will be inserted. Autologous bone chips will be harvested via bone scraping and used for augmentation, CGF membranes will be placed over the grafted area. Suturing of the mucoperiosteal flap. Radiographic evaluation of the bone density and tissue thickness will be performed by CBCT preoperatively, immediate postoperative and after the procedure by 4 months. Clinical evaluation of the tissue thickness using periodontal probe preoperatively, immediate postoperatively and after the procedure by 4 months
Read the detailed description
- Preoperative cone-beam computed tomography (CBCT) images will be obtained for surgical planning and for later comparison during follow-up evaluations.
- Clinical evaluation of the tissue thickness using periodontal probe
- Signed consent from the patient agreeing to the procedure
- All surgical procedures will be performed by the same oral surgeon, following a standardized protocol to ensure consistency. The surgeries will be conducted in a sterilized dental operatory prepared specifically for oral surgery.
- Patient preparation will include preoperative instructions and aseptic measures.
Sterile drapes will be placed to minimize contamination.
- The patient will be prepared for phlebotomy, and a blood sample will be drawn into a sterile 10 mL tube without anticoagulant. The sample will be immediately centrifuged using a CGF-specific centrifuge under the designated CGF settings. To ensure proper balance during centrifugation, each tube will be counterbalanced with another tube containing either blood or water. After centrifugation is complete, the tubes will be removed, and the CGF clot will be carefully extracted. Using a PRF preparation tray, the red blood cell (RBC) layer will be separated from the fibrin matrix. The remaining CGF membrane will be ready for use.
- Prior to surgery, the patient will rinse with 0.12% chlorhexidine gluconate as an antiseptic mouthwash. A topical anesthetic gel will be applied to the injection site prior to the administration of local anesthesia. Once both subjective and objective signs of anesthesia are confirmed, a mucoperiosteal flap will be elevated in a narrow alveolar ridge.
- Autologous bone chips will be harvested via bone scraping and used for augmentation.
- Implants will be inserted.
- CGF membranes will be placed over the grafted area.
- Interrupted sutures will be performed. Radiographic evaluation of the bone density and tissue thickness will be performed by CBCT, immediate postoperative and after the procedure by 4 months. Clinical evaluation of the tissue thickness using periodontal probe immediate postoperatively and after the procedure by 4 months.
- Being tested
- concentrated growth factor (CGF) Membrane
- Keywords
- CGF, autogenous bone graft, gingival biotype, dental implant, guided tissue regeneration
- Medical subject headings
- Alveolar Bone Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
concentrated growth factor (CGF) MembraneOther
This is a third-generation autologous blood concentrate prepared using a dedicated centrifuge system. The process creates a fibrin-rich organic matrix from the patient's own blood, which is then molded into a membrane and packed over the grafted bone to enhance bone density increase and improvement of the surrounding tissue.
| Study group | Role | What they receive |
|---|---|---|
| GTR with Autogenous Bone Chips and CGF Membrane | Other | Not described Receives: Other: concentrated growth factor (CGF) Membrane |
What is being measured
The primary outcome is the main question the study is designed to answer.
tissue biotype
using periodontal probe to measure gingival thickness
Measured: preoperative, immediate postoperative and 4 months after the procedure
Secondary outcomes (2)
bone density
cbct xray
Measured: preoperative, immediately postoperative, and 4 months after the surgery
patient satisfaction
psq18 is a chart where the patient describes the level of their satisfaction
Measured: after 4 months from the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start16 Apr 2026 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar Bone LossStudies 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
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meis Youssef Moustafa, Cairo University
- Investigators
- Hesham Elsayed Elhawary, Professor, Study chair, Cairo UniversityAbdelmoez Mohamed El-Sharkawy, Assistant Professor, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07521514
- Sponsor's protocol ID
- omfs3-3-20
- Acronym
- CGF
- Status last verified
- Mar 2026
- First submitted
- 3 Apr 2026
- Last updated
- 13 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 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Evaluation of Guided Tissue Regeneration Using Autogenous Bone Chips and Concentrated Growth Factors Membranes With Simultaneous Implant Placement. (Case Series)
- ClinicalTrials.gov ID
- NCT07521514
- Acronym / sponsor ID
- CGF / omfs3-3-20
- Keywords
- CGF, autogenous bone graft, gingival biotype, dental implant, guided tissue regeneration
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 16 Apr 2026 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 13 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.
CGF membranes will be prepared using a swing-lock centrifuge. A full-thickness mucoperiosteal flap will be elevated in a narrow alveolar ridge. Implants will be inserted. Autologous bone chips will be harvested via bone scraping and used for augmentation, CGF membranes will be placed over the grafted area. Suturing of the mucoperiosteal flap. Radiographic evaluation of the bone density and tissue thickness will be performed by CBCT preoperatively, immediate postoperative and after the procedure by 4 months. Clinical evaluation of the tissue thickness using periodontal probe preoperatively, immediate postoperatively and after the procedure by 4 months
Detailed description
- Preoperative cone-beam computed tomography (CBCT) images will be obtained for surgical planning and for later comparison during follow-up evaluations.
- Clinical evaluation of the tissue thickness using periodontal probe
- Signed consent from the patient agreeing to the procedure
- All surgical procedures will be performed by the same oral surgeon, following a standardized protocol to ensure consistency. The surgeries will be conducted in a sterilized dental operatory prepared specifically for oral surgery.
- Patient preparation will include preoperative instructions and aseptic measures.
Sterile drapes will be placed to minimize contamination.
- The patient will be prepared for phlebotomy, and a blood sample will be drawn into a sterile 10 mL tube without anticoagulant. The sample will be immediately centrifuged using a CGF-specific centrifuge under the designated CGF settings. To ensure proper balance during centrifugation, each tube will be counterbalanced with another tube containing either blood or water. After centrifugation is complete, the tubes will be removed, and the CGF clot will be carefully extracted. Using a PRF preparation tray, the red blood cell (RBC) layer will be separated from the fibrin matrix. The remaining CGF membrane will be ready for use.
- Prior to surgery, the patient will rinse with 0.12% chlorhexidine gluconate as an antiseptic mouthwash. A topical anesthetic gel will be applied to the injection site prior to the administration of local anesthesia. Once both subjective and objective signs of anesthesia are confirmed, a mucoperiosteal flap will be elevated in a narrow alveolar ridge.
- Autologous bone chips will be harvested via bone scraping and used for augmentation.
- Implants will be inserted.
- CGF membranes will be placed over the grafted area.
- Interrupted sutures will be performed. Radiographic evaluation of the bone density and tissue thickness will be performed by CBCT, immediate postoperative and after the procedure by 4 months. Clinical evaluation of the tissue thickness using periodontal probe immediate postoperatively and after the procedure by 4 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GTR with Autogenous Bone Chips and CGF Membrane | Other | Other: concentrated growth factor (CGF) Membrane |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- A medical history that contraindicates oral surgical treatment such as (uncontrolled/untreated diabetes mellitus, immuno-compromised status, radio or chemotherapy of the oral and maxillofacial region, treatment with oral and/or intravenous bisphosphonates).
- Presence of active or untreated periodontal disease.
- Vertical root fractures involving the buccal aspect.
- Tooth /teeth with horizontal fractures below bone level.
- Tooth /teeth with external or internal resorption.
Key exclusion criteria (0 listed)
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) MembraneThis is a third-generation autologous blood concentrate prepared using a dedicated centrifuge system. The process creates a fibrin-rich organic matrix from the patient's own blood, which is then molded into a membrane and packed over the grafted bone to enhance bone density increase and improvement of the surrounding tissue. | Other | GTR with Autogenous Bone Chips and CGF Membrane |
Primary outcome
tissue biotype
Time frame: preoperative, immediate postoperative and 4 months after the procedure
using periodontal probe to measure gingival thickness
2 secondary outcomes
bone density
Time frame: preoperative, immediately postoperative, and 4 months after the surgery
patient satisfaction
Time frame: after 4 months from the surgery
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 13 Apr 2026.
- Individual participant dataSharing planned: No
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Diagnostic Accuracy of Large Language Models for Peri-Implant Marginal Bone Loss on Panoramic Radiographs
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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.
meis youssef moustafa, bachelors contact
Hesham Elsayed Elhawary, Professor study chair
Cairo University
Abdelmoez Mohamed El-Sharkawy, Assistant Professor study director
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) Membrane in people with Alveolar Bone Loss and Alveolar Ridge Augmentation, 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 12 inclusion and 0 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 13 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 meis youssef moustafa, bachelors (00201065186643 ext. 00201065186643, meis.eltanany@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
tissue biotype (time frame: preoperative, immediate postoperative and 4 months after the procedure). 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 13 Apr 2026.