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Not Yet RecruitingNCT07521514

Evaluation of Guided Tissue Regeneration With Autogenous Bone Chips and CGF During Implant Placement

Clinical and Radiographic Evaluation of Guided Tissue Regeneration Using Autogenous Bone Chips and Concentrated Growth Factors Membranes With Simultaneous Implant Placement. (Case Series)

Status
Not Yet Recruiting
Phase
N/A
Study type
Interventional
Enrollment
8 (estimated)
Sponsor
Cairo University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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. 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.

Conditions

Interventions

TypeNameDescription
OTHERconcentrated 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.

Timeline

Start date
2026-04-16
Primary completion
2026-09-01
Completion
2026-10-01
First posted
2026-04-13
Last updated
2026-04-13

Locations

1 site across 1 country: Egypt

Source: ClinicalTrials.gov record NCT07521514. Inclusion in this directory is not an endorsement.

Evaluation of Guided Tissue Regeneration With Autogenous Bone Chips and CGF During Implant Placement (NCT07521514) · Clinical Trials Directory