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

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)

Overview

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.

Interventions

• Other concentrated growth factor (CGF) Membrane
  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.

Primary outcome measures

• tissue biotype [Time frame: preoperative, immediate postoperative and 4 months after the procedure]

Secondary outcome measures (2)

• bone density [Time frame: preoperative, immediately postoperative, and 4 months after the surgery]
• patient satisfaction [Time frame: after 4 months from the surgery]

Eligibility criteria

Inclusion 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).

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Egypt · 1 center

• Cairo University — Giza

Identifiers

NCT: NCT07521514 · omfs3-3-20

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗