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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Dental Implant; Alveolar Bone Loss; Alveolar Ridge Augmentation
• Intervention / Treatment: Other: concentrated growth factor (CGF) Membrane

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 Type: Interventional
• Enrollment (Estimated): 8
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: meis youssef moustafa, bachelors; Phone Number: 00201065186643 00201065186643; Email: meis.eltanany@dentistry.cu.edu.eg

Study Locations

• Egypt
  • Cairo Governorate
    • Giza, Cairo Governorate, Egypt, 12511
      • Cairo university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: GTR with Autogenous Bone Chips and CGF Membrane	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
tissue biotype	using periodontal probe to measure gingival thickness	preoperative, immediate postoperative and 4 months after the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
bone density	cbct xray	preoperative, immediately postoperative, and 4 months after the surgery
patient satisfaction	psq18 is a chart where the patient describes the level of their satisfaction	after 4 months from the surgery

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Chair: Hesham Elsayed Elhawary, Professor, Cairo university; Study Director: Abdelmoez Mohamed El-Sharkawy, Assistant Professor, Cairo university

Study record dates

Study Major Dates

• Study Start (Estimated): April 16, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: April 3, 2026
• First Submitted That Met QC Criteria: April 8, 2026
• First Posted (Actual): April 13, 2026

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 8, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: dental implant; CGF; guided tissue regeneration; gingival biotype; autogenous bone graft
• Additional Relevant MeSH Terms: Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Alveolar Bone Loss
• Other Study ID Numbers: omfs3-3-20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No