Clinical and Radiographic Evaluation of CGF and Alloplastic Grafting in Participants Undergoing the Socket Shield Technique for Immediate Anterior Maxillary Implant Placement. This Study Assesses Bone Healing and Stability When Managing the Crestal Gap in the Esthetic Zone. (CGF)

March 31, 2026 updated by: IBRAHIM AHMAD ANAS JADOO, Cairo University

Clinical and Radiographic Evaluation of Bone Grafting Using CGF and Alloplastic Graft With Simultaneous Immediate Implant Placement in Socket Shield Technique (Case Series Study).

The goal of this clinical trial is to evaluate the clinical and radiographic effectiveness of the socket shield technique combined with concentrated growth factor (CGF) and alloplastic graft in promoting bone healing and achieving successful immediate implant placement in the esthetic zone.

This prospective case series involves both male and female participants aged 18 years or older who require immediate implant placement in the maxillary anterior segments. The main questions it aims to answer are :

Does the combined use of CGF and alloplastic grafting materials with the socket shield technique improve crestal bone levels as measured by CBCT?

How does this intervention affect secondary outcomes such as primary implant stability measured via the Osstell implant stability quotient?

Participants will: Undergo a socket shield procedure (partial extraction therapy) where the labial root fragment is retained to preserve the buccal bone. Provide a blood sample for the preparation of autologous CGF. Receive simultaneous immediate implant placement. Have a "sticky bone" mixture of CGF and alloplastic graft packed into the jumping gap around the implant. Attend follow-up appointments for clinical assessments and CBCT imaging at 2 weeks and 6 months post-operatively.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This prospective case series investigates the synergistic effect of Concentrated Growth Factor (CGF) and alloplastic bone substitutes within the Socket Shield Technique. The primary clinical challenge addressed is the "jumping distance" or crestal gap that naturally forms between an implant and the extraction socket wall. While SST is designed to prevent the resorption of the buccal bundle bone by retaining a root fragment, this study explores whether the biological enhancement of CGF can further optimize the regenerative environment .Technical Procedure and Biological Rationale The surgical protocol utilizes a Partial Extraction Therapy approach where the tooth crown is decapitated and the root is sectioned mesiodistally. A labial shield is maintained to provide structural support to the labial bone plate. Following a standard osteotomy, the "sticky bone" complex is prepared .The Concentrated Growth Factor (CGF) is produced using a specialized centrifuge with a variable spin-speed protocol, which results in a denser fibrin network compared to first or second-generation platelet concentrates. This matrix allows for the sustained release of essential signaling molecules to promote osteogenesis and soft tissue regeneration. Regenerative Synergy The intervention combines the biological activity of the autologous CGF with the osteoconductive properties of an alloplastic graft. While the alloplastic material provides a stable, predictable scaffold to maintain space and volume within the jumping gap, the CGF accelerates the early stages of healing and bone formation. This combination is hypothesized to provide superior mechanical and biological properties for long-term stability in the esthetic zone .Clinical Monitoring Following immediate temporization, participants enter a strict plaque control regimen. Longitudinal evaluation is performed using limited-field Cone-Beam Computed Tomography (CBCT) to quantify changes in bone volume and integration. These scans are conducted at specific intervals to monitor the transition from early healing to the final bone remodeling phase prior to definitive prosthetic loading.

Study Type

Interventional

Enrollment (Estimated)

7

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
    • Cairo Governorate
      • Cairo, Cairo Governorate, Egypt, 12613
        • Faculty of Dentistry
        • Principal Investigator:
          • Ibrahim Ahmad Anas Jadoo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Participants must be 18 years of age or older.
  • Both male and female patients.
  • Maxillary, anterior and premolar segments.

Exclusion Criteria:

  • A medical history that contraindicates oral surgical treatment (uncontrolled/untreated diabetes mellitus, immuno-compromised status, radio/chemotherapy of the oral and maxillofacial region, treatment with oral and/or intravenous amino-bisphosponates).
  • Untreated periodontal disease.
  • Vertical root fractures on the buccal aspect.
  • Tooth /teeth with horizontal fractures below bone level.
  • Tooth /teeth with external or internal resorptions.
  • Patients with any oral destructive habits such as smoking, chewing tobacco, bruxism, etcetera.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Socket Shield Technique with CGF and Alloplastic Graft
In this single-group prospective case series, participants undergo the Socket Shield Technique (partial extraction therapy) for simultaneous immediate implant placement in the maxillary anterior segments. The surgical intervention involves decapitating the tooth crown and sectioning the root mesiodistally to retain a labial segment that is remains firmly attached to the buccal bone. After the implant is inserted into the prepared site, a "sticky bone" complex is prepared by centrifuging a 10 mL sample of the patient's blood to extract autologous Concentrated Growth Factor (CGF). This CGF fibrin matrix is combined with an alloplastic bone graft and carefully packed into the "jumping gap" between the implant periphery and the surrounding bone to facilitate enhanced bone regeneration and healing. Follow-up includes immediate temporization and longitudinal monitoring of crestal bone levels and implant stability via CBCT and Osstell.
Procedure: Socket Shield Technique with CGF and Alloplastic Graft.
The intervention consists of a specialized surgical and regenerative protocol that combines the Socket Shield Technique with the application of a "sticky bone" complex for simultaneous immediate implant placement. Unlike conventional extraction, this partial extraction therapy involves decapitating the tooth crown and sectioning the root mesiodistally to retain a labial segment, which is remains firmly attached to the buccal bone to provide structural support. Following the immediate insertion of the dental implant, a third-generation platelet concentrate known as Concentrated Growth Factor (CGF) is prepared from the patient's blood using a variable spin-speed centrifuge to create a dense fibrin network rich in growth factors. This autologous CGF is then combined with a synthetic alloplastic bone graft to form the "sticky bone" mixture, which is carefully packed into the "jumping gap" between the implant periphery and the retained labial shield to facilitate enhanced bone regeneration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Crestal Bone Level
Time Frame: From 2 weeks post-operatively to 6 months post-operatively.
The primary outcome is the radiographic assessment of the Change in Crestal Bone Level, measured in millimeters using Limited-field Cone-Beam Computed Tomography (CBCT). This evaluation focuses on the vertical bone dimensions surrounding the dental implant.
From 2 weeks post-operatively to 6 months post-operatively.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary Implant Stability
Time Frame: From the time of implant placement (Day 0) to 6 months post-operatively.
This outcome measures the stability of the dental implant using Resonance Frequency Analysis via the Osstell device. The stability is quantified as an ISQ value on a scale of 1 to 100. Higher values indicate greater implant stability and better osseointegration. Measurements are taken to evaluate primary stability (at the time of implant placement) , providing a clinical assessment of how effectively the "sticky bone" (CGF and alloplastic graft) and the socket shield have supported the integration of the implant within the maxillary bone.
From the time of implant placement (Day 0) to 6 months post-operatively.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Study Director: Abdelmoez Mohamed El-Sharkawy, Associate Professor, Cairo University
  • Study Chair: Tarek El-Ghareeb, professor, Cairo University
  • Principal Investigator: Ibrahim Ahmad Anas Jadoo, Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 25, 2026

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

November 1, 2026

Study Registration Dates

First Submitted

March 31, 2026

First Submitted That Met QC Criteria

March 31, 2026

First Posted (Actual)

April 7, 2026

Study Record Updates

Last Update Posted (Actual)

April 7, 2026

Last Update Submitted That Met QC Criteria

March 31, 2026

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3-3-20

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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