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NCT Number: NCT07514871

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.

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry

Cairo, Cairo Governorate, 12613, Egypt

Location contact

Ibrahim Ahmad Anas Jadoo

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Socket Shield Technique with CGF and Alloplastic Graft.

Procedure

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ibrahim Ahmad Anas Jadoo

CONTACT

[email protected]

+201094027357

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Acronym: CGF

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 7, 2026
Registry last updated
Apr 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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