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.

Official 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).

Overview

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.

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.

Interventions

• 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 o

Primary outcome measures

• Change in Crestal Bone Level [Time frame: From 2 weeks post-operatively to 6 months post-operatively.]

Secondary outcome measures (1)

• Primary Implant Stability [Time frame: From the time of implant placement (Day 0) to 6 months post-operatively.]

Eligibility criteria

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.

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

• Faculty of Dentistry — Cairo

Identifiers

NCT: NCT07514871 · 3-3-20

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗