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.

ConditionsAlveolar Ridge Resorption Bone Loss in the Esthetic Zone Socket Shield Technique Partial Extraction Therapy Immediate Dental Implant Placement Bone Regeneration Using Concentrated Growth Factor Alloplastic Bone Grafting

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorCairo University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participants must be 18 years of age or older.

Both male and female patients.

Maxillary, anterior and premolar segments.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

Socket Shield Technique with CGF and Alloplastic Graft.
Procedure/Surgery
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

Treatment groups

7 Participants

are divided into 1 treatment group

Group A: Socket Shield Technique with CGF and Alloplastic GraftExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Change in Crestal Bone Level

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.

Time frame

From 2 weeks post-operatively to 6 months post-operatively.

Secondary outcomes

Primary Implant Stability

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.

Time frame

From the time of implant placement (Day 0) to 6 months post-operatively.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cairo University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: