- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07520513
Socket Shield Technique With CGF and Xenograft for Immediate Implants (CGF)
Clinical and Radiographic Evaluation of Bone Grafting Using Concentrated Growth Factors and Xenograft With Simultaneous Immediate Implant Placement in Socket Shield Technique
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study is designed as a prospective case series to evaluate the effectiveness of combining concentrated growth factors (CGF) and xenograft with the socket shield technique (SST) during immediate implant placement in the maxillary esthetic region.
Post-extraction alveolar ridge resorption, particularly of the buccal bone plate, represents a significant challenge in achieving optimal esthetic outcomes. The socket shield technique has been introduced to preserve the buccal bone by retaining the labial portion of the root, thereby minimizing post-extraction resorption. However, immediate implant placement is often associated with the presence of a gap between the implant surface and the socket wall, known as the "jumping gap," which may compromise implant stability and osseointegration.
To enhance bone regeneration within this gap, bone grafting materials are commonly utilized. Concentrated growth factors (CGF), an autologous platelet concentrate, have demonstrated the ability to promote angiogenesis, osteogenesis, and soft tissue healing through the sustained release of growth factors. When combined with xenograft, which provides an osteoconductive scaffold, this approach may improve bone regeneration and implant integration.
In this study, eligible patients requiring immediate implant placement in the esthetic zone will undergo partial extraction therapy using the socket shield technique. Implants will be placed immediately after extraction, and CGF will be prepared from the patient's venous blood and mixed with xenograft to form a "sticky bone" graft, which will be applied to fill the jumping gap.
Radiographic evaluation will be performed using cone-beam computed tomography (CBCT) at 2 weeks and 6 months postoperatively to assess crestal bone level changes. Implant stability will be measured using resonance frequency analysis (Osstell device) and expressed as implant stability quotient (ISQ) values.
The findings of this study are expected to provide clinical and radiographic evidence regarding the effectiveness of combining CGF and xenograft with the socket shield technique in enhancing bone regeneration and improving outcomes of immediate implant placement in the esthetic zone.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Huda Ayman Alrifai, bachelors
- Phone Number: +201111373439 +201111373439
- Email: hoda.elrefai@dentistry.cu.edu.eg
Study Locations
-
-
Cairo Governorate
-
Cairo, Cairo Governorate, Egypt, 11553
- Faculty of Dentistry, Cairo University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion criteria:
- Age ≥18 years old. (Younis, W., & El-Rashidy, A. 2020).
- Both male and female patients.
- Maxillary, anterior and premolar segments.
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.
Study Plan
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 Xenograft in Immediate Implant Placement
Participants will undergo immediate implant placement in the esthetic zone using the socket shield technique.
Following partial extraction therapy, implants will be placed immediately, and the jumping gap will be filled using a combination of concentrated growth factors (CGF) and xenograft prepared as "sticky bone."
Clinical and radiographic follow-up will be conducted over a 6-month period to evaluate crestal bone levels and implant stability.
|
The procedure involves partial extraction therapy using the socket shield technique, where the buccal portion of the root is preserved to maintain the alveolar bone.
Immediate implant placement is performed into the extraction socket.
Concentrated growth factors (CGF) are prepared from the patient's autologous blood via centrifugation and combined with xenograft to form a "sticky bone" graft.
This graft is placed in the jumping gap between the implant and socket wall to enhance bone regeneration and healing.
Implant stability will be measured using resonance frequency analysis (Osstell), and radiographic evaluation will be performed using CBCT.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
crestal bone level
Time Frame: 2 weeks, and 6 months postoperatively
|
Evaluation of changes in crestal bone level around the dental implant using cone-beam computed tomography (CBCT).
Measurements will be taken from a fixed reference point on the implant to the first bone-to-implant contact recorded in millimeters (mm)
|
2 weeks, and 6 months postoperatively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Implant Stability (ISQ Values)
Time Frame: Immediate postoperative, and at 6 months
|
Implant stability will be assessed using resonance frequency analysis with the Osstell device and recorded as Implant Stability Quotient (ISQ).
ISQ values range from 1 to 100, where higher values indicate greater implant stability and a better outcome.
|
Immediate postoperative, and at 6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Abdelmoez Mohamed El-Sharkawy, Associate Professor, Cairo University
- Study Chair: Tarek I.A El-Ghareeb, PHD Holder, Cairo University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Bone Diseases
- Musculoskeletal Diseases
- Periodontal Atrophy
- Periodontal Diseases
- Mouth Diseases
- Stomatognathic Diseases
- Alveolar Bone Loss
- Bone Resorption
- Surgical Procedures, Operative
- Transplantation
- Prosthesis Implantation
- Dentistry
- Oral Surgical Procedures
- Prosthodontics
- Dental Implantation, Endosseous
- Dental Implantation
- Oral Surgical Procedures, Preprosthetic
- Transplantation, Heterologous
- Immediate Dental Implant Loading
Other Study ID Numbers
- OMFS-3-3-20
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.