- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07520526
Immediate Implant Placement Using Socket Shield With CGF (CGF)
Clinical and Radiographic Evaluation of Concentrated Growth Factors With Simultaneous Immediate Implant Placement in Socket Shield Technique
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This prospective case series study will be conducted to evaluate clinically and radiographically the effectiveness of the socket shield technique combined with concentrated growth factors (CGF) during immediate implant placement in the esthetic zone.
Eligible patients requiring extraction and immediate implant placement in the maxillary anterior or premolar region will be included. Following atraumatic extraction, partial extraction therapy using the socket shield technique will be performed, leaving the buccal root fragment in place. Implant osteotomy and placement will then be carried out according to manufacturer instructions.
Autologous concentrated growth factors will be prepared from the patient's blood using a CGF centrifugation protocol. The CGF gel will be packed into the jumping gap between the implant and socket wall to promote bone regeneration and healing.
Clinical and radiographic evaluation will be performed using CBCT at baseline, 2 weeks, and 6 months postoperatively. The primary outcome will be crestal bone level changes measured radiographically, while the secondary outcome will include implant stability assessed using Osstell measurements (ISQ values).
Seven participants will be recruited in this case series. Follow-up will be conducted to evaluate healing, bone remodeling, and implant stability.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Areej Khalid Rasheid, bachelors
- Phone Number: +201033903216 +201033903216
- Email: areej.rashyd@dentistry.cu.edu.eg
Study Locations
-
-
Cairo Governorate
-
Cairo, Cairo Governorate, Egypt, 11765
- 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 segment.
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
Immediate implant placement using socket shield technique combined with concentrated growth factors in the esthetic zone.
|
Partial extraction therapy using the socket shield technique followed by immediate implant placement.
Concentrated growth factors prepared from autologous blood will be packed in the jumping gap to enhance bone regeneration and healing.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Crestal bone level
Time Frame: 2 weeks and 6 months post-operatively
|
Radiographic evaluation of crestal bone level changes around the implant using CBCT, measured in millimeters (mm).
|
2 weeks and 6 months post-operatively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Implant stability
Time Frame: Immediately after implant placement 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.
|
Immediately after implant placement 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 Resorption
- Bone Diseases
- Musculoskeletal Diseases
- Periodontal Atrophy
- Periodontal Diseases
- Mouth Diseases
- Stomatognathic Diseases
- Alveolar Bone Loss
- Surgical Procedures, Operative
- Prosthesis Implantation
- Dentistry
- Oral Surgical Procedures
- Prosthodontics
- Dental Implantation, Endosseous
- Dental Implantation
- Oral Surgical Procedures, Preprosthetic
- 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.
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