- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07534787
Clinical and Radiographic Evaluation of Ridge Splitting With Simultaneous Implant Placement Covered With Concentrated Growth Factor Membranes in Narrow Alveolar Ridge (CGF)
Clinical and Radiographic Evaluation of Ridge Splitting With Simultaneous Implant Placement Covered With Concentrated Growth Factor Membranes in Narrow Alveolar Ridge (Case Series).
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study is a case series conducted at the outpatient clinic of the Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Cairo University. It aims to evaluate the tissue biotype and bone density around dental implants in adult patients with narrow alveolar ridge.
Alveolar ridge resorption and soft tissue shrinkage after tooth extraction represent a major problem affecting both aesthetics and function. Therefore, preserving alveolar bone and improving soft tissue conditions are essential for successful implant placement. The use of concentrated growth factor (CGF) membranes combined with ridge splitting and simultaneous implant placement may enhance healing, reduce postoperative pain, and improve tissue biotype and bone density.
All patients will undergo clinical and radiographic assessment before the procedure. Preoperative CBCT will be used for surgical planning. Tissue thickness will be measured using a periodontal probe. During surgery, ridge splitting will be performed followed by implant placement, and CGF membranes will be applied over the grafted area. Autologous bone chips will be used for augmentation.
Postoperative evaluation will include assessment of tissue biotype, bone density using CBCT, and pain using visual analogue scale (VAS). Follow-up will be carried out immediately after surgery and up to 4 months postoperatively.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Tasneem Farrag Ayoub, Master
- Phone Number: +201146245469 +201125888649
- Email: tasneem.farrag@dentistry.cu.edu.eg
Study Locations
-
-
-
Cairo, Egypt
- Cairo University
-
Contact:
- Tasneem Farrag Ayoub, Master
- Phone Number: +201125888659
- Email: tasneem.farrag@dentistry.cu.edu.eg
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Cairo, Egypt
- Faculty of Dentistry, Cairo University
-
Contact:
- Tasneem Farrag Badran, Master
- Phone Number: 01146245469
- Email: tasneem.farrag@dentistry.cu.edu.eg
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
-
Patients with narrow alveolar ridge indicated for implant placement Age between 20 and 50 years Good general health Patients with adequate oral hygiene
Exclusion Criteria:
- Patients with systemic diseases affecting bone healing Smokers Pregnant or lactating females Patients with poor oral hygiene Patients with history of radiation therapy in the head and neck region
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: Ridge Splitting with Simultaneous Implant Placement and CGF
Patients with narrow alveolar ridge will undergo ridge splitting with simultaneous implant placement.
Concentrated growth factor (CGF) membranes will be prepared from the patient's blood and placed over the grafted area.
Autologous bone chips will be used for augmentation.
Clinical and radiographic evaluation will be performed to assess tissue biotype, bone density, and pain during follow-up period.
|
Patients with narrow alveolar ridge will undergo ridge splitting procedure using chisel to allow implant placement.
Intervention Description: Dental implants will be inserted simultaneously after ridge splitting in the prepared alveolar ridge.
CGF membranes will be prepared from patient venous blood and placed over the grafted area to enhance healing and tissue regeneration.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain (VAS score)
Time Frame: 1st day and 3rd day postoperative
|
Pain will be assessed using Visual Analogue Scale (VAS) ranging from 0 to 10.
|
1st day and 3rd day postoperative
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Tissue biotype thickness
Time Frame: Immediately postoperative and after 4 months
|
Tissue biotype will be assessed using a periodontal probe and measured in millimeters.
|
Immediately postoperative and after 4 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Bone density
Time Frame: Immediately postoperative and after 4 months
|
Bone density will be evaluated using CBCT and measured in Hounsfield units (HU).
|
Immediately postoperative and after 4 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Abdelmoez Mohamed El-Sharkawy, Associate Professor, Cairo University
- Study Chair: Hesham Said Said, Professor, 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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Omfs 3-3-18.
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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