- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07678749
Closed Sinus Lifting Using Xenograft With or Without Liposomal Apigenin-Loaded Scaffold
Clinical and Radiographic Evaluation of Closed Sinus Lifting Using Xenograft With or Without Liposomal Apigenin-Loaded Scaffold : A Randomized Controlled Clinical Study
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Cairo, Egypt
- Alazhar university , cairo, egypt
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
1. Partially edentulous patients with a maxillary posterior edentulous ridge for more than 4 months after extraction.
2. Both males and females. 3. Adults aged between 18-50 years. 4. Systemically healthy individuals.
5. Residual alveolar ridge height ranging from 4 to 6 mm (measured by preoperative CBCT) 6. No previous surgical or radiation treatment involving the maxillary sinus.
Exclusion Criteria:
-
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Sham Comparator: control
closed sinus lifting using xenograft alone, followed by implant placement.
|
closed sinus lifting using xenograft + liposomal Apigenin-loaded scaffold, followed by implant placement.
|
|
Experimental: test group
closed sinus lifting using xenograft + liposomal Apigenin-loaded scaffold, followed by implant placement.
|
closed sinus lifting using xenograft + liposomal Apigenin-loaded scaffold, followed by implant placement.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
1. Bone height ( Apical Bone Height Gain ): Measured from first implant thread to sinus floor.
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
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
Other Study ID Numbers
- P-ME-25-11
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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