- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03184857
Open Maxillary Sinus Augmentation Using Different Types of Bone Particles
March 29, 2024 updated by: Mahmoud Ahmed Nour-El deen, Cairo University
Two Stage Sinus Lifting Using Nano Hydroxyapatite Particles [Nanostreams] Versus Deprotenized Bovine Bone [Tutogen] : Randomized Clinical Trial.
Two stage sinus lifting using Nano hydroxyapatite particles [Nanostreams] versus Deprotenized bovine bone [Tutogen] : Randomized clinical trial.
comparing between Height of new bone formation, Bone area percent( Histomorphometric)
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Cairo, Egypt, 11437
- Mahmoud Ahmed Nour Eldeen
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
-
Exclusion Criteria:
- sinus pathology
- heavy smokers
- patients with systemic disease uncontrolled
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: two stage sinus lifting using bovine bone particles
Open maxillary sinus lifting will be done with sinus augmentation using bovine bone particles
|
biopsy of the region 6 months later
|
|
Experimental: two sage sinus lifting using Nano HA bone particles
Open maxillary sinus lifting will be done with sinus augmentation using Nano HA bone particles
|
biopsy of the region 6 months later
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
histomorphometric analysis
Time Frame: 6 months
|
histomorphometric analysis to measure new bone percent formation and residual bone graft percent
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
new height of bone gained
Time Frame: 6 months
|
CBCT 6 months postoperative to measure the new height of bone
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2017
Primary Completion (Actual)
September 30, 2019
Study Completion (Actual)
September 30, 2019
Study Registration Dates
First Submitted
June 9, 2017
First Submitted That Met QC Criteria
June 9, 2017
First Posted (Actual)
June 14, 2017
Study Record Updates
Last Update Posted (Actual)
April 2, 2024
Last Update Submitted That Met QC Criteria
March 29, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- Cebc.cairouniversity - 1025
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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