Osseodensification Plus Platelet Rich Fibrin With Simultaneous Implant Installation in Closed Sinus Lift
April 9, 2023 updated by: hadeel bassam albahar, Arab American University (Palestine)
Osseodensification Plus Platelet Rich Fibrin With Simultaneous Implant Installation in Closed Sinus Lift : A Randomized Control Trial.
12 patients with indirect sinus lift will be selected with RBH>5mm , surgical procedure
=osseodensification + Prf+ implant .
- versah drilling system (osseodensefication technique )will be used , moreover Prf will be prepared by Blood collected in PRF tubes from patients then centrifuge (1300rpm ,14min ) .
- primary stability will be measured using Resonance Frequency Analysis by Osstellimmediately and after 6 Mn .
- CBCT will be taken before surgery , perioapical x-ray immediately after surgery and CBCT at 6m follow up to be apple to see the differences regarding bone quality and volume.
Study Overview
Study Type
Interventional
Enrollment (Actual)
12
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
-
-
-
Nablus, Palestinian Territory, occupied
- Hadeel Albahar
-
-
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 and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- medically fit non pregnant no sinus pathology
Exclusion Criteria:
- young patients under 18
- sinus pathology
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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Test group
Implant therapy and closed sinus lifting with A-PRF
|
prf+ osseodensification in close sinus lift
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
secondary stability of implant
Time Frame: 6 months
|
by osstel
|
6 months
|
|
bone density
Time Frame: 6 months
|
measuring and evaluating bone density by cbct
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: hadeel albahar, master, Arab American University
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 20, 2022
Primary Completion (Actual)
November 20, 2022
Study Completion (Actual)
December 30, 2022
Study Registration Dates
First Submitted
March 22, 2023
First Submitted That Met QC Criteria
March 22, 2023
First Posted (Actual)
April 4, 2023
Study Record Updates
Last Update Posted (Actual)
April 11, 2023
Last Update Submitted That Met QC Criteria
April 9, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- AAUP
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.