- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03684954
Effect Of PRF Versus Xenograft In Closed Sinus Lift.
September 25, 2018 updated by: Mahmoud adel shaaban
Prf Controlled, Randamized Clinical Trial of THE EFFECT OF PLATELET RICH FIBRIN( PRF ) VERSUS XENOGRAFT IN CLOSED SINUS LIFT AND IMLANT PLACEMENT ON IMPLANT STABILITY IN PATIENTS WITH MISSING MAXILLARY PREMOLAR.
Indirect sinus lift with used PRF as a graft material versus xenograft
Study Overview
Detailed Description
Crestal incision and reflect the tissue until exposure of the bone, then use drilling to make osteotomy.
Then use sutable osteotomes to elevate the sinus floor, then pack of Prf or bone graft in the osteotomy and implant placement .
Then closed the flap and suturing.
Study Type
Interventional
Enrollment (Anticipated)
10
Phase
- Not Applicable
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
25 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Edentulous area and bone high at least 5-6 mm below the maxillary sinus at maxillary premolar.
- Good oral hygiene.
Exclusion Criteria:
- bad oral hygiene.
- patient with systemic disease that may affect normal healing
- pregnant patients.
- patients with bone diseases and presence of periapical pathology affecting the neighboring teeth.
- Heavy smoker more than 20 cigarettes per day
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 |
---|---|
Other: Used of PRF in clsed sinus lifting
Used of PRF in closed sinus lifting with implant placement
|
Take 10 cc blood from patient and gain prf
|
No Intervention: Closed sinus with xenograft
used of xenograft in closed sinus lift with implant placement.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Primary stability by ostell device
Time Frame: up to 3 months
|
Implant stability will be mesured by ostell device, implant stability will be mesured intra operative at 0 ( time of implant placement ) and 2, 4, 6, 10 and 12 weeks after surgery
|
up to 3 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 (Anticipated)
October 1, 2018
Primary Completion (Anticipated)
August 30, 2019
Study Completion (Anticipated)
August 30, 2019
Study Registration Dates
First Submitted
September 16, 2018
First Submitted That Met QC Criteria
September 25, 2018
First Posted (Actual)
September 26, 2018
Study Record Updates
Last Update Posted (Actual)
September 26, 2018
Last Update Submitted That Met QC Criteria
September 25, 2018
Last Verified
September 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- Cairo Univ.
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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