Evaluation of a Lateral Window Technique Augmentation for Maxillary Sinus Using Ultrasound Activated Pins
NCT ID: NCT02449707
Last Updated: 2015-05-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
20 participants
INTERVENTIONAL
2015-04-30
2016-08-31
Brief Summary
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Detailed Description
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Patient selection:
20 patients requiring bilateral maxillary sinus lift procedure (40 procedures) will be selected from the patients reporting for implant placement to both the Riyadh Colleges of Dentistry and Pharmacy and the Riyadh Dental Center, King Saud Medical City.
Graft Placement:
Each patient will receive both the pin stabilized and the conventional graft placement procedures with standardized allografts (Purus® Cancellous Allograft?) on both sides of the maxilla. The grafts will be placed using the lateral window technique. The patients will be randomly assigned into either those who receive the pin first (Group A) or those who receive the conventional technique (using collagen membranes) first (Group B). The patients will have a one week gap between the sinus lift on the right and left sides.
Evaluations of the sinus lift procedure:
The sinus lift will be evaluated clinically radiographically and histologically using previously established criteria. Cone Beam CTs (Gallelios Comfort plus, Sirona Dental, Salzburg, Austria) will be taken preoperatively and at three month intervals to help assess the osseous outcomes of the graft.
At the end of one year the site will be evaluated clinically for the placement of implants. At the time of placement of the implant a trephine biopsy will be performed and H\&E staining will be used to determine the histological outcomes of the graft procedure.
Statistical Analysis:
The paired t test will be used to compare the thickness of bone before and after the completion of the sinus lift procedure. The multiple measures paired ANOVA will be used to compare the thickness of bone at each follow up vist.
The student's t test will be used to compare the thickness of bone between the two types of sinus lift procedure.
The chi-square test will be used to compare differences (if any) in the histological patterns obtained at the end of the study.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Control
Lateral Window Technique Augmentation for Maxillary Sinus without the use of Ultrasound activated resorbable poly-D-L-lactide pins for the stabilization of membrane. Placement of Purus® Cancellous Allograft, stabilized by Biomend ™ Collagen membrane. Cone Beam CT image of the sinus will be taken to evaluate the bone formation. Trephine Biopsy will be performed after 1 year, at the time of placement of implant to check the quality of bone formed.
Lateral Window Technique Augmentation for Maxillary Sinus
Maxillary sinus augmentation will be performed using the lateral window technique
Purus® Cancellous Allograft
Allograft material placed in the sinus to acheive sinus augmentation
Biomend
Collagen healing membrane placed over the graft material on the side where no ultrasound activated pins are being used
Cone Beam CT image of the Sinus
Cone beam CT will used to assess the thickness of bone formation after the placement of the graft
Trephine Biopsy
Trephine Biopsy will be performed at the time of the placement of implant to study the quality of bone formed
Ultrasonic Pins
Lateral Window Technique Augmentation for Maxillary Sinus with the use of Ultrasound activated resorbable poly-D-L-lactide pins for the stabilization of the Purus® Cancellous Allograft, and Resorb X Membrane.Cone Beam CT image of the sinus will be taken to evaluate the bone formation. Trephine Biopsy will be performed after 1 year, at the time of placement of implant to check the quality of bone formed.
Lateral Window Technique Augmentation for Maxillary Sinus
Maxillary sinus augmentation will be performed using the lateral window technique
Ultrasound activated resorbable poly-D-L-lactide pins
The titanium membrane placed during the maxillary sinus augmentation procedure will be stabilized using ultrasound activated resorbable poly-D-L-lactide pins
Purus® Cancellous Allograft
Allograft material placed in the sinus to acheive sinus augmentation
Resorb X Membrane
The membrane placed over the graft material before placement of the ultrasound activated pins
Cone Beam CT image of the Sinus
Cone beam CT will used to assess the thickness of bone formation after the placement of the graft
Trephine Biopsy
Trephine Biopsy will be performed at the time of the placement of implant to study the quality of bone formed
Interventions
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Lateral Window Technique Augmentation for Maxillary Sinus
Maxillary sinus augmentation will be performed using the lateral window technique
Ultrasound activated resorbable poly-D-L-lactide pins
The titanium membrane placed during the maxillary sinus augmentation procedure will be stabilized using ultrasound activated resorbable poly-D-L-lactide pins
Purus® Cancellous Allograft
Allograft material placed in the sinus to acheive sinus augmentation
Resorb X Membrane
The membrane placed over the graft material before placement of the ultrasound activated pins
Biomend
Collagen healing membrane placed over the graft material on the side where no ultrasound activated pins are being used
Cone Beam CT image of the Sinus
Cone beam CT will used to assess the thickness of bone formation after the placement of the graft
Trephine Biopsy
Trephine Biopsy will be performed at the time of the placement of implant to study the quality of bone formed
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Require Bilateral Maxillary Sinus Augmentation
* Consent to partipate in the study
Exclusion Criteria
* Uncontrolled Hypertensive patients with three consecutive diastolic readings of over 90mmHg
* History of Osteoporosis
45 Years
55 Years
ALL
Yes
Sponsors
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King Saud Medical City
OTHER_GOV
Riyadh Colleges of Dentistry and Pharmacy
OTHER
Responsible Party
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Dr Sharat Pani
Assistant Professor
Principal Investigators
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Bishi AlGarni, MSc
Role: STUDY_CHAIR
Riyadh Colleges of Dentistry and Pharmacy
Locations
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Riyadh Colleges of Dentistry and Pharmacy
Riyadh, , Saudi Arabia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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FRP/2014/109
Identifier Type: -
Identifier Source: org_study_id
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