To assess vertical bone height gain with Geistlich Bio-Oss Collagen used in conjunction with simultaneous implant installation in transcrestal approach sinus augmentation.
One of the most common situations in the posterior maxilla is reduced alveolar bone height as a result of tooth extraction and the following bone remodeling process, and maxillary sinus pneumatization. Lack of alveolar bone volume may compromise dental implant installation. Maxillary sinus augmentation is considered a very predictable solution for implant installation in limited amount of bone in the posterior maxilla. In general, there are two main maxillary sinus augmentation methods: the lateral approach and the transcrestal. In both methods, the idea is to expend the alveolar ridge in vertical direction on the expense of the maxillary sinus. Sinus augmentation using the transcrestal approach is a well known procedure which is being use for over 40 years. As time goes by, implant dentistry is evolving and improving, there is a constant progress in this field including new bone substitutes materials. Geistlich Bio-Oss® Collagen - can improve the results obtained by sinus augmentation using the transcrestal approach, by better ease of use for the operator which makes it easier for the operator and the patient. Study hypothesis: The vertical bone height gained by using Geistlich Bio-Oss Collagen in transcrestal approach sinus augmentation will be comparable to using Bio-Oss Collagen, with greater operator satisfaction and less intra-operative complications.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
36
Geistlich Bio-Oss® Collagen is intended to be used for filling bone defects and for bone augmentation.
Geistlich Bio-Oss® Granules is intended to be used for filling bone defects and for bone augmentation.
Rambam Health Care Campus, Dept. of Periodontology
Haifa, Israel
Vertical bone height. (mm)Changes in augmented bone after transcrestal approach sinus augmentation.
Measuring the changes in augmented bone volume after transcrestal approach sinus augmentation.
Time frame: Pre op; immediately post-op, at 6 months and 3 years from second stage surgery.
Procedure time measurement. (min)
To evaluate the time needed for transcrestal approach sinus augmentation using Bio-Oss collagen® and in the conventional way, using Bio-Oss granules.
Time frame: The procedure time measurement will start after flaps are elevated at pilot drilling (2.4mm diameter). and it will be stopped when the implant was inserted and insertion torque was assessed.
Patients and operator satisfaction. (1-10 ruler scale)
To study operator and patients satisfaction using the 2 materials. They will be assessed by giving the patients questionnaires and satisfaction ruler using a 1-10 ruler scale.
Time frame: At the suture removal visit - 14 days after procedure.
Complications
Explore intra and post operative complications.
Time frame: During the procedure, During the follow up - 14 days, 6 months after intervention.
The success rate of osseointegrated implants. (%)
The percentage of osseointegrated implants that were installed with simultaneous transcrestal approach sinus augmentation.- using Bio-Oss collagen®.
Time frame: At 6 months and 3.5 years after intervention.
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