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Active Not RecruitingNCT04581304

The Use of Bio-Oss Collagen for Sinus Augmentation Using the Transcrestal Approach.

Status
Active Not Recruiting
Phase
N/A
Study type
Interventional
Enrollment
36 (actual)
Sponsor
Rambam Health Care Campus · Academic / Other
Sex
All
Age
18 Years – 100 Years
Healthy volunteers
Accepted

Summary

To assess vertical bone height gain with Geistlich Bio-Oss Collagen used in conjunction with simultaneous implant installation in transcrestal approach sinus augmentation.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
DEVICEGeistlich Bio-Oss® CollagenGeistlich Bio-Oss® Collagen is intended to be used for filling bone defects and for bone augmentation.
DEVICEGeistlich Bio-Oss® GranulesGeistlich Bio-Oss® Granules is intended to be used for filling bone defects and for bone augmentation.

Timeline

Start date
2020-10-15
Primary completion
2026-12-17
Completion
2028-01-17
First posted
2020-10-09
Last updated
2025-11-19

Locations

1 site across 1 country: Israel

Source: ClinicalTrials.gov record NCT04581304. Inclusion in this directory is not an endorsement.