Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a prospective randomized controlled parallel trial. The aim of this study is to evaluate bone formation and soft tissue healing after 4 and 8 months in patients with ridge deficiencies in simultaneous implantation approach. The trial will compare a (sugar cross linked) - SCL pericardium membrane OSSIX® Breeze vs native pericardium membrane (Jason®).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OSSIX Breeze | Experimental |
| |
| Jason membrane | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OSSIX Breeze | Device | barrier membrane |
| |
| Jason membrane |
| Measure | Description | Time Frame |
|---|---|---|
| increase in bone gain | increase in bone gain (vertical and horizontal) in mm, 4 months after the implant placement in the augmented site. the measurment will be done according to radiographic images | 4 months |
Not provided
Not provided
Inclusion Criteria:
10 8. Patient is able to understand and comply with the study related procedures, such as exercising good oral hygiene and attending all follow-up examinations.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gavriel Chaushu, prof | Contact | +97239377207 | GavrielCe@clalit.org.il |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hadassah Medical Center | Recruiting | Jerusalem | Israel |
Not provided
Not provided
Not provided
Not provided
Not provided
| Device |
barrier membrane |
|
| Rabin Medical Center | Recruiting | Petah Tikva | 4928451 | Israel |
|
| University of Birmingham | Recruiting | Birmingham | United Kingdom |
|