Interventional Recruiting
NCT05584566 on ClinicalTrials.gov
Ridge Augmentation Treatment Using OSSIX® BREEZE vs Jason®
Official title: Ridge Augmentation Treatment Using OSSIX® BREEZE vs Jason® Membrane in Simultaneous Implantations. A Prospective, Randomized Controlled Trial.
- Sponsor: KaVo Dental (Germany)
- Enrollment: 65 (Estimated)
- Study start: 2022-12-01 (Actual)
- Primary completion: 2026-06-01 (Estimated)
- Study completion: 2026-07-01 (Estimated)
- Allocation: Randomized
- InterventionModel: Parallel
- Masking: Single (Participant)
- PrimaryPurpose: Treatment
Brief Summary
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®).
Conditions
- Ridge Augmentation
Intervention / Treatment
- Device: OSSIX Breeze
- Device: Jason membrane
Primary Outcome Measures
-
increase in bone gain
(4 months)
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
Countries
Israel, United Kingdom
Locations and Investigators
-
Hadassah Medical Center, Jerusalem, Israel (Recruiting)
- Asaf Wilenski, Prof
-
Rabin Medical Center, Petah Tikva, Israel (Recruiting)
- Gabi Chaushu, prof
-
University of Birmingham, Birmingham, United Kingdom (Recruiting)
- Thomas Dietrich, Prof