Retrospective Data Collection Evaluating the Performance of a Novel Biomimetic Synthetic Bone Substitute (Creos® Syntogain) up to 72 Months Follow-up
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 173
- Locations
- 2
- Primary Endpoint
- Implant survival
Study Overview
Brief Summary
Guided bone regeneration (GBR) is a commonly performed technique, using autogenous grafts, allografts, xenografts, or synthetic bone grafts (SBG). Advantages of an "off the shelf" substitute, available anytime with limitless fabrication capacity that avoids human, or animal associated morbidity provides SBG with a very positive future perspective. This data collection is to retrospectively evaluate the long-term clinical performance of a CE marked biomimetic SBG substitute in patients with implant placement related bone regeneration treatments up to 72 months of follow-up. The study hypothesis states that a biomimetic SBG is a verified graft choice to be used clinically in patients with implant placement related bone regeneration treatments such as socket preservation with a delayed implant placement, GBR simultaneous with immediate implant placement, and sinus lift elevation with lateral approach.
Detailed Description
- Title
Retrospective data collection evaluating the performance of a novel biomimetic synthetic bone substitute (Creos® Syntogain) up to 72 months follow-up. 2. Introduction
Edentulism, partial or full, can be predictably treated with esthetic and functional results with implant supported prosthesis when adequate alveolar bone is present. Jawbone defects or post-extraction edentulism atrophy of the alveolar bone need appropriate surgical techniques to preserve or augment the alveolar process. Guided bone regeneration (GBR) is a commonly performed technique, using autogenous grafts, allografts, xenografts, or synthetic bone grafts (SBG). Advantages of an "off the shelf" substitute, available anytime with limitless fabrication capacity that avoids human, or animal associated morbidity provides SBG with a very positive future perspective. However, successful clinical performance and results with the use SBG must be supported by scientific clinical evidence. This data collection is to retrospectively evaluate the long-term clinical performance of a CE marked biomimetic SBG substitute in patients with implant placement related bone regeneration treatments up to 72 months of follow-up. 3. Study hypothesis, aims and objectives
The study hypothesis states that a biomimetic SBG is a verified graft choice to be used clinically in patients with implant placement related bone regeneration treatments such as socket preservation (SP) with a delayed implant placement (DIP), GBR simultaneous with immediate implant placement (IIP), and sinus lift elevation with lateral approach (SLE).
In order to test this hypothesis, the primary objective of this study is to retrospectively evaluate the clinical performance of a CE marked biomimetic SBG substitute (Creos® Syntogain, Nobel Biocare, Switzelrand) in patients with implant placement related bone regeneration treatments.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •The subject was at least 18 years of age (or age of consent) and has finalized skeletal growth at the time of surgery.
- •Patient was in need of one or multiple tooth replacements.
- •Treatment using synthetic bone graft was done for implant placement either in IIP or DIP.
Exclusion Criteria
- •Previous bone augmentation procedures with a different treatment choice (lateral or vertical regeneration).
Outcomes
Primary Outcomes
Implant survival
Time Frame: From final prosthesis delivery through study completion, up to 72 months.
Implant in place at any follow up visit
Prosthesis survival
Time Frame: From final prosthesis delivery through study completion, up to 72 months.
Prosthesis survival at any follow up visit
Secondary Outcomes
- Peri-implant evaluation, soft tissue evaluation PES-WES score(From final prosthesis delivery through study completion, up to 72 months.)
- Peri-implant evaluation, marginal bone loss(From final prosthesis delivery through study completion, up to 72 months.)
- Complications(From initial surgical procedure date (GBR or implant placement) through study completion, up to 72 months)
