Retrospective Evaluation of a Novel Biomimetic Synthetic Bone Substitute (Creos® Syntogain) (NCT06473545) | Clinical Trial Compass
CompletedNot Applicable
Retrospective Evaluation of a Novel Biomimetic Synthetic Bone Substitute (Creos® Syntogain)
Spain173 participantsStarted 2023-04-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Implant survival
Timeframe: From final prosthesis delivery through study completion, up to 72 months.
2
Prosthesis survival
Timeframe: From final prosthesis delivery through study completion, up to 72 months.