Efficacy of MimetikOss in Alveolar Ridge Preservation Previous to Implant Placement (NCT03374813) | Clinical Trial Compass
UnknownNot Applicable
Efficacy of MimetikOss in Alveolar Ridge Preservation Previous to Implant Placement
Chile, Spain102 participantsStarted 2017-11-16
Plain-language summary
The hypothesis tested in this clinical trial is that a biomimetic synthetic bone graft substitute (MimetikOss, Mimetis Biomaterials) with similar properties to those of human bone can reach a clinical outcome non inferior to that of a deproteinized bovine bone matrix bone graft substitute (Bio-Oss, Geistlisch) in an alveolar ridge preservation procedure followed by implant placement in terms of bone volume changes (primary end point), bone histological observation implant stability and bone level changes (secondary end points).
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:
* \>18 years old.
* Able to sign an informed consent form.
* Patients in need of socket preservation presenting 4 wall defects on premolar and molar zone in the maxilla or in the mandible.
* Healthy extraction site (no infected walls).
* The height of root molar bone support must be \> 6 mm. The height of root molar bone support plus the bone height between the most apical root part and the sinus floor must be \> 3 mm. As described in the picture below. Molar roots must be surgically separated previous to extraction
* Only 4 walled defects are included (3mm max of difference between buccal and lingual plate height).
* Presence of opposite occlusal dentition with natural roots in the area intended for extraction and implant placement.
* Natural roots are adjacent to implant site.
* If patient presents more than 1 defect that could be included in the study, only one will be part of the study, the other sites will be treated with the standard of care.
* Patient in good physical health.
* The subject is willing and able to comply with all study-related procedures (such as exercising oral hygiene and attending all follow-up procedures).
* Full-mouth bleeding score (FMBS) lower than 25%.
* The subject is suitable for a 2-stage surgical procedure.
Exclusion Criteria:
* Patients with premolar extraction due to the root fracture that present infected two wall type defect.
* Patients presenting the defect in the molar and/or premolar region of the maxilla with th…
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.