A Clinical Study on Acuris™ - Conometric Concept for Single Tooth Restoration (NCT04063878) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
A Clinical Study on Acuris™ - Conometric Concept for Single Tooth Restoration
United States, Canada, Germany160 participantsStarted 2019-07-30
Plain-language summary
The purpose of this study is to evaluate the outcome of prosthetic survival of the Acuris conometric concept 1 year after permanent restoration, since this is a new mode of retention using friction for seating the crown of single tooth restorations without using cement or screws.
Who can participate
Age range
18 Years – 75 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
. Subject aged between 18-75 years
. Subject signed and dated the informed consent form
. In need of an implant replacing a missing tooth in position 17 to 27 or 37 to 47, and each subject can only receive one study implant.
. Neighbouring tooth to the planned implant must have
. Presence of natural tooth, partial prosthesis and/or implant supported restoration in the opposite jaw in contact with the planned crown
. Deemed by the investigator as likely to present an initially stable implant situation
Exclusion criteria
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.
. Unlikely to be able to comply with study procedures, according to Investigators judgement
. Subject is not willing to participate in the study or not able to understand the content of the study
. Involvement in the planning and conduct of the study
. Severe non-compliance to CIP as judged by the Investigator and/or Dentsply Sirona Implants.
. Unable or unwilling to return for follow-up visits for a period of five years
. Simultaneous participation in another clinical study, or former participation in a clinical study during the last 6 months that may interfere with the present study
. Previous enrolment in the present study
. Uncontrolled pathological process in the oral cavity