Prospective Neodent® Zirconia System Study (NCT04545840) | Clinical Trial Compass
UnknownNot Applicable
Prospective Neodent® Zirconia System Study
Brazil36 participantsStarted 2020-09-10
Plain-language summary
The Neodent® Zirconia Implant is designed for the treatment of oral endosteal implantation for the functional and aesthetic rehabilitation, allowing for treatment of patients with different bone qualities.
The objective of the study is to assess the success and survival rates of implantable devices of the Zirconia System, in order to confirm the long-term safety and clinical performance of implants and abutments of the Zirconia System in daily dental practice setting.
Devices will be used according to standard routine in daily practice, according to manufacturer indications in the IFU. Patients will be followed for 36 months after implant placement.
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 of age or older;
* Maxillary posterior teeth missing, with adjacent natural teeth;
* Patient who are in need of oral rehabilitation with dental implants and single prostheses and qualify for placement of Zirconia Implants.
Exclusion Criteria:
Subjects under 18 years of age, pregnant or breastfeeding women. And patients that present the device contraindications according to the IFU (instructions for use):
* Signs of allergy or hypersensitivity to the chemical ingredients of the material: Zirconia (Y-ZTP), Zirconium dioxide (ZrO2), Yttrium oxide (Y2O3), Hafnium dioxide (HfO2), Aluminum oxide (Al2O3);
* Acute inflammatory or infectious processes;
* Unsuitable bone volume or quality;
* Serious medical problems (e.g. bone metabolism disorders, blood clotting disorders, unsuitable healing capacity);
* Incomplete jawbone growth;
* Patient uncooperative and not motivated;
* Hypochondria;
* Alcoholism;
* Psychosis;
* Prolonged functional disorders which resist any treatment with medications;
* Xerostomia;
* Weakened immunological system;
* Diseases which require regular use of steroids;
* Uncontrolled endocrine diseases;
* Insufficient oral hygiene;
* Pregnancy;
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.