A Clinical Study on Implants With TiUltra Technology and Associated Prosthetic Components (NCT04737421) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
A Clinical Study on Implants With TiUltra Technology and Associated Prosthetic Components
United States, Australia, Austria1,000 participantsStarted 2021-05-26
Plain-language summary
This is a multicenter, prospective, non-interventional study in which a total of 1000 subjects in need of a single, multiple or full arch restoration in any region of the mouth (healed or extracted) will be treated in up to 30 study centers. The primary aim of this study is to demonstrate non-inferiority of all NobelBiocare TiUltra implants to historic data from NobelActive TiUnite coated implant in terms of marginal bone level change over 5 years after final prosthetic delivery. Eligible subjects who provide their informed consent for participation will be enrolled into one of four groups, each sized to 250 individuals. They will be treated with the corresponding implant system assigned to the group. The allocation into a certain group is only driven by the subject's clinical and restorative requirement and standard of care at the enrolling study clinic. Each subject will be followed for 5 years after definitive prosthetic placement
Who can participate
Age range
18 Years – 65 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 signed the informed consent
* Subject is between 18 and 70 years of age
* Subjects presented with the need of single, multiple or full arch implant rehabilitation in any region of the mouth.
* Subject with medical and anatomical conditions that are in accordance with the applicable instructions for use (IFU).
* Subject with sufficient bone volume for implant placement.
* Subject is compliant with good oral hygiene as judged by the clinician.
Exclusion Criteria:
* Anatomical conditions discovered during surgery preventing the use of intended implant system.
* Subjects with history of allergy or adverse reactions to any materials used
* Uncontrolled diabetes (subjects with history of diabetes mismanagement and/or known A1c level above 8%)\*
* Heavy smokers (\>10 cigarettes per day)
* Severe bruxism or dysfunctional tendencies
* Previous oro-maxillo facial radiotheraphy
* Any ongoing application of interfering medication (steroid therapy, bisphosphonate, etc)
* Any disorders in the planned implant area such as previous tumors, chronic bone disease or previous radiation.
* Acute, untreated periodontitis in the planned implantation site or adjacent tissue.
* Infections in the planned implantation site or adjacent tissue.
* Documented complete remission of \>3 years if history of non-oral cancer.
* Pregnant or lactating women at the time of implant insertion. \*Assessment of A1C level is not required unless it is standard of care at the treating cli…
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
Marginal bone level change
Timeframe: Definitive prosthetic delivery to 5-years follow-up