Clinical Performance of Nobel N1 System (NCT07280260) | Clinical Trial Compass
RecruitingPhase 4
Clinical Performance of Nobel N1 System
United States50 participantsStarted 2025-12-15
Plain-language summary
The purpose of the study is to evaluate whether N1 dental implants are successful when a final crown is placed on them at 6 weeks from implant placement surgery.
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:
* Males and females, age 18 or older
* Can provide an Informed Consent in English.
* Absence of a single posterior tooth in mandible or maxilla with presence of natural neighboring teeth (except for second molar which only requires presence of first molar)
* Presence of antagonist teeth
* Possibility and will for an immediate restoration.
* Systemic health recorded as an American Society of Anesthesiologists (ASA) I or II
Exclusion Criteria:
* · Unavailability to attend the follow-up visits.
* A systemic contraindication for oral surgical procedures; ASA III or IV.
* Pregnancy or nursing on screening or before the surgical procedure.
* Diseases that could alter healing or bone metabolism (uncontrolled diabetes, diagnostic osteoporosis, etc.),
* Taking medications that are altering healing or bone metabolism (bisphosphonates, long-time corticosteroids intake, RANK inhibitors, etc.)
* Alcohol or drug abuse.
* Current heavy smoking behavior (≥10 cigarettes/day).
* Radiation therapy to the head or neck region.
* Pathology in the implant planned sites that prevent implant placement.
* Current diagnosis of Diabetes, which is uncontrolled (\>7 HbA1C).
* Need for sinus lift or vertical bone augmentation
* Previously failed implant site
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: 6 months, 1 year
2
Misch implant success criteria
Timeframe: 6 months, 1 year
Trial details
NCT IDNCT07280260
SponsorLouisiana State University Health Sciences Center in New Orleans