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 range18 Years
SexALL
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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
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