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Clinical Performance of Nobel N1 System

Clinical Performance of Nobel N1 System

Recruiting
18 years and older
All
Phase 4

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Overview

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.

Description

This study aims to evaluate the survival and stability of the Nobel N1 dental implant and its accompanying crown over a one-year period when the crown is placed either 6 or 12 weeks after implant placement. The Nobel N1 implant is an FDA-approved, newly designed implant featuring an innovative surgical placement protocol intended to minimize bone trauma, promote faster integration, and potentially allow for the placement of final crowns earlier-at 6 weeks instead of the traditional 4 to 5 months. This study will enroll adult participants who are missing a single tooth in the back of the mouth.

Eligibility

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

Study details
    Tooth Loss
    Dental Implant

NCT07280260

Louisiana State University Health Sciences Center in New Orleans

31 January 2026

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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