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NCT07280260PHASE4Recruiting

Clinical Performance of Nobel N1 System

Louisiana State University Health Sciences Center in New Orleans

Start Date

12/15/2025

Completion Date

1/30/2028

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.

Detailed 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 Criteria

Age Range: 18 years to No maximum

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

Interventions

DEVICE

Nobel N1 implant

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Conditions

Tooth LossDental Implant

Locations

LSU School of Dentistry

New Orleans, Louisiana 70119

United States