Clinical Performance of Nobel N1 System

Louisiana State University

Status and phase: Enrolling; Phase 4

Conditions: Tooth Loss; Dental Implant

Treatments: Device: Nobel N1 implant

Study type: Interventional

Funder types: Other

Identifiers

NCT07280260

8328

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Early loading

Active Comparator group

Description:

Delivery of the final crowns 6 weeks after the implant placement.

Treatment:

Device: Nobel N1 implant

Delayed loading

Other group

Description:

Delivery of the final crowns 12 weeks after the implant placement.

Treatment:

Device: Nobel N1 implant