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Recruiting NCT07280260

Clinical Performance of Nobel N1 System

Phase IV Interventional Tooth Loss Dental Implant

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Nobel N1 implant.
Who it may be relevant to
Registry conditions: Tooth Loss, Dental Implant. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Effects of Early Loading Protocol on the Survival of the Nobel N1 Implant System: A Pilot Randomized Controlled Trial

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.

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.

Interventions

  • Device Nobel N1 implant
    A Nobel N1 implant will be placed and restored with a On 1 base

Primary outcome measures

  • Implant survival [Time frame: 6 months, 1 year]
  • Misch implant success criteria [Time frame: 6 months, 1 year]
Secondary outcome measures (7)
  • Marginal bone loss [Time frame: 6 months, 1 year]
  • Probing depth [Time frame: 6 months, 1 year]
  • Presence of sulcular suppuration on gentle probing [Time frame: 6 months, 1 year]
  • Presence of sulcular bleeding on gentle probing [Time frame: 6 months, 1 year]
  • Peri-implant Mucosal Tissue Index [Time frame: Prosthetic delivery, 6 months, 1 year]
  • Patient satisfaction questionnaire [Time frame: Prosthetic delivery, 6 months, 1 year]
  • Prosthetic complications [Time frame: 6 months, 1 year]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • LSU School of Dentistry — New Orleans

Identifiers

NCT: NCT07280260 · 8328

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗