Clinical Performance of Nobel N1 System

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-15

Study Completion Date

2028-01-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Tooth Loss Dental Implant

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The study is a two-arm, randomized prospective clinical trial. The randomization of the patients will be done after implant has been placed and if sufficient torque was obtained as outlined previously. At this point, using a computer generated table of random numbers, patients will be randomized into early loading and delayed loading group. Since it is not possible to predict ahead of time what the final torque will be at implant placement, a third group will comprise patients that receive implants that have lower torque that cannot be randomized. These patients will follow traditional one stage or two stage protocol for implant placement and delayed protocol. Irrespective of randomization and torque status and implant placement, all patients will be followed up as part of the study and analyzed based on the group to which they belong.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Early loading

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

Group Type ACTIVE_COMPARATOR

Nobel N1 implant

Intervention Type DEVICE

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

Delayed loading

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

Group Type OTHER

Nobel N1 implant

Intervention Type DEVICE

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

Interventions

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Nobel N1 implant

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No