Clinical Performance of Nobel N1 System

NCT07280260 | Recruiting Phase 4 FDA Device

• 1 other identifier: 8328
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Tooth Loss; Dental Implant

Keywords

Tooth loss; Edentulous; Dental implants

Outcome Measures

Primary Outcomes (2)

• Implant survival

  Implant survival will be measured if it is not failed and still present at time points

  6 months, 1 year

• Misch implant success criteria

  Implant success will be measured according to Misch et al.

  6 months, 1 year

Secondary Outcomes (7)

• Marginal bone loss

  6 months, 1 year

• Probing depth

  6 months, 1 year

• Presence of sulcular suppuration on gentle probing

  6 months, 1 year

• Presence of sulcular bleeding on gentle probing

  6 months, 1 year

• Peri-implant Mucosal Tissue Index

  Prosthetic delivery, 6 months, 1 year

Study Arms (2)

Early loading

ACTIVE COMPARATOR

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

Device: Nobel N1 implant

Delayed loading

OTHER

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

Device: Nobel N1 implant

Interventions

Nobel N1 implant DEVICE

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

Delayed loading; Early loading

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• · 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

Sponsors & Collaborators

• Envista (Nobel Biocare): collaborator
• Louisiana State University Health Sciences Center in New Orleans: lead

Study Sites (1)

LSU School of Dentistry

New Orleans, Louisiana, 70119, United States

RECRUITING

MeSH Terms

Conditions

Tooth Loss; Mouth, Edentulous

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Tooth Diseases

Central Study Contacts

Amir Nejat

CONTACT

504-981-8283; anejat@lsuhsc.edu

Jeanne St Germain

CONTACT

504-941-8276; jstge1@lsuhsc.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: December 12, 2025
• Study Start: December 15, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): January 30, 2028
• Last Updated: December 12, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)