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RecruitingNCT07280260Updated Aug 27, 2026

Clinical Performance of Nobel N1 System

A Phase 4 interventional study of Nobel N1 implant in Tooth Loss and Dental Implant, sponsored by Louisiana State University Health Sciences Center in New Orleans. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-27.

Sponsored by Louisiana State University Health Sciences Center in New Orleans · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Started Dec 2025; still recruiting 10 months later.
Phase
Phase 4
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Tooth Loss
  • Dental Implant

Keywords

  • Tooth loss
  • Edentulous
  • Dental implants
03

In context

Tooth Loss

165 studies on the registry are indexed under Tooth Loss; 44 are open to participants now.

This study's planned enrollment of 50 is above the median of 30 across 120 interventional studies indexed under Tooth Loss.

Browse Tooth Loss studies →

Lead sponsor

Louisiana State University Health Sciences Center in New Orleans is the lead sponsor of 72 studies on the registry; 12 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Males and females, age 18 or older

    • Can provide an 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 (ASA) I or II

Exclusion criteria

Exclusion Criteria:

    • Unavailability to attend the follow-up visits.

      • A systemic for oral surgical procedures; .
      • 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 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 ).
      • Need for sinus lift or vertical bone augmentation
      • Previously failed implant site
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
50 participants (estimated)

Study arms

  • Active comparator
    Early loading

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

    Device: Nobel N1 implant

  • Other
    Delayed loading

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

    Device: Nobel N1 implant

Interventions

  • DeviceNobel N1 implant

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

06

What researchers measure

Primary outcomes

  1. Implant survival

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

    Time frame: 6 months, 1 year

  2. Misch implant success criteria

    Implant success will be measured according to Misch et al.

    Time frame: 6 months, 1 year

Secondary outcomes

  1. Marginal bone loss

    Marginal bone loss from the platform of the implant will be measured on Peri-apical X-rays and bitewings

    Time frame: 6 months, 1 year

  2. Probing depth

    Probing depths will be measured at 6 surfaces

    Time frame: 6 months, 1 year

  3. Presence of sulcular suppuration on gentle probing

    Presence or absence of suppuration will be evaluated upon gentle probing at 6 surfaces around the implant

    Time frame: 6 months, 1 year

  4. Presence of sulcular bleeding on gentle probing

    Presence or absence of bleeding will be evaluated upon gentle probing at 6 surfaces around the implant

    Time frame: 6 months, 1 year

  5. Peri-implant Mucosal Tissue Index

    Time frame: Prosthetic delivery, 6 months, 1 year

  6. Patient satisfaction questionnaire

    Time frame: Prosthetic delivery, 6 months, 1 year

  7. Prosthetic complications

    Time frame: 6 months, 1 year

07

Study locations

1 of 1 sites recruiting
  • LSU School of Dentistry
    New Orleans, Louisiana 70119, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07280260
Lead sponsor
Louisiana State University Health Sciences Center in New Orleans
Collaborators
Envista (Nobel Biocare)
Responsible party
Sponsor
First posted
Dec 12, 2025
Start date
Dec 15, 2025
Primary completion
Dec 31, 2027 (estimated)
Completion
Jan 30, 2028 (estimated)
Last update
Aug 27, 2026

Study contacts

Amir Nejat
Contact
anejat@lsuhsc.edu
504-981-8283
Jeanne St Germain
Contact
jstge1@lsuhsc.edu
504-941-8276

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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