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Recruiting

NCT Number: NCT07280260

Clinical Performance of Nobel N1 System

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nobel N1 implant

Device

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

Primary outcomes

  1. Implant survival

    Time frame: 6 months, 1 year

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

  2. Misch implant success criteria

    Time frame: 6 months, 1 year

    Implant success will be measured according to Misch et al.

Secondary outcomes

  1. Marginal bone loss

    Time frame: 6 months, 1 year

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

  2. Probing depth

    Time frame: 6 months, 1 year

    Probing depths will be measured at 6 surfaces

  3. Presence of sulcular suppuration on gentle probing

    Time frame: 6 months, 1 year

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

  4. Presence of sulcular bleeding on gentle probing

    Time frame: 6 months, 1 year

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

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Amir Nejat

CONTACT

[email protected]

504-981-8283

Jeanne St Germain

CONTACT

[email protected]

504-941-8276

Sponsors and collaborators

Lead sponsor

Louisiana State University Health Sciences Center in New Orleans

Other

Collaborators

  • Envista (Nobel Biocare)

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Dec 12, 2025
Registry last updated
Dec 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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