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NCT07280260 | RECRUITING | Tooth Loss

Clinical Performance of Nobel N1 System
Sponsor:

Louisiana State University Health Sciences Center in New Orleans

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.

Condition or disease

Tooth Loss

Dental Implant

Intervention/treatment

Nobel N1 implant

Phase

PHASE4

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 50 participants
Masking : SINGLE
Primary Purpose : TREATMENT
Official Title : Effects of Early Loading Protocol on the Survival of the Nobel N1 Implant System: A Pilot Randomized Controlled Trial
Actual Study Start Date : 2025-12-15
Estimated Primary Completion Date : 2027-12-31
Estimated Study Completion Date : 2028-01-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
Clinical Performance of Nobel N1 System

Location Details

NCT07280260

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Louisiana

LSU School of Dentistry

New Orleans, Louisiana, United States, 70119