Clinical Performance of Nobel N1 System

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

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.

Study Overview

• Status: Recruiting
• Conditions: Tooth Loss; Dental Implant
• Intervention / Treatment: Device: Nobel N1 implant

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
• Enrollment (Estimated): 50
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Amir Nejat; Phone Number: 504-981-8283; Email: anejat@lsuhsc.edu
• Study Contact Backup: Name: Jeanne St Germain; Phone Number: 504-941-8276; Email: jstge1@lsuhsc.edu

Study Locations

• United States
  • Louisiana
    • New Orleans, Louisiana, United States, 70119
      • Recruiting
      • LSU School of Dentistry
      • Contact: Amir Nejat; Phone Number: 504-981-8283; Email: anejat@lsuhsc.edu
      • Contact: Jeanne St Germain; Phone Number: 504-941-8276; Email: jstge1@lsuhsc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Early loading; Delivery of the final crowns 6 weeks after the implant placement.	Device: Nobel N1 implant; A Nobel N1 implant will be placed and restored with a On 1 base
Other: Delayed loading; Delivery of the final crowns 12 weeks after the implant placement.	Device: Nobel N1 implant; A Nobel N1 implant will be placed and restored with a On 1 base

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Marginal bone loss	Marginal bone loss from the platform of the implant will be measured on Peri-apical X-rays and bitewings	6 months, 1 year
Probing depth	Probing depths will be measured at 6 surfaces	6 months, 1 year
Presence of sulcular suppuration on gentle probing	Presence or absence of suppuration will be evaluated upon gentle probing at 6 surfaces around the implant	6 months, 1 year
Presence of sulcular bleeding on gentle probing	Presence or absence of bleeding will be evaluated upon gentle probing at 6 surfaces around the implant	6 months, 1 year
Peri-implant Mucosal Tissue Index		Prosthetic delivery, 6 months, 1 year
Patient satisfaction questionnaire		Prosthetic delivery, 6 months, 1 year
Prosthetic complications		6 months, 1 year

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Estimated): December 15, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): January 30, 2028

Study Registration Dates

• First Submitted: November 18, 2025
• First Submitted That Met QC Criteria: December 11, 2025
• First Posted (Actual): December 12, 2025

Study Record Updates

• Last Update Posted (Actual): December 12, 2025
• Last Update Submitted That Met QC Criteria: December 11, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Dental implants; Edentulous; Tooth loss
• Additional Relevant MeSH Terms: Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Tooth Diseases; Tooth Loss; Mouth, Edentulous
• Other Study ID Numbers: 8328

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No