Clinical Performance of Nobel N1 System | NCT07280260

Studies
Clinical Performance of Nobel N1 System

NCT07280260

Sponsor

Louisiana State University Health Sciences Center in New Orleans

Status

Recruiting

Last Update Posted

Dec 12, 2025Actual

Enrollment

50Estimated

Phase

Phase 4

Conditions

Tooth Loss
Dental Implant

Interventions

Nobel N1 implant

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 15, 2025Estimated

Primary Completion Date

Dec 31, 2027Estimated

Completion Date

Jan 30, 2028Estimated

First Submitted Date

Nov 18, 2025

First Submission Date that Met QC Criteria

Dec 11, 2025

First Posted Date

Dec 12, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 11, 2025

Last Update Posted Date

Dec 12, 2025Actual

Name	Class
Envista (Nobel Biocare)	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Nobel N1 implant	Device	A Nobel N1 implant will be placed and restored with a On 1 base	Delayed loading Early loading

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Amir Nejat	Contact	504-981-8283		anejat@lsuhsc.edu
Jeanne St Germain	Contact	504-941-8276		jstge1@lsuhsc.edu

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
LSU School of Dentistry	Recruiting	New Orleans	Louisiana	70119	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D016388	Tooth Loss
D009066	Mouth, Edentulous

ID	Term
D010510	Periodontal Diseases
D009059	Mouth Diseases
D009057	Stomatognathic Diseases
D014076	Tooth Diseases

Intervention Model Description

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.