Nobel N1 Implant for Tooth Loss

Overseen By Jeanne St Germain

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Louisiana State University Health Sciences Center in New Orleans

Must not be taking: Bisphosphonates, Corticosteroids, RANK inhibitors

Disqualifiers: Uncontrolled diabetes, Heavy smoking, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of Nobel N1 dental implants when the final crown is placed 6 weeks after implant surgery. Researchers aim to determine if this timing is successful for individuals who have lost a single back tooth and have healthy neighboring and opposing teeth. The trial includes two groups: one receives the crown at 6 weeks, and the other at 12 weeks after implant placement. Individuals who have lost a single back tooth and are in good general health might be suitable candidates. As a Phase 4 trial, the treatment is already FDA-approved and proven effective, helping to understand its benefits for more patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are on medications that affect healing or bone metabolism, like bisphosphonates or long-term corticosteroids, you may not be eligible to participate.

What is the safety track record for the Nobel N1 System?

Research has shown that the Nobel N1 dental implant system is generally safe for people. A retrospective study found that 98% of these implants remained in place and functioned well during the last check-up, indicating a high success rate. Doctors expressed satisfaction with the implants' performance.

Another study found no bone loss around the implant, suggesting good acceptance by the body. While every treatment carries some risks, these findings indicate that the Nobel N1 system is a safe choice for dental implants. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

The Nobel N1 Implant for tooth loss is unique because it offers two innovative approaches for placing crowns on dental implants. Unlike traditional methods, which often require longer healing times, the "Early loading" approach allows for crowns to be placed just six weeks after implant placement, potentially speeding up the entire treatment process. Meanwhile, the "Delayed loading" option still reduces the wait by delivering crowns after 12 weeks, which can provide more flexibility and convenience for patients. Researchers are excited about these options because they could significantly improve the efficiency and patient experience of dental implant procedures.

What evidence suggests that the Nobel N1 System is effective for tooth loss?

Research has shown that the Nobel N1 dental implant system performs exceptionally well. One study found that 98% of these implants last a long time, proving their strength and dependability. Another study found that 97.3% of the implants remained in place after one year, further confirming their success. This trial will compare two approaches: early loading, where final crowns are delivered 6 weeks after implant placement, and delayed loading, where final crowns are delivered 12 weeks after implant placement. These findings suggest that Nobel N1 implants effectively replace missing teeth and provide a solid base for dental crowns. Overall, the evidence supports the effectiveness of the Nobel N1 system in treating tooth loss. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

This trial is for adults over 18 who have lost a single tooth and can consent in English. They should be generally healthy (ASA I or II), have natural neighboring teeth, want immediate restoration, and possess opposing teeth. Heavy smokers, pregnant/nursing women, those with uncontrolled diabetes (>7 HbA1C), or on certain medications are excluded.

Inclusion Criteria

I am 18 years old or older.

I can understand and sign the consent form in English.

I am missing one back tooth, but my other teeth are natural.

Exclusion Criteria

Alcohol or drug abuse

Current heavy smoking behavior (≥10 cigarettes/day)

Pregnancy or nursing on screening or before the surgical procedure

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Nobel N1 dental implant, with crowns placed at either 6 or 12 weeks post-implantation

12 weeks

Follow-up

Participants are monitored for implant survival, success, and other dental health indicators

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Nobel N1 System

Trial Overview

The study tests the success of Nobel N1 dental implants when a final crown is placed at 6 weeks after implant surgery. It aims to assess how well these implants integrate into the jawbone and support crowns in replacing missing teeth.

How Is the Trial Designed?

Group I: Delayed loading Experimental Treatment 1 Intervention

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

Group II: Early loading Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Louisiana State University Health Sciences Center in New Orleans

Lead Sponsor

Trials

123

Recruited

42,400+

Envista (Nobel Biocare)

Collaborator

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07280260

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 ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9410172/

A Retrospective Observational Study Assessing the ...

At the last follow-up, the implant survival rate was 98.0%. Clinician satisfaction with the novel concept system was high. The novel concept ...

3.

nobelbiocare.com

nobelbiocare.com/en-int/news/highest-level-evidence-meta-analysis-of-a-single-implant-brand-confirms-clinical-success-of

Highest-level evidence: meta-analysis of a single implant ...

A new systematic review and meta-analysis provides the strongest evidence to date confirming the high efficacy of Nobel Biocare implants with the TiUnite ...

4.

onlinelibrary.wiley.com

onlinelibrary.wiley.com/doi/10.1111/clr.18_13855

EAO‐423 / OC‐CI‐006 | Safety and effectiveness of the N1 ...

Of the 165 implants 4 failed, yielding the 1-year survival rate of 97.3%. Analyses including marginal bone levels, implant success, soft tissue ...

5.

trial.medpath.com

trial.medpath.com/clinical-trial/737621c4d356410d/nct07280260-early-loading-nobel-n1-implant-survival

Clinical Performance of Nobel N1 System | MedPath

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 ...

6.

nobelbiocare.com

nobelbiocare.com/sites/g/files/wdvifx201/files/GMT82028-Fabbri%20et%20al%202022_N1.pdf

one versatile and simplified solution for clinical success in ...

A Retrospective Observational Study Assessing the Clinical Outcomes of a Novel Implant System With Low-Speed Site Preparation ... No bone loss from implant.

7.

open.library.ubc.ca

open.library.ubc.ca/soa/cIRcle/collections/ubctheses/24/items/1.0071140

Clinical outcomes of the Nobel Active dental implant system ...

Results: NobelActive implants demonstrated a survival rate of 94.4% with 7 of the 64 patients experiencing one failure. Variables considered risk factors did ...