Actively Recruiting
Effects of Early Loading Protocol on the Survival of the Nobel N1 Implant System: A Pilot Randomized Controlled Trial
Led by Louisiana State University Health Sciences Center in New Orleans · Updated on 2025-12-12
50
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
Sponsors
L
Louisiana State University Health Sciences Center in New Orleans
Lead Sponsor
E
Envista (Nobel Biocare)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the survival and stability of the Nobel N1 dental implant and its crown when the crown is placed either 6 or 12 weeks after implant placement. This study focuses on adults missing a single tooth in the back of the mouth. The Nobel N1 implant is FDA-approved and designed with a surgical technique that reduces bone trauma and aims to speed up integration, potentially allowing earlier final crown placement compared to traditional methods. Participants will receive a Nobel N1 implant restored with an On 1 base. They will be randomly assigned to one of two groups: one group will have their final crown placed 6 weeks after implant surgery (early loading), and the other group will have it placed 12 weeks after (delayed loading). This study is a pilot randomized controlled trial assessing the effects of early loading on implant survival. During the study, participants will be monitored over a one-year period with assessments at 6 months and 1 year. Researchers will evaluate implant survival, bone loss, probing depth, signs of inflammation or infection around the implant, tissue health, patient satisfaction, and any prosthetic complications. Follow-up visits will include clinical evaluations and questionnaires to track outcomes and safety throughout the study duration.
CONDITIONS
Brief Title
Clinical Performance of Nobel N1 System
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males and females aged 18 or older
- Able to provide informed consent in English
- Missing a single posterior tooth in the lower or upper jaw with natural neighboring teeth (except second molar requiring first molar presence)
- Presence of opposing teeth
- Eligible and willing for immediate restoration
- Good general health classified as ASA I or II
You will not qualify if you...
- Unable to attend follow-up visits
- Medical conditions contraindicating oral surgery; ASA III or IV
- Pregnant or nursing at screening or before surgery
- Diseases affecting healing or bone metabolism (e.g., uncontrolled diabetes, osteoporosis)
- Taking medications affecting healing (e.g., bisphosphonates, long-term corticosteroids, RANK inhibitors)
- Alcohol or drug abuse
- Heavy smoking (10 or more cigarettes per day)
- Radiation therapy to head or neck
- Pathology at implant site preventing placement
- Uncontrolled diabetes (HbA1C >7)
- Need for sinus lift or vertical bone augmentation
- Previous implant failure at site
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants receive the Nobel N1 dental implant placed using an innovative surgical protocol designed to minimize bone trauma and promote faster integration.
1 visit (in-person)
Duration - 6 to 12 weeks
Participants have the final crown placed on the implant either 6 weeks or 12 weeks after implant placement depending on their assigned group.
1 crown delivery visit (in-person)
Duration - Up to 1 year
Participants are monitored for implant survival, stability, bone loss, probing depth, tissue health, and prosthetic complications over a one-year period.
Follow-up visits at 6 months and 1 year (in-person)
Trial Site Locations
Total: 1 location
1
LSU School of Dentistry
New Orleans, Louisiana, United States, 70119
Actively Recruiting
Research Team
A
Amir Nejat
J
Jeanne St Germain
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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