Clinical Performance of Nobel N1 System
Purpose
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.
Conditions
- Tooth Loss
- Dental Implant
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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 Design
- Phase
- Phase 4
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- 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.
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Active Comparator Early loading |
Delivery of the final crowns 6 weeks after the implant placement. |
|
|
Other Delayed loading |
Delivery of the final crowns 12 weeks after the implant placement. |
|
Recruiting Locations
LSU School of Dentistry
New Orleans 4335045, Louisiana 4331987 70119
New Orleans 4335045, Louisiana 4331987 70119
More Details
- Status
- Recruiting
- Sponsor
- Louisiana State University Health Sciences Center in New Orleans
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.