Nobel N1 dental implant with early 6-week crown placement

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

This test will see if adults missing a single back tooth can get a final crown on a Nobel N1 dental implant 6 weeks after implant surgery.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Louisiana State University Health Sciences Center in New Orleans (other)
• Drugs / interventions: Radiation
• Locations: 1 site (New Orleans, Louisiana)
• Trial ID: NCT07280260 on ClinicalTrials.gov

What this trial studies

Adults missing a single posterior tooth will receive a Nobel N1 implant using a protocol designed to minimize bone trauma. Participants will have their final crown placed at either 6 weeks or 12 weeks after implant placement and will be followed for one year. Outcomes include implant survival and measures of implant stability and function over the 12-month period. The Nobel N1 is an FDA-cleared design intended to promote faster integration and potentially allow earlier restoration than traditional protocols.

Who should consider this trial

Good fit: Adults 18 or older who are generally healthy (ASA I–II), have a single missing posterior tooth with natural neighboring and opposing teeth, and can attend follow-up visits are the intended candidates.

Not a fit: Patients with conditions or medications that impair healing (for example uncontrolled diabetes, osteoporosis treatments, long-term corticosteroids), heavy smokers, pregnant or nursing individuals, or those unable to attend follow-ups are unlikely to benefit.

Why it matters

Potential benefit: If successful, patients could receive their permanent crown much sooner (around 6 weeks) and regain chewing function and appearance faster than with traditional timing.

How similar studies have performed: Early-loading protocols for dental implants have shown success in prior studies, but the Nobel N1 design and formal testing of a 6-week final crown timing are relatively new.

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

Where this trial is running

New Orleans, Louisiana

• LSU School of Dentistry — New Orleans, Louisiana, United States (RECRUITING)

Study contacts

• Study coordinator: Amir Nejat

Conditions: Tooth Loss, Dental Implant, Tooth loss, Edentulous, Dental implants