Tooth LossPhase 4NCT07280260
Clinical Performance of Nobel N1 System
A Phase 4 study testing Nobel N1 implant in people with Tooth Loss and Dental Implant, run by Louisiana State University Health Sciences Center in New Orleans at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tooth Loss, Dental Implant
- What is being tested?
- Nobel N1 implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2025to 30 Jan 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- · 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.
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
LSU School of Dentistry
New Orleans, Louisiana, 70119
Amir Nejat, 504-981-8283, anejat@lsuhsc.edu
Jeanne St Germain, 504-941-8276, jstge1@lsuhsc.edu
About this study
Official title: Effects of Early Loading Protocol on the Survival of the Nobel N1 Implant System: A Pilot Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Tooth Loss, Dental Implant
- Being tested
- Nobel N1 implant
- Keywords
- Tooth loss, Edentulous, Dental implants
- Medical subject headings
- Tooth Loss, Mouth, Edentulous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nobel N1 implantDevice
A Nobel N1 implant will be placed and restored with a On 1 base
| Study group | Role | What they receive |
|---|---|---|
| Early loading | Active comparator | Delivery of the final crowns 6 weeks after the implant placement. Receives: Device: Nobel N1 implant |
| Delayed loading | Other | Delivery of the final crowns 12 weeks after the implant placement. Receives: Device: Nobel N1 implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant survival
Implant survival will be measured if it is not failed and still present at time points
Measured: 6 months, 1 year
Misch implant success criteria
Implant success will be measured according to Misch et al.
Measured: 6 months, 1 year
Secondary outcomes (7)
Marginal bone loss
Marginal bone loss from the platform of the implant will be measured on Peri-apical X-rays and bitewings
Measured: 6 months, 1 year
Probing depth
Probing depths will be measured at 6 surfaces
Measured: 6 months, 1 year
Presence of sulcular suppuration on gentle probing
Presence or absence of suppuration will be evaluated upon gentle probing at 6 surfaces around the implant
Measured: 6 months, 1 year
Presence of sulcular bleeding on gentle probing
Presence or absence of bleeding will be evaluated upon gentle probing at 6 surfaces around the implant
Measured: 6 months, 1 year
Peri-implant Mucosal Tissue Index
Measured: Prosthetic delivery, 6 months, 1 year
Patient satisfaction questionnaire
Measured: Prosthetic delivery, 6 months, 1 year
Prosthetic complications
Measured: 6 months, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2025
- Study start15 Dec 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Louisiana State University Health Sciences Center in New Orleans
- Sponsor type
- University, hospital or other
- Collaborators
- Envista (Nobel Biocare)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07280260
- Sponsor's protocol ID
- 8328
- Status last verified
- Aug 2026
- First submitted
- 18 Nov 2025
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Early Loading Protocol on the Survival of the Nobel N1 Implant System: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07280260
- Acronym / sponsor ID
- 8328
- Conditions
- Tooth Loss, Dental Implant
- Keywords
- Tooth loss, Edentulous, Dental implants
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Louisiana State University Health Sciences Center in New OrleansUniversity, hospital or other
- Collaborators
- Envista (Nobel Biocare)
- Study start
- 15 Dec 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 Jan 2028 (estimated)
- First posted
- 12 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Early loading | Active comparator | Device: Nobel N1 implantDelivery of the final crowns 6 weeks after the implant placement. |
| Delayed loading | Other | Device: Nobel N1 implantDelivery of the final crowns 12 weeks after the implant placement. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Males and females, age 18 or older
Key exclusion criteria (12 listed)
- · Unavailability to attend the follow-up visits.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nobel N1 implantA Nobel N1 implant will be placed and restored with a On 1 base | Device | Delayed loading, Early loading |
Primary outcome
Implant survival
Time frame: 6 months, 1 year
Implant survival will be measured if it is not failed and still present at time points
Misch implant success criteria
Time frame: 6 months, 1 year
Implant success will be measured according to Misch et al.
7 secondary outcomes
Marginal bone loss
Time frame: 6 months, 1 year
Probing depth
Time frame: 6 months, 1 year
Presence of sulcular suppuration on gentle probing
Time frame: 6 months, 1 year
Presence of sulcular bleeding on gentle probing
Time frame: 6 months, 1 year
Peri-implant Mucosal Tissue Index
Time frame: Prosthetic delivery, 6 months, 1 year
Patient satisfaction questionnaire
Time frame: Prosthetic delivery, 6 months, 1 year
Prosthetic complications
Time frame: 6 months, 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nobel N1 implant in people with Tooth Loss and Dental Implant, run by Louisiana State University Health Sciences Center in New Orleans at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amir Nejat (504-981-8283, anejat@lsuhsc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implant survival (time frame: 6 months, 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.