Clinical Performance of Nobel N1 System
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorLouisiana State University Health Sciences Center in New Orleans
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
· 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.),
Trial design
Design model
Parallel
Treatments tested in this trial
Nobel N1 implant
DeviceA Nobel N1 implant will be placed and restored with a On 1 base
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Early loadingActive comparator 1 intervention
Group B: Delayed loadingOther 1 intervention
Trial outcomes
Primary outcomes
1
Implant survival
Implant survival will be measured if it is not failed and still present at time points
Time frame
6 months, 1 year2
Misch implant success criteria
Implant success will be measured according to Misch et al.
Time frame
6 months, 1 yearSecondary outcomes
1
Marginal bone loss
Marginal bone loss from the platform of the implant will be measured on Peri-apical X-rays and bitewings
Time frame
6 months, 1 year2
Probing depth
Probing depths will be measured at 6 surfaces
Time frame
6 months, 1 year3
Presence of sulcular suppuration on gentle probing
Presence or absence of suppuration will be evaluated upon gentle probing at 6 surfaces around the implant
Time frame
6 months, 1 year4
Presence of sulcular bleeding on gentle probing
Presence or absence of bleeding will be evaluated upon gentle probing at 6 surfaces around the implant
Time frame
6 months, 1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Louisiana State University Health Sciences Center in New Orleans
Lead sponsor
Envista (Nobel Biocare)
Collaborator
Source ClinicalTrials.gov