Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04736771 |
| Other study ID # |
T-193 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
May 18, 2021 |
| Est. completion date |
September 16, 2021 |
Study information
| Verified date |
October 2021 |
| Source |
Nobel Biocare |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Standard medical and dental forms from all subjects (i.e., adults ≥18 years old in need of a
dental implant) who have been treated for CS Tiger Ultra Implant TCC RP dental implant
treatment at the participating Clinics will be reviewed and clinical data will be obtained,
only upon the receipt of Ethical Committee's approval and upon subject's signature of the
corresponding Informed Consent Form.
All raw study data will be de-identified and corresponding subject information recorded in
the data accrual system (e-CRF Smart Trial). Information recorded by the researcher shall not
identify the subject and no individually identifiable data elements shall be recorded. The
researcher shall receive a link to log in to e CRF system. The researcher will be asked to
create an account and every log-in attempt into the system shall be controlled by an unique
code. Radiographic measurements of marginal bone level mesial and distal to the implant (at
time of surgery, implant loading and 12-months follow-up post-loading) carried out according
to the standard practice of the clinic will be collected for the assessment of the marginal
bone levels changes. Data will be anonymized before the x-ray collection.
An independent radiologist shall be responsible for the evaluation of the radiographic data.
The Sponsor shall send to the radiologist all corresponding radiographic files entitled by
study code, clinic and patient number, implant position and implant characteristics (diameter
and/or length - where available) together with an Excel sheet where the Radiologist can
accurately track the corresponding bone level measurements.
Description:
This study is a retrospective observational multi-center study. It will include data from 70
up to 100 subjects, treated with the N1 Concept System. The study will be conducted in up to
six European centers (Appendix I - Participating Institutions).
The study will collect clinical and radiographic data related to the surgery and up to
12-months after loading (a time window of ± 3-months is accepted).
Study subjects will be consecutively included provided they meet all of the inclusion
criteria and none of the exclusion criteria.
All participating subjects must have signed the Informed Consent Form together with a
separate Consent Form regarding personal data processing (if not waived by the corresponding
Ethical Committee). Retrospective data collection will only start after signatures have been
provided.
The investigator will check subjects' medical and dental chart and assign a study ID number
to each subject. The corresponding study required information will be de-identified and
entered into the electronic study database.
All x-ray images, from the area of treatment, that were made up until 12-months after implant
loading will be de-identified before uploaded to the study database or otherwise sent to the
sponsor.
No personal/confidential information (e.g.: full name or initials, date of birth, social
security number, etc.) that could reveal subject's identity will be recorded in the study
database.
Endpoints
Primary endpoint The primary endpoint is to evaluate the marginal bone level change of the N1
Concept System from loading to 12-months post loading. Patients with matched readable
radiographs are included.
Secondary endpoints
- Implant survival and success rates at 12-months after loading.
- Soft tissue healing parameters (i.e. bleeding index, plaque index, etc.) at 12-months
after loading.
- Safety recorded by AE, SAE, ADE, SADE, USADE, and DD.
