Study Assessing the Safety and Effectiveness of the Nobel Biocare N1 Concept System. (Evolution)

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.