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

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.

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Key information

Conditions

Dental Implant

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Urban Dental Center Kft, Budapest, Hungary

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Subject is ≥18 years of age
Signed of Informed Consent Form*
Signed Personal Data Processing (GDPR) Form**
Subject received Nobel Biocare N1 Concept System implants.

Exclusion criteria

none

Treatment and study plan

Primary outcomes

Marginal Bone Level and marginal bone levels changes

Time frame: 12-months post loading

Sponsors and collaborators

Lead sponsor

Nobel Biocare

Industry

Registry information

Official study title

A Retrospective Real-world Evidence Study Assessing the Safety and Effectiveness of the Nobel Biocare N1 Concept System.

Acronym: Evolution

Important dates

Study start: 2021
Primary completion: 2021
Study completion: 2021
First posted: Feb 3, 2021
Registry last updated: Oct 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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