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

NCT04736771 | Completed

• 1 other identifier: T-193
• Study Type: observational
• Target: 95
• Locations: 3 countries
• Sites: 3

Brief 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.

Conditions

Dental Implant

Keywords

implant site preparation tools, implant system

Outcome Measures

Primary Outcomes (1)

• Marginal Bone Level and marginal bone levels changes

  12-months post loading

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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 in the period from April 2019 until December 2019 at the corresponding participant Clinics

You may qualify if:

• 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.

Sponsors & Collaborators

• Nobel Biocare: lead

Study Sites (3)

Urban Dental Center Kft

Budapest, Hungary

Location

Studio Ban Mancini Fabbri

Cattolica, Italy

Location

Staas & Bergmans

's-Hertogenbosch, Netherlands

Location

Related Publications (1)

• Fabbri G, Staas T, Urban I. A Retrospective Observational Study Assessing the Clinical Outcomes of a Novel Implant System with Low-Speed Site Preparation Protocol and Tri-Oval Implant Geometry. J Clin Med. 2022 Aug 18;11(16):4859. doi: 10.3390/jcm11164859.

  PMID: 36013098 DERIVED

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2021
• First Posted: February 3, 2021
• Study Start: May 18, 2021
• Primary Completion: September 10, 2021
• Study Completion: September 16, 2021
• Last Updated: October 11, 2021

Record last verified: 2021-10

Locations

IT (1); NL (1); HU (1)