A Non-Interventional Study to Document the Use of Straumann BLX Implants in Daily Dental Practice (BLX_NIS)

April 20, 2023 updated by: Institut Straumann AG
Prospective, multi-center, non-interventional observation to document the success and survival rates of Straumann BLX Implants used for tooth replacement in cleared indications up to 1 year after implant placement

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Objective of the study is to confirm the safety and performance of Straumann BLX Implants used for tooth replacement in cleared indications up to 12 months after implant placement. Implants used are Straumann® BLX Implant Roxolid® SLActive®. Regular Base (3.5 mm): implant diameters 3.75 and 4.5mm, in lengths 6, 8, 10, 12,14, 16 and 18 mm Wide Base (4.5 mm): diameter 5.5 mm in lengths 6, 8, 10 and 12 mm

Study Type

Observational

Enrollment (Actual)

153

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Mainz, Germany, 55128 Mainz
        • Mediplus Praxisklinik

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients seeking an implant supported restoration

Description

Inclusion Criteria:

  • Patients seeking an implant supported restoration
  • all patients with conditions that are in accordance with the IFU
  • Patients must provide their informed consent for study participation and must be willing and able to attend control visits
  • Patients need to be at least 18 years old

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Implant success rate at one year post implant placement
Time Frame: 12 months follow-up period after implantation
Measured in percent
12 months follow-up period after implantation
Implant survival rate at one year post implant placement
Time Frame: 12 months follow-up period after implantation
Measured in percent
12 months follow-up period after implantation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prosthetic success at 12 months post implant placement
Time Frame: 12 months follow-up period after implantation
Measured in percent
12 months follow-up period after implantation
Prosthetic survival at 12 months post implant placement
Time Frame: 12 months follow-up period after implantation
Measured in percent
12 months follow-up period after implantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Straumann AG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 14, 2018

Primary Completion (Actual)

February 2, 2020

Study Completion (Anticipated)

December 31, 2024

Study Registration Dates

First Submitted

July 11, 2018

First Submitted That Met QC Criteria

July 27, 2018

First Posted (Actual)

August 2, 2018

Study Record Updates

Last Update Posted (Actual)

April 21, 2023

Last Update Submitted That Met QC Criteria

April 20, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CR2017-03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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