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OpenTrials
Completed

NCT Number: NCT03613077

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

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

Completed

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Key information

Conditions

Surgical Operation With Implant of Artificial Internal Device

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mediplus Praxisklinik

Mainz, 55128 Mainz, Germany

About this study

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

Who can participate

Healthy volunteers accepted: No

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

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

-

Treatment and study plan

surgical placement of an endosteal implant

Procedure

Subjects, male or female at least 18 years old, with the need of dental implant therapy and restoration according to the cleared indications for the implant

Primary outcomes

  1. Implant success rate at one year post implant placement

    Time frame: 12 months follow-up period after implantation

    Measured in percent

  2. Implant survival rate at one year post implant placement

    Time frame: 12 months follow-up period after implantation

    Measured in percent

Secondary outcomes

  1. Prosthetic success at 12 months post implant placement

    Time frame: 12 months follow-up period after implantation

    Measured in percent

  2. Prosthetic survival at 12 months post implant placement

    Time frame: 12 months follow-up period after implantation

    Measured in percent

Sponsors and collaborators

Lead sponsor

Institut Straumann AG

Industry

Registry information

Acronym: BLX_NIS

Important dates

Study start
2018
Primary completion
2020
Study completion
2025
First posted
Aug 2, 2018
Registry last updated
Jan 9, 2026

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.