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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03613077
Acronym
BLX_NIS
Enrollment
153
Registered
2018-08-02
Start date
2018-05-14
Completion date
2025-08-21
Last updated
2026-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgical Operation With Implant of Artificial Internal Device

Keywords

Survival rate, Success rate, Straumann® BLX Implant Roxolid® SLActive®,

Brief summary

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

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

Interventions

PROCEDUREsurgical placement of an endosteal implant

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

Sponsors

Institut Straumann AG
Lead SponsorINDUSTRY

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

\-

Design outcomes

Primary

MeasureTime frameDescription
Implant success rate at one year post implant placement12 months follow-up period after implantationMeasured in percent
Implant survival rate at one year post implant placement12 months follow-up period after implantationMeasured in percent

Secondary

MeasureTime frameDescription
Prosthetic success at 12 months post implant placement12 months follow-up period after implantationMeasured in percent
Prosthetic survival at 12 months post implant placement12 months follow-up period after implantationMeasured in percent

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026