Surgical Operation With Implant of Artificial Internal DeviceBLX_NISNCT03613077
A Non-Interventional Study to Document the Use of Straumann BLX Implants in Daily Dental Practice
An observational study of Surgical Operation With Implant of Artificial Internal Device, run by Institut Straumann AG at 1 site in Germany.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Operation With Implant of Artificial Internal Device
- What is being tested?
- surgical placement of an endosteal implant
- Type of treatment
- Surgery or procedure
- How many people
- 153 participants
- Where
- 1 siteGermany
- Study dates
- 14 May 2018to 21 Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients seeking an implant supported restoration
Who may be able to join
- 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
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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
- Being tested
- surgical placement of an endosteal implant
- Keywords
- Survival rate, Success rate, Straumann® BLX Implant Roxolid® SLActive®,
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgical placement of an endosteal implantProcedure or surgery
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
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant success rate at one year post implant placement
Measured in percent
Measured: 12 months follow-up period after implantation
Implant survival rate at one year post implant placement
Measured in percent
Measured: 12 months follow-up period after implantation
Secondary outcomes (2)
Prosthetic success at 12 months post implant placement
Measured in percent
Measured: 12 months follow-up period after implantation
Prosthetic survival at 12 months post implant placement
Measured in percent
Measured: 12 months follow-up period after implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2018
- Study start14 May 2018
- Primary completion2 Feb 2020
- Study completion21 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Operation With Implant of Artificial Internal DeviceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Straumann AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christian Walter, Prof. Dr.Dr., Principal investigator, Mediplus Praxisklinik
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03613077
- Sponsor's protocol ID
- CR2017-03
- Acronym
- BLX_NIS
- Status last verified
- Jan 2026
- First submitted
- 11 Jul 2018
- Last updated
- 9 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-Interventional Study to Document the Use of Straumann BLX Implants in Daily Dental Practice
- ClinicalTrials.gov ID
- NCT03613077
- Acronym / sponsor ID
- BLX_NIS / CR2017-03
- Keywords
- Survival rate, Success rate, Straumann® BLX Implant Roxolid® SLActive®,
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Institut Straumann AGIndustry (pharma, biotech, devices)
- Study start
- 14 May 2018 (actual)
- Primary completion
- 2 Feb 2020 (actual)
- Study completion
- 21 Aug 2025 (actual)
- First posted
- 2 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients seeking an implant supported restoration
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| surgical placement of an endosteal implantSubjects, 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 | Procedure or surgery | – |
Primary outcome
Implant success rate at one year post implant placement
Time frame: 12 months follow-up period after implantation
Measured in percent
Implant survival rate at one year post implant placement
Time frame: 12 months follow-up period after implantation
Measured in percent
2 secondary outcomes
Prosthetic success at 12 months post implant placement
Time frame: 12 months follow-up period after implantation
Prosthetic survival at 12 months post implant placement
Time frame: 12 months follow-up period after implantation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian Walter, Prof. Dr.Dr. principal investigator
Mediplus Praxisklinik
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgical Operation With Implant of Artificial Internal Device, run by Institut Straumann AG at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implant success rate at one year post implant placement (time frame: 12 months follow-up period after implantation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2026.