NCT03613077

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
153

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 14, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 11, 2018

Completed
22 days until next milestone

First Posted

Study publicly available on registry

August 2, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 2, 2020

Completed
5.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 21, 2025

Completed
Last Updated

January 9, 2026

Status Verified

January 1, 2026

Enrollment Period

1.7 years

First QC Date

July 11, 2018

Last Update Submit

January 7, 2026

Conditions

Surgical Operation With Implant of Artificial Internal Device

Keywords

Survival rateSuccess rateStraumann® BLX Implant Roxolid® SLActive®,

Outcome Measures

Primary Outcomes (2)

  • Implant success rate at one year post implant placement

    Measured in percent

    12 months follow-up period after implantation

  • Implant survival rate at one year post implant placement

    Measured in percent

    12 months follow-up period after implantation

Secondary Outcomes (2)

  • Prosthetic success at 12 months post implant placement

    12 months follow-up period after implantation

  • Prosthetic survival at 12 months post implant placement

    12 months follow-up period after implantation

Interventions

surgical placement of an endosteal implantPROCEDURE

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients seeking an implant supported restoration

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mediplus Praxisklinik

Mainz, 55128 Mainz, Germany

Location

Study Officials

  • Christian Walter, Prof. Dr.Dr.

    Mediplus Praxisklinik

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 11, 2018

First Posted

August 2, 2018

Study Start

May 14, 2018

Primary Completion

February 2, 2020

Study Completion

August 21, 2025

Last Updated

January 9, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)