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

Active, not recruiting

• Conditions: Surgical Operation With Implant of Artificial Internal Device

• Registration Number: NCT03613077
• Lead Sponsor: Institut Straumann AG

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

Study Timeline

• Study Start: 2018-05-14
• Study First Submitted: 2018-07-11
• Study First Submitted QC: 2018-07-27
• Study First Posted: 2018-08-02
• Primary Completion: 2020-02-02
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-18
• Last Update Posted: 2024-07-19
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 153

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Implant survival rate at one year post implant placement	12 months follow-up period after implantation	Measured in percent
Implant success rate at one year post implant placement	12 months follow-up period after implantation	Measured in percent

Secondary Outcome Measures

Name	Time	Method
Prosthetic success at 12 months post implant placement	12 months follow-up period after implantation	Measured in percent
Prosthetic survival at 12 months post implant placement	12 months follow-up period after implantation	Measured in percent

Trial Locations

Locations (1)

Mediplus Praxisklinik; 🇩🇪 Mainz, Germany