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Multicentric Prospective Observational Study of Neodent Implantable Devices of Helix Short System
Sponsor: Neodent
Summary
This is a post-market prospective observational study to prospectively collect clinical data to confirm the long-term safety and clinical performance of implants and abutments Helix Short in a daily dental practice setting, by means of success and survival rates of these devices. Additionally, from the collected data, the study aims to identify previously unknown side-effects and monitor the known side-effects and contraindications stated on the IFU, identify and analyze emerging risks on the basis of factual evidence, and ensure the continued acceptability of the benefit-risk ratio with the intent to verify that the intended purpose is correct for all JJGC products involved in the procedure that get in contact with the patient.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
94
Start Date
2025-09-01
Completion Date
2028-12
Last Updated
2025-08-12
Healthy Volunteers
No
Conditions
Interventions
Dental Implant
Dental Implant placement and loading.