Multicentric Prospective Observational Study of Neodent Implantable Devices of Helix Short System

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.

NCT Number	NCT07119151
Lead Sponsor	Neodent Collaborators: Federal University of Uberlandia, UNESP, Câmpus de Araraquara, Faculdade ILAPEO
Conditions	Edentulism, Dental Implant, Atrophy of Edentulous Alveolar Ridge, Atrophy of Edentulous Mandibular Alveolar Ridge, Atrophy of Edentulous Maxillary Alveolar Ridge
Enrollment	94 participants
Start Date	2025-09-01
Primary Completion	2028-12 (estimated)
Study Completion	2028-12 (estimated)
Updated on ClinicalTrials.gov	2025-08-12