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

NCT07119151 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 94

Last updated 2025-08-12

No results posted yet for this study

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.

Conditions

  • Edentulism
  • Dental Implant
  • Atrophy of Edentulous Alveolar Ridge
  • Atrophy of Edentulous Mandibular Alveolar Ridge
  • Atrophy of Edentulous Maxillary Alveolar Ridge

Interventions

DEVICE

Dental Implant

Dental Implant placement and loading.

Sponsors & Collaborators

  • Federal University of Uberlandia

    collaborator OTHER

  • UNESP, Câmpus de Araraquara

    collaborator OTHER

  • Faculdade ILAPEO

    collaborator UNKNOWN

  • Neodent

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-01
Primary Completion
2028-12-31
Completion
2028-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07119151 on ClinicalTrials.gov