Trials / Not Yet Recruiting
Not Yet RecruitingNCT07119151
Multicentric Prospective Observational Study of Neodent Implantable Devices of Helix Short System
- Status
- Not Yet Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 94 (estimated)
- Sponsor
- Neodent · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| DEVICE | Dental Implant | Dental Implant placement and loading. |
Timeline
- Start date
- 2025-09-01
- Primary completion
- 2028-12-01
- Completion
- 2028-12-01
- First posted
- 2025-08-12
- Last updated
- 2025-08-12
Source: ClinicalTrials.gov record NCT07119151. Inclusion in this directory is not an endorsement.