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.
Patients with atrophic maxilla and mandible, who need of one or more dental implants with opposing dentition (natural teeth or teeth/implant-supported fixed restorations) and who qualify for placement of Helix Short implants.
Collaborative patient.
Patient with opposing dentition (natural teeth or fixed and/or removable restorations)
Contraindication according to the IFU: This product is contraindicated for patients who show signs of allergy or hypersensitivity to the chemical components of titanium. Implants with a length of 4 mm are contraindicated for single and overdenture rehabilitations, and they are contraindicated for total and multiple restorations when not associated with implants with lengths greater than or equal to 5.5 mm.
Patients with periodontal disease, severe alcohol/tobacco consumption, bruxism, high use of bisphosphonates or proton pump inhibitors (PPI), radiotherapy to the neck and head in the last 3 years, uncontrolled systemic diseases.
Pregnant patient.
Patients with atrophic maxilla and mandible, who need of one or more dental implants with opposing dentition (natural teeth or teeth/implant-supported fixed restorations) and who qualify for placement of Helix Short implants.
Case-only
Prospective
Dental Implant
DeviceDental Implant placement and loading.
Implant success rate
Implant success rate (including survival as one of the criteria for success) of implants at 3 years after implant loading.
Implant survival rate
Implant survival rate
Prosthetic survival and success rates
Prosthetic results
Change in peri-implant bone level
Evaluating bone loss
Soft tissue assessment - Visible Plaque
Visible plaque index will be calculated for each implant site as the percentages of surfaces (mesial, buccal, distal, lingual) presenting visible plaque.
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Neodent
Lead sponsor
Federal University of Uberlandia
Collaborator
UNESP, Câmpus de Araraquara
Collaborator
Faculdade ILAPEO
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
