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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorNeodent

About this trial

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.

Eligibility criteria

Qualifiers

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)

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Dental Implant

Treatment groups

94 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators

Neodent

Lead sponsor

Federal University of Uberlandia

Collaborator

UNESP, Câmpus de Araraquara

Collaborator

Faculdade ILAPEO

Collaborator