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

Neodent

Status: Not yet enrolling

Conditions: Atrophy of Edentulous Alveolar Ridge; Atrophy of Edentulous Mandibular Alveolar Ridge; Dental Implant; Edentulism; Atrophy of Edentulous Maxillary Alveolar Ridge

Treatments: Device: Dental Implant

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT07119151

CS.O.014

Details and patient eligibility

About

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.

Enrollment: 94 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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)

Exclusion criteria

• 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

94 participants in 1 patient group

Treatment

Description:

Patients with maxillary and mandible atrophy in need of one or more dental implants and who were evaluated as suitable for the installation of Helix Short implants.

Treatment:

Device: Dental Implant