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

Обзор

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.

Вмешательства

• Устройство Dental Implant
  Dental Implant placement and loading.

Первичные конечные точки

• Implant success rate [Срок оценки: From the implant loading to the 36-months of follow-up]

Вторичные конечные точки (12)

• Implant survival rate [Срок оценки: From the implant loading to the 36-months of follow-up]
• Prosthetic survival and success rates [Срок оценки: From the implant loading to 36-months of follow-up]
• Change in peri-implant bone level [Срок оценки: From the implant loading to 36-months of follow-up]
• Soft tissue assessment - Visible Plaque [Срок оценки: From the implant loading to 36-months of follow-up]
• Evaluation of the crown/implant ratio [Срок оценки: From the implant loading to 36-months of follow-up]
• Risk factors for Implant Loss [Срок оценки: From the enrollment to 36-months of follow-up]
• Type of load and time for final prosthesis [Срок оценки: From the implant placement to 36-months of follow-up]
• Patient satisfaction [Срок оценки: From the enrollment to 36-months of follow-up.]
• Clinician satisfaction with all devices used and procedures [Срок оценки: From the implant placement to 36-months of follow-up.]
• Adverse events and residual risks related to the implant, prosthetic component, and prosthesis. [Срок оценки: From the enrollment to 36-months of follow-up.]
• Soft tissue assessment - Marginal Bleeding Indexes [Срок оценки: From the implant loading to 36-months of follow-up]
• Soft tissue assessment - Bleeding on probing [Срок оценки: From the implant loading to 36-months of follow-up]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Только случаи

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07119151 · CS.O.014

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗