Multicentric Prospective Observational Study of Neodent Implantable Devices of Helix Short System
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Neodent
- 入组人数
- 94
- 主要终点
- Implant success rate
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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.
结局指标
主要结局
Implant success rate
时间窗: From the implant loading to the 36-months of follow-up
Implant success rate (including survival as one of the criteria for success) of implants at 3 years after implant loading.
次要结局
- Prosthetic survival and success rates(From the implant loading to 36-months of follow-up)
- Risk factors for Implant Loss(From the enrollment to 36-months of follow-up)
- Soft tissue assessment - Marginal Bleeding Indexes(From the implant loading to 36-months of follow-up)
- Soft tissue assessment - Keratinized gingiva(From the implant loading to 36-months of follow-up)
- Implant survival rate(From the implant loading to the 36-months of follow-up)
- Evaluation of the crown/implant ratio(From the implant loading to 36-months of follow-up)
- Type of load and time for final prosthesis(From the implant placement to 36-months of follow-up)
- Patient satisfaction(From the enrollment to 36-months of follow-up.)
- Clinician satisfaction with all devices used and procedures(From the implant placement to 36-months of follow-up.)
- Soft tissue assessment - Bleeding on probing(From the implant loading to 36-months of follow-up)
- Change in peri-implant bone level(From the implant loading to 36-months of follow-up)
- Soft tissue assessment - Visible Plaque(From the implant loading to 36-months of follow-up)
- Adverse events and residual risks related to the implant, prosthetic component, and prosthesis.(From the enrollment to 36-months of follow-up.)