Prospective Observational Study of Neodent Implantable Devices of GM Line
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Neodent
- 入组人数
- 43
- 试验地点
- 2
- 主要终点
- Implant survival and success rates
研究概览
简要总结
Acqua GM (Grand Morse) Helix implants present an optimized implant design with adapted treatment protocol, allowing for treatment of patients with different bone qualities.
The objective of the study is to prospectively collect clinical data to confirm the long-term safety and clinical performance of Acqua GM Helix implants and GM prosthetic abutments in daily dental practice setting, by means of success and survival rates of these devices.
Devices will be used according to standard routine in daily practice, according to all indications as specified by the manufacturer in the IFU (instructions for use). patients will be followed for 36 months after implant placement.
详细描述
The study protocol was reviewed and approved by an Ethics Committee (CE) in Brazil.
The sample will be prospectively and consecutively selected and will consist of patients who are 18 years of age or older, who are in need of one or more dental implants and who qualify for placement of Neodent GM Helix implants. Informed consent in writing will be obtained from each patient participating in the study prior to any study related procedure.
Neodent Acqua GM Helix implants will be placed under local anesthesia and with adequate bone bed preparation, as recommended by the manufacturer. Multiple implants may be placed in a single subject. Implants will be placed 2mm below the alveolar ridge.
The selection of the prosthetic component and loading protocol (late or immediate) will be conducted according to the need of each subject and to the manufacturer's instructions (IFU). Thus, implant immediate loading may be performed (at the discretion of the surgeon) when primary stability reach at least 32 N.cm and the patient present physiological occlusion.
Data concerning the studied variables will be collected by fulfilling the Case Report Form (CRF), in the following stages: First visit (Screening); T0 - Implant(s) placement; TL - Implant loading; T6, T12, T24 and T36 - 6, 12, 24 and 36 months, respectively, after implant placement. A visit window of more or less one month is eligible for each of the planned intervals.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- 是
入选标准
- •18 years of age or older;
- •Need of one or more dental implants;
- •Qualify for placement of Neodent GM Helix implants.
排除标准
- •As exclusion criteria, solely the device contraindications according to the IFU (instructions for use) will be applied:
- •Signs of allergy or hypersensitivity to the chemical ingredients of the material: titanium alloy;
- •Presence of acute inflammatory or infectious processes in live tissue;
- •Unsuitable bone volume or quality;
- •Serious medical problems (e.g. bone metabolism disorders, blood clotting disorders, unsuitable healing capacity);
- •Insufficient oral hygiene;
- •Incomplete jawbone growth;
- •Patient uncooperative and not motivated;
- •Abuse of drugs or alcohol;
- •Psychosis;
- •Prolonged functional disorders which resist any treatment with medications;
- •Xerostomia;
- •Weakened immunological system;
- •Diseases which require the use of steroids;
- •Uncontrolled endocrinological diseases;
- •Pregnancy.
结局指标
主要结局
Implant survival and success rates
时间窗: 36 months after implant placement
Implant survival will be defined as no loss of the implant at each follow-up. Evaluation of implant success will be assessed based on the criteria proposed by Buser et al. (1990).
次要结局
- Patient Satisfaction: OHIP-14 (Oral Health Impact Profile) questionnaire(6, 12, 24 and 36 months after implant placement)
- Prosthetic survival and success rates(12, 24 and 36 months after implant placement)
- Rate of adverse events related to the implant, prosthesis, surgery and oral health(Implant placement, 6, 12, 24 and 36 months after implant placement)
- Implant survival and success rates(6, 12 and 24 months after implant placement)
- Clinician Satisfaction: VAS (Visual Analogue Scale) questionnaire(Implant placement, 12, 24 and 36 months after implant placement)