Prospective Study of Neodent® Implantable Devices of Zirconia System
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Neodent
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Implant survival rate
研究概览
简要总结
The Neodent® Zirconia Implant is designed for the treatment of oral endosteal implantation for the functional and aesthetic rehabilitation, allowing for treatment of patients with different bone qualities.
The objective of the study is to assess the success and survival rates of implantable devices of the Zirconia System, in order to confirm the long-term safety and clinical performance of implants and abutments of the Zirconia System in daily dental practice setting.
Devices will be used according to standard routine in daily practice, according to manufacturer indications in the IFU. 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 and who qualify for single dental implants placement in the posterior maxilla region with Neodent® Zirconia. Informed consent in writing will be obtained from each patient participating in the study prior to any study related procedure.
As this study will be analyzed descriptively, sample size calculation was not performed. To generate reliable results, a total number of 30 implants was assumed to be sufficient. Estimating a rate of 1 implant per patient and a drop-out rate of 15%, a sample size of 36 patients resulting in an estimated number of 36 implants is thought to be sufficient to allow for a descriptive analysis of clinical outcome data up to 36 months after implant placement.
Treatment provided to the subjects will be the responsibility of an appropriately qualified dental practitioner to provide the relevant patient care under clinical study conditions. Zirconia Implants will be placed under local anesthesia and with adequate bone bed preparation in posterior maxilla region. More than one implant can be placed in the same patient, as long as the subject presents natural teeth adjacent to the implant site.
Immediately after implant placement, the final placement torque will be registered. The immediate loading will be applied within 48 hours with the insertion of a provisional prosthesis made from intraoral scanning or scanning of dental casts obtained by conventional impression. The insertion torque shall reach at least 35 N.cm and the subject must have physiologic occlusion to immediate loading. If the patient does not reach the minimum torque (35 N.cm), the patient will be followed until the study end but will not be considered to final statistic or, a different implant line would be placed and the study termination form will be filled. The principal investigator will choose how to procedure in this situation. The selection of the prosthetic component shall be conducted according to the need of each subject and to the manufacturer's instructions (IFU). The final prosthesis will be placed 2 months after implant loading.
Data concerning the studied variables will be collected following the procedures and assessments plan by fulfilling the Case Report Form (CRF), in the following stages: screening (First visit); TP - Implant(s) placement and impression/scanning for temporary prosthesis preparation; T0 - Implant(s) loading (up to 48h after placement); TF - Final prosthesis placement (2 months ± 1 week after loading); T6, T12, T24, T36 - 6, 12, 24 e 36 ± 1 month, respectively, after loading.
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;
- •Maxillary posterior teeth missing, with adjacent natural teeth;
- •Patient who are in need of oral rehabilitation with dental implants and single prostheses and qualify for placement of Zirconia Implants.
排除标准
- •Subjects under 18 years of age, pregnant or breastfeeding women. And patients that present the device contraindications according to the IFU (instructions for use):
- •Signs of allergy or hypersensitivity to the chemical ingredients of the material: Zirconia (Y-ZTP), Zirconium dioxide (ZrO2), Yttrium oxide (Y2O3), Hafnium dioxide (HfO2), Aluminum oxide (Al2O3);
- •Acute inflammatory or infectious processes;
- •Unsuitable bone volume or quality;
- •Serious medical problems (e.g. bone metabolism disorders, blood clotting disorders, unsuitable healing capacity);
- •Incomplete jawbone growth;
- •Patient uncooperative and not motivated;
- •Hypochondria;
- •Alcoholism;
- •Psychosis;
- •Prolonged functional disorders which resist any treatment with medications;
- •Xerostomia;
- •Weakened immunological system;
- •Diseases which require regular use of steroids;
- •Uncontrolled endocrine diseases;
- •Insufficient oral hygiene;
- •Pregnancy;
结局指标
主要结局
Implant survival rate
时间窗: 36 months after implant placement
Implant survival will be defined as no loss of the implant.
Implant success rate
时间窗: 36 months after implant placement
Evaluation of implant success will be assessed based on the criteria proposed by Buser et al. (1990).
次要结局
- Implant survival rate(6 months after implant placement)
- Prosthetic survival rate(36 months after implant placement)
- Implant success rate(6 months after implant placement)
- Prosthetic success rate(36 months after implant placement)
- Patient satisfaction: questionnaire(At screening visit, after the temporary prosthesis period and 6, 12, 24 and 36 months after implant placement)
- Rate of adverse events related to the implant, prosthesis, surgery and oral health(At implant placement, implant loading, final prosthesis placement and 6, 12, 24 and 36 months after implant placement)
- Clinician satisfaction: questionnaire(At implant placement, implant loading and 6, 12, 24 and 36 months after implant placement)