Implant Retained Rehabilitation With Surgical and Prosthetic Digital Workflow: A Randomized Clinical Trial
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
- 18
- 试验地点
- 2
- 主要终点
- Amount of peri-implant bone level change
研究概览
简要总结
The aim of this study is to prospectively collect clinical data to confirm the safety and clinical performance of Neodent Titanium Base Abutment and Pro PEEK Abutment in daily dental practice setting, by means of a randomized clinical study of prosthetic rehabilitation using these devices.
A total of 48 healed implant sites (at least 4 months post-extraction) shall be included during the sample enrollment (24 patients), which will be randomly divided into two groups, so that each patient receives one implant from each group (removal and non-removal of the abutment placed at the time of surgery).
Patients will be followed for 24 months after implant loading. It is expected that there is no difference in peri-implant bone level change between the two treatment groups.
详细描述
The study protocol was reviewed and approved by an Ethics Committee (EC) in Brazil.
Sample size was calculated based on an alpha level of 5% and beta of 20% to detect a mean intergroup difference of 0.2mm, with a standard deviation of 0.2mm, in peri-implant bone level change 24 months after implant loading. Sample size calculation showed that a sample of 17 implants is needed for each group. With rate of 2 implants per patient and a "worst-case" drop-out rate of 20%, a sample size of 24 patients resulting in an estimated number of 24 implants, in each group, is thought to be sufficient to allow statistical analysis of clinical outcome data.
A total of 48 healed implant sites (at least 4 months post-extraction) shall be prospectively and consecutively selected during the sample enrollment (24 patients).
Data concerning the studied variables will be collected in the following stages: Screening (First visit); TP - Implant placement; TT - Impressions for temporary prosthesis confection (2 ± 1 days prior to T0); T0 - Implant Loading (temporary prosthesis placement - 21 ± 1 days after implant placement); TF - Impressions for final prosthesis confection (10 ± 1 business days prior to T6); T2 - Final prosthesis placement (2 months ± 1 week after loading); T12 and T24 - 12 and 24 months ± 1 month, respectively, after loading.
In both study groups, 4.0x10 mm Neodent GM Helix Implants will be placed 2mm subcrestally (in relation to the buccal bone plate) in the posterior region of the maxilla, under local anesthesia and with adequate bone bed preparation, as recommended by the manufacturer, using the guided surgery technique. Two implants (one of each group) will be placed in the same individual, to be restored by single prostheses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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;
- •2 upper posterior teeth missing, with adjacent natural tooth;
- •Healed implant sites (at least 4 months post-extraction);
- •Qualify for placement of 4.0x10 mm Neodent GM Helix implants;
- •Adequate bone height to allow the 2mm subcrestal placement of a 10-mm-long implant.
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 materials: titanium, titanium alloy (Ti6Al4V-ELI) or PEEK (Polyetheretherketone);
- •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
Amount of peri-implant bone level change
时间窗: 2, 6, 12 and 24 months after implant loading
Peri-implant bone level will be measured on the periapical radiographs obtained as the distance between the coronal margin of the implant shoulder and the most coronal point of the peri-implant bone, on the mesial and distal surfaces of each implant. The horizontal measurement of the remodeling will be done, when there is no bone contact in the cervical part of the implant. This measurement will be performed from the superior site of the bone crest to the lateral edge of the implant, perpendicular to the long axis of the implant.
次要结局
- Implant survival(2, 6, 12 and 24 months after implant loading)
- Implant success(2, 6, 12 and 24 months after implant loading)
- Prosthetic survival(2, 6, 12 and 24 months after implant loading)