Four Versus Six Endosseous Implants to be Used in the Rehabilitation of Totally Edentulous Patient in the Maxilla With Titanium Milled Framework
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Marginal bone resorption in millimeter from the the implant to the bone crest.
研究概览
简要总结
The primary objective of the present study is to evaluate the marginal bone level changes occurring in total edentulous patients treated with six or four implants.
Secondary objective
- overall survival rate
- soft tissue status by assessment of bleeding on probing (BoP) and probing pocket depth (PPD) at baseline and after 1,3,5 years
- prosthetic survival rates including screw or abutment loosening, framework or veneer fractures
详细描述
METHODS/PROCEDURES A randomized controlled multi-center clinical study is designed to determine whether a difference exists between the outcome of treatment when Astra tech implants are placed according to a six or a four implants protocol. The investigation will be performed in four centers: three in Italy affiliated to Institute Franci and one affiliated to the Department of Prosthodontics, Faculty of Odontology, Malmö University. In each center the clinician and the examiner will be the same person. The study protocol will be approved by the Regional Human Review Board of Padova General Hospital.
An investigators' meeting will be arranged prior to the starting with the patients' recruitment. Following a screening examination, subjects who will meet the inclusion criteria, will sign the Informed Consent and will be enrolled in the study. The period of patient enrollment will begin on January 1 2013 and ends December 31 2013.
The patients will be randomized with a method based on the use of sealed opaque envelopes. The cases will be assigned to two different treatment groups:
Group A- four implants (Test) Group B- six implants (Control)
Pre-treatment Patient data, medical history, clinical and radiographic examination will be recorded for each patient. Clinical photographs will be taken in frontal, occlusal and lateral projections.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion criteria:
- •age > 18 years;
- •edentulous maxilla or having hopeless remaining teeth that are intended to be extracted;
- •willingness to comply with all study requirements and to sign the IC;
- •have sufficient amount of bone (8mm or more) in the recipient site to allow implant placement without bone augmentation procedures.
排除标准
- •bone defects associated with severe knife-edge ridges;
- •bone defects resulting from tumor resection;
- •tobacco abuse (> 10 cigarettes/day);
- •severe kidney and liver disease;
- •history of radiotherapy in the head and neck region;
- •chemotherapy for treatment of malignant tumors at the time of the surgical procedure;
- •uncontrolled diabetes;
- •active periodontal disease involving the residual opposite dentition;
- •mucosal disease, such as lichen planus, in the areas to be treated;
- •poor oral hygiene;
- •non-compliant patients;
- •situations judged inconvenient(by the investigator) for the surgical treatment.
结局指标
主要结局
Marginal bone resorption in millimeter from the the implant to the bone crest.
时间窗: 5 year
次要结局
- Fracture of the prosthetic components(5 year)
研究者
Toia Marco
Four versus six endosseous implants to be used in the rehabilitation of totally edentulous patient in the maxilla with titanium milled framework: a randomized, controlled clinical trial.
Institute Franci