A Randomized, Controlled, Double Blind, Clinical Trial to Treat Patients With Edentulous Mandibles With Two Straumann 3.3mm Ø Bone Level Implants by Comparing Two Different Implant Alloys in Split Mouth Design.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 91
- 试验地点
- 15
- 主要终点
- Change in Crestal Bone Level Between Surgery and 12 Months, to Compare Between the Titan Zircon Implant and the Titan Grade IV Implant.
研究概览
简要总结
The purpose of this study is to assess the change of crestal bone level at the Titanium Zirconium (TiZr) compared to Titanium (grade IV) implant between surgery and 6, 12, 24, and 36 month post surgery.
详细描述
This is a clinical trial to compare crestal bone level changes, soft tissue parameters, implant success and survival between small diameter implants in edentulous mandibles restored with removable overdentures.
An initial patient evaluation will be conducted to determine wether a patient meets the study inclusion and exclusion criteria.
The edentulous subjects will undergo surgery for placement of two dental implants, the test and control implant. The implants will be placed in the intraforaminal region.
A gingival former will be inserted in the implant after implant placement to ensures a transmucosal healing. After 6 to 8 weeks the healing abutments will be retrieved and the locator abutments will be connected to the implant.
The removable prosthesis will be prepared and connected to the implants two weeks later.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Subjects must have voluntarily signed the informed consent form
- •Males and females must be 18 years of age.
- •Patients must present with an edentulous mandible at the time of surgery.
- •The last tooth or teeth in the mandible must have been extracted or lost more than 8 weeks before the date of first stage surgery.
- •The opposing dentition must be edentulous with a denture (implant borne or conventional) or natural or restored teeth
- •Adequate bone height of at least 9 mm above vital structures (because the minimal available implant lengths is 8mm) in the intraforaminal region. Available bone width should be in such way that 3.3 mm implants can be placed without the use of concurrent bone augmentation techniques. Harvested bone from the drilling sites may be used to cover minor dehiscence defects.
- •Patients must be committed to participate in the study for three years of follow-up examinations
排除标准
- •Medical conditions requiring prolonged use of steroids
- •History of leukocyte dysfunction and deficiencies
- •Patients with sever hemophilia
- •History of head and neck radiation or chemotherapy
- •Patients with history of renal failure
- •The application of bisphosphonate medication
- •History of uncontrolled endocrine disorders
- •Physical handicaps that would interfere with the ability to perform adequate oral hygiene
- •Use of any investigational drug or device within the 30-day period immediately prior to implant surgery on study day
- •Alcoholism or drug abuse
- •Patients with known infection of HIV
- •Patients who smoke more than 10 cigarettes per day or cigar equivalents, or who chew tobacco (not greater than 10 cigarette equivalents)
- •Fertile females with no adequate method of birth control (contraceptive pill, barrier method, etc.)
- •Conditions or circumstances, in the opinion of the investigator, which would prevent completion of study participation or interfere with analysis of study results, such as history of non-compliance, unreliability.
结局指标
主要结局
Change in Crestal Bone Level Between Surgery and 12 Months, to Compare Between the Titan Zircon Implant and the Titan Grade IV Implant.
时间窗: 12 months
Panoramic radiographs with standardized setting were taken at the implant surgery and after 12 month. Digital images were analyzed using Image J 1.33 open software and film-based images were digitalized via a video camera, light box and an image analysis program, as described by Braegger (1998; Braegger at al. 2004). All images were analyzed by an independent investigator who was blind to the implant material. The implant length was used as a reference measurement, and the implant chamfer 0.2 mm above the implant shoulder was used as the reference line for the bone-level measurement. Bone level was, therefore, defined as the distance from the reference point to the first bone-to-implant contact; mesial and distal bone-level changes in this region were considered as remodeling. Mesial and distal measurements were recorded and the mean of the two values was used.
次要结局
- Soft Tissue and Safety Assessments(after 12, 24, and 36 month)
- Success and Survival Rate of Both Study Implants Titanium Grade IV and Titanium Zirconium) According to Definition by Buser et al. 1990(at 12, 24 and 36 months post surgery)