A Clinical Evaluation of NobelProceraTM Implant Bar Overdenture in the Mandible or Maxilla on 4 NobelReplaceTM CC Implants
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 77
- 试验地点
- 13
- 主要终点
- MBL,marginal bone level change
研究概览
简要总结
AN OPEN 5-YEAR PROSPECTIVE, CLINICAL MULTI-CENTER STUDY on NobelProcera Implant Bar Titanium with Locator attachment and related Overdenture on 4 NobelReplace implants with conical connection (CC) in the mandible/maxilla.
详细描述
Study centers: 8 centers in 4 countries
Objectives of the study:
Primary Objective:
To evaluate and compare the clinical marginal bone level change (MBL) around the NobelReplaceTM CC implants supporting NobelProceraTM Implant Bar Overdenture (fixed-removable) in the mandible with the clinical marginal bone level change (MBL) of the NobelReplaceTM CC implants supporting NobelProceraTM Implant Bar Overdenture (fixed-removable) in the maxilla for a period of 5 years.
Secondary Objectives:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The subject is at least 18 years of age (or age of consent) and has passed secession of growth
- •The subject is not older than 70 years
- •Obtained informed consent from the subject
- •Edentulous mandible or maxilla providing sufficient bone whereas removable NobelProceraTM Implant Bar Overdenture on four (4) implants is regarded as an appropriate treatment solution
- •The subject has an osseous architecture enough to receive four implants and a sufficient amount of bone for placing in healed or extraction sites implants with a length of at least 10mm
- •The implant site is free from infection and extraction remnants
- •Implants will be placed in healed or extractions sites, defined as a site with 8 weeks of healing following tooth extraction, respectively 6 months after major bone augmentation or soft tissue grafting
- •Good gingival / periodontal / periapical status of opposing teeth/implants
- •The subject fulfills the prerequisite that a harmonic, stable occlusal relationship can be achieved with opposing natural teeth resp. fixed or removable opposing dentition (tooth or implant based
- •The subjects as well as the implant site(s) fulfill the criteria for early loading (6 weeks until 3 months after implant placement)
- •The subject is in such a physical and mental condition that a 5-year follow-up period can be carried out without foreseeable problems
- •The subject is available for the 5-year term of the investigation
- •The subject is compliant with good oral hygiene
排除标准
- •The subject is not able to give her/his informed consent of participating
- •Health conditions, which do not permit the surgical (including anesthesia) or restorative procedure
- •Reason to believe that the treatment might have a negative effect on the subject's overall situation (psychiatric problems), as noted in subject records or in subject history
- •Any disorders in the planned implant area such as previous tumors, chronic bone disease or previous irradiation in the head/neck area
- •Alcohol or drug abuse as noted in subject records or in subject history
- •Smoking of >10 cigarettes/day
- •Uncontrolled diabetes, i.e. a subject with diagnosed diabetes that has a history of neglecting doctor's recommendations regarding treatment, food and alcohol intake
- •Pathologic occlusion, e.g. severe bruxism or other destructive habits
- •Lack of opposing dentition or unstable occlusion
- •Ongoing infections, endodontic or periodontal problems in opposing teeth or implants
- •Subject shows an unacceptable oral hygiene
- •Subject has allergic or adverse reactions to the restorative material.
- •Bone augmentation of more than 3mm vertical height performed less than 3 months prior to planned implant placement.
- •Long-term bis-phosphonate therapy
结局指标
主要结局
MBL,marginal bone level change
时间窗: 6 month, 1, 2, 3, 5 year
To evaluate and compare the clinical marginal bone level change (change MBL)in relation to defined implant reference point and different time points in the maxilla and mandible(between baseline at implant insertion and follow-up time points at 1 month, 6 month, 1 year, 2 year, 3 year and 5 year after implant insertion) of observation.
次要结局
- Gingival Status(6 month, 1, 2, 3, 5 year)
- plaque accumulation(6 month, 1, 2, 3, 5 year)
- Pocket depths(6 month, 1, 2, 3, 5 year)
- CSR implants(6 month, 1, 2, 3, 5 year)
- CSR prosthetics(6 month, 1, 2, 3, 5 year)
- Status of mucosa(6 month, 1, 2, 3, 5 year,)
- Bleeding tendency(6 month, 1, 2, 3, 5 year)