In Vivo Clinical Investigation of the Safety and Performance of Dental Implants TBR® Bone Level
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 138
- 试验地点
- 1
- 主要终点
- the success rate of tissue integration of the implant
研究概览
简要总结
Partial or total edentulousness has a significant impact on quality of life both functionally and aesthetically.
TBR® Bone Level Implants allow the patient to prevent bone resorption and maintain facial tissue and musculature support. At the functional level, the patient who benefits from implant treatment regains normal masticatory function with all the benefits on the quality of life that this can bring him.
Due to the osseointegration of the implant and the biocompatibility of the materials used, the implant treatment remains effective in the long term and makes it possible to maintain the aesthetics of the smile.
详细描述
Many adults have one or more missing teeth. The negative consequences of partial or total edentulousness are numerous in the orofacial sphere:
- Edentulousness causes a strong aesthetic deficit due to the lack of support of facial tissues and musculature;
- Edentulousness generates a functional deficit that can have significant repercussions on the nutritional status of the affected subject;
- Edentulousness is accompanied by bone resorption of the jawbones which is inevitable in the absence of implant treatment;
- In addition, the resulting feelings of discomfort and fragility are experienced as a real psychological handicap by the patient, partially or totally edentulous, which can then have significant repercussions on his social life.
TBR® Bone Level implants are intended for placement in the maxillary or mandibular arch in partially or completely edentulous patients for prosthetic restoration in the following cases:
- Single edentulousness,
- Intercalary edentulousness,
- Terminal edentulousness,
- Total edentulousness.
The following clinical conditions must be observed before placing a dental implant:
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient 18 years of age or older
- •Patient who has completed bone growth
- •Patient informed and willing to participate in the study
- •Partially or totally toothless patient who will be implanted with the TBR® Bone Level implant(s) for the prospective cohort
- •Patient implanted with the TBR® Bone Level implant(s) before June 2011 for the retrospective cohort
排除标准
- •Pregnant or lactating women
- •Patient with bone disease of the head and neck region
- •Patient refusing to participate in the study
- •Patient with at least one contraindication to implantation
- •Patient on osteoporosis treatment with Biphosphonates or Denosumab.
结局指标
主要结局
the success rate of tissue integration of the implant
时间窗: 15 years after implantation
Integration of the implant 15 years after implantation
次要结局
- Absence of inflammation (visual) and infection (radiographic)(5 years after implantation)
- Change of the quality of life of patients following the recovery of a complete dentition with the OHIP- 14 score (Oral Health Impact Profile)(5 years after implantation)
- Measuring chewing function with occlusal assessment(5 years after implantation)
- Complication rate taking into account pain, local tenderness, infection, allergy, mobility of the implant, fracture(5 years after implantation)
- Radiographic analysis of the osseointegration of the implant(5 years after implantation)