NCT05375045招募中不适用
Real-life Evaluation of the Safety and Performance of EUROTEKNIKA Dental Implants
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Euroteknika
- 入组人数
- 868
- 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
Real-life evaluation of the safety and performance of EUROTEKNIKA dental implants
详细描述
Many adults have one or more missing teeth. The negative consequences of partial or total edentulousness are numerous at the level of the orofacial sphere :
- Edentulism generates a strong aesthetic deficit due to the lack of support of the tissues and the facial musculature;
- Edentulism causes a functional deficit that can have significant repercussions on the nutritional status of the affected subject;
- Edentulism is accompanied by bone resorption of the jaws which is unavoidable 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.
EUROTEKNIKA dental implants are intended to be used for the replacement of a dental root in order to support a fixed or mobile prosthesis and thus restore masticatory function. EUROTEKNIKA dental implants are made of titanium or titanium alloy for surgical implants in accordance with ISO5832-2 and -3 standards.
EUROTEKNIKA dental implants are intended for use in cases of single, partial or complete edentulism on the maxillary and/or mandibular arch:
- Single tooth loss,
- Intercalary toothlessness,
- Terminal toothlessness,
- Total edentulism.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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 aged 18 or over
- •Patient who has completed bone growth
- •Patient informed and agreeing to participate in the study
- •Partially or totally edentulous patient who will be implanted with the EUROTEKNIKA dental implant (for the prospective cohort)
- •Patient to benefit from the placement of an implant for the creation of a single crown (for the prospective cohort)
- •Patient implanted with the EUROTEKNIKA dental implant before 2017 (for the retrospective cohort)
- •Patient having benefited from the placement of an implant for the creation of a single crown (for the retrospective cohort)
排除标准
- •Pregnant or breastfeeding women (for the prospective cohort)
- •Patient with bone disease in the cervico-facial region
- •Patient refusing to participate in the study
- •Patient with at least one contraindication to implantation (for the prospective cohort)
- •Patient to benefit from the placement of an implant with immediate or early loading (for the prospective cohort)
- •Patient to benefit from the placement of an implant for the support of the bridge, piles, attachment (for the prospective cohort)
- •Patient having benefited from the placement of an implant with immediate or early loading (for the retrospective cohort)
- •Patient having benefited from the placement of an implant for the support of the bridge, piles, attachment (for the retrospective cohort)
结局指标
主要结局
The success rate of tissue integration of the implant
时间窗: 5 years after implantation
Integration of the implant 5 years after implantation
次要结局
- assessment of the quality of life of patients following the recovery of full dentition with the GOHAI score (General Oral Health Assessment Index)(5 years after implantation)
- Complication rate taking into account pain, local tenderness, infection, mobility of the implant, fracture(5 years after implantation)
- assessment of the osseointegration of the implant(5 years after implantation)
- measuring chewing function after prosthesis placement(5 years after implantation)
- Rate of inflammation (visual)(5 years after implantation)
- Assessment of the evolution of the péri-implant tissues(5 years after implantation)
- Rate of infection (x-ray)(5 years after implantation)
研究者
研究点 (1)
Loading locations...
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