A Randomized Controlled, Double-blind Clinical Trial to Evaluate the Clinical Effectiveness of Two Methods of Taking Impressions for an Implant-supported Fixed Prostheses With One-piece Titanium Frameworks in Edentulous Jaws
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 22
- 主要终点
- Grade of framework passive fit
研究概览
简要总结
To compare the accuracy of digital impression and conventional impression for complete-arch implant-supported fixed prosthesis
详细描述
The Intraoral scan is digital optical scan method, that has advantages such as being more comfortable, easy to transfer, and full digital workflow. Conventional impression using silicon rubber and gained stable accuracy of impression. This study aims to compare the accuracy of two methods.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- 否
入选标准
- •Age 18-70 years old (including 18 and 70 years old);
- •The patient's maxilla or mandible cannot be preserved due to missing teeth or remaining teeth proposed for implant-retained restoration;
- •The patient's missing teeth area is available for placement of 4-6 implants;
- •Completion of osseointegration of the patient's implants after implant surgery;
- •The patient has at least 2 mm width of keratinized mucosa in the remaining alveolar ridge;
- •The patient voluntarily participates in the trial and signs an informed consent form
排除标准
- •The patient has a severe gag reflex;
- •The patient has an intermaxillary distance of less than 20 mm in the posterior region;
- •The distance between the two implants is less than 10 mm;
- •Implants fitted with composite abutments with the abutment screw holes penetrating at an angle greater than 60 degrees to the alveolar ridge;
- •Other patients judged by the investigator to be unsuitable for inclusion
结局指标
主要结局
Grade of framework passive fit
时间窗: during the deliver of the framework
The passive fit of the titanium framework is measured with a scoring system. Five aspects are evaluated. whether to pry; Single Screw Probing misfit; All Screws; Probing misfit; Smooth during screwing; X-ray for misfit. For each aspect, 0/1 is scored. the total score is between 0 and 5.
次要结局
未报告次要终点
研究者
Junyu Shi
Associate researcher
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University