Comparison of the Accuracy of Digital and Conventional Impression in Edentulous Arch
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Vision and tactile score for evaluating passive fit of metal framework
研究概览
简要总结
The goal of this clinical trial is to determine whether the accuracy of digital impressions is comparable to conventional impressions. It will also learn about the clinical effect of different method. The main questions it aims to answer are: Does drug ABC lower the number of times participants need to use a rescue inhaler? What medical problems do participants have when taking drug ABC? Researchers will compare digital impression to conventional impression to see if the accuracy of the digital method.
Participants will:
Take an impression with one of the methods Visit the clinic a total of 6 times for checkups and tests
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
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 30-80 years (inclusive) with no gender restriction.
- •Patients who will receive a full-arch one-piece implant-supported fixed
- •permanent restoration in the maxilla or mandible.
- •Patients with osseointegrated implants after surgery.
- •Patients voluntarily participate in the trial and sign the informed consent form.
排除标准
- •Patients with insufficient interarch space in the posterior region for impression coping placement.
- •Patients with minimal inter-implant distance may prevent impression coping installation.
- •Patients with temporomandibular joint (TMJ) disorders are unable to maintain prolonged mouth opening for impression procedures.
- •Other conditions deemed ineligible for inclusion by the investigator.
研究组 & 干预措施
digital impression
干预措施: digital impression (Procedure)
conventional impression
干预措施: conventional impression (Procedure)
结局指标
主要结局
Vision and tactile score for evaluating passive fit of metal framework
时间窗: Periprocedural: At the time of the titanium framework try-in: the try-in of the framework to the patient is before final delivery. (The delivery of the final prosthesis is the baseline)
Five aspects are evaluated, each aspect is scored as 0 or1. The score ranges from 0 to 5 points. 1、Framework rocking upon seating？2、 Gap assessment with single screw test. The method utilized an explorer with an approximately Ø60-µm tip to evaluate the margins of the metal framework.3、 Gap assessment with all screws tightened. 4、Are the screws threading smoothly? 5、Radiographic assessment of framework fit (check for gaps).
次要结局
未报告次要终点
研究者
Junyu Shi
associate professor
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University