Comparison Between Conventional and Digital Workflow in Fixed Dental Prosthetic Rehabilitations: a Randomized Clinical Trial Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Patient satisfaction degree
研究概览
简要总结
The aim of this comparative RCT is to evaluate the differences between the entire digital, the combined digital-analogic and the entire analogic workflows of implant-supported and teeth-supported prostheses. It is a three-arms comparative study. The 60 patients are divided into three groups:
- fully digital workflow
- combined digital and conventional workflow
- fully conventional workflow For each patients were evaluated the interproximal (IC) and occlusal contact (OC) and impression time (IT) and the patient satisfaction through a VAS scale.
The null hypothesis is that are no differences between the three groups for each parameter.
详细描述
This comparative RCT aims to evaluate the differences between the entire digital, the combined digital-analogic, and the entire analogic workflows of implant-supported and teeth-supported prostheses. It is a three-arms comparative study to better focus on the reliability of digital techniques.
Inclusion criteria were good oral health, absence of parafunction, no dental caries or presence of periodontitis, and healthy general conditions.
Exclusion criteria were bad oral health, parafunctions, dental caries or periodontitis, and general health comorbidities that don't allow surgical treatment.
The 60 patients are divided into three groups:
- fully digital workflow: each patient in this group was treated with an exclusively digital workflow, from digital planning of the surgical phase to digital impression and digital manufacturing of prosthetic crowns.
- combined digital and conventional workflow: each patient of this group was subjected to digital planning, and then, the impressions were taken with traditional analogical materials, so the plaster model was converted into a digital model, and there finally was performed a digital manufacturing of prosthetic crown.
- entirely conventional workflow: each patient was treated with an analogical technique. No digital phase was performed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •good oral health
- •good general health conditions
- •no contraindication to oral surgery and fixed prosthesis
- •patients who completed the 6 months follow-up
排除标准
- •bad oral health
- •bad general health conditions (with multi-drug therapy)
- •periodontitis or dental caries susceptibly
- •parafunctions presence
- •TMJ disorders
- •didn't accept the informed consent / treatment planning
结局指标
主要结局
Patient satisfaction degree
时间窗: 2 weeks after definitive prosthesis delivery
Patient satisfaction through a VAS scale. The patients is asked to make a mark in an unnumbered line ranging from 0 to 5 where 0 represents maximum comfort and 5 represents a very bad experience. The scale is 5 cm long so the clinician next measures the distance (in cm) from 0 to where the mark was placed by the patient.
Entity of occlusal contact
时间窗: 2 weeks after definitive prosthesis delivery
The entity of contact between prosthetic crown and antagonist teeth was evaluated with a dichromatic articulating paper in order to identify any static and dynamic alterations in occlusal contacts that must be corrected. The clinician gives a score from 0 to 3 where 0 is the absence of contact between crown and antagonists, 1 is a correct contact between them that needs no corrections, 2 there is a slight altered contact that requires minor corrections and 3 there is an altered contact between the prosthetic crown and their antagonists which requires major corrections.
Impression time
时间窗: 2 weeks after definitive prosthesis delivery
Length of time useful to take impression expressed in seconds
Entity of interproximal contact
时间窗: 2 weeks after definitive prosthesis delivery
Precision of interproximal contact between prosthetic crown and adjacent teeth. It was measured by the clinician evaluating the resistance to the sliding of waxed dental floss. The clinician gives to the interproximal contact a score from 0 to 4, where 0 is considered as an absence of resistance (open space between crown and adjacent teeth) and 4 is the total impediment to the floss slide (the crown and the adjacent teeth are too close to have a correct interproximal contact)
次要结局
未报告次要终点
研究者
Massimo Corsalini
Prof
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari