Precision of Different Scanbodies Used for Direct Digital Impression in Fabrication of Implant Supported Fixed Prosthesis: A Methodologic Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Clinical fit
研究概览
简要总结
The goal of this clinical trials to evaluate precision of different scanbodies in same participant group. The main guestion it aim to answer is:
- Are the precision of the three different scanbodies used in direct digitalization the same for the produce of implant-supported prostheses?
Participants are healty and have short edentulous span in posterior region that will receive implant-supported prostheses.
详细描述
Twenty-five patients receiving two implant supported restorations in treatment of short-span partial edentulism were enrolled into the study. Three different scanbodies, original, non-original and generic, were employed for direct digitalization technique. Full contour PMMA restorations were CAD/CAM fabricated from each digital record, and were evaluated in terms of implant fit, axial- and occlusal-contact. Additionally, patient's impressions for digitalization and delivery procedures were recorded using a visual analog scale. Scanbody scan recordings were subjected to reverse engineering for analytical evaluation of 3D virtual implant positioning.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
盲法说明
Scan post information used for direct digitalization was not shared with the patient during the procedure.
The investigator, who performed the statistical analysis, did not learn the scan post, in which the primary and secondary data were collected, until all evaluations were completed.
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
- •Be willing to voluntarily participate in the study after reading the informed consent form.
- •Adult patient over 18 years of age who has completed growth and development
- •Partial edentulism in the functional region for a two-implant-supported restoration with two or three occlusal members
- •Having a fixed dentition in the opposing arch
- •The occlusal relationship between the jaws does not require vertical and horizontal prosthetic treatment.
- •Having bone-level implants placed with "straightforward" surgery according to the SAC classification system [248] and without advanced surgical technique
排除标准
- •Not voluntarily agreeing to participate in the study after reading the informed consent form
- •Having one or more of the conditions for which implant treatment is strictly contraindicated (patients who have received radiation therapy, bone cancer, metabolic disorders)
- •Having systemic (steroid therapy, uncontrolled diabetes, immunological disorders, pregnancy) risk factors for implant treatment
- •Having local (periodontal discomfort, bruxism, poor oral hygiene) risk factors for implant treatment
结局指标
主要结局
Clinical fit
时间窗: 1 year
Compatibility between the manufactured restorations and implant 0: incompatible 1: compatible
interface contact
时间窗: 1 year
Restoration interface contacts with the adjacent teeth. II. Interface Contacts: 1. Perfect: The floss is inserted into the interdental space only under pressure, 2. Acceptable (1): The contact is slightly tight but the floss is placed under pressure, 3. Acceptable (2): The contact is slightly weak, the floss is placed in one stroke without applying pressure, 4. Correction required: Contact is poor and 100 μm metal sheet passes easily.
occlusal contact
时间窗: 1 year
Restoration occlusal contact with the opposite teeth. I.Occlusal Contacts: 1. Perfect: No need for occlusal contact adjustment, 2. Acceptable: Minor occlusal contact adjustment is needed, 3. Correction needed: Major occlusal contact adjustment is needed.
Analytical measurement of 3D implant positions
时间窗: 1 year
Analytical outcomes were obtained from scan bodies using reverse engineering software used to calculate 3D implant positions.
次要结局
- Visual analog scale(1 year)
研究者
Kıvanç Akça
Prof. Dr.
Hacettepe University