Performance of CAD/CAM Milled and 3D-printed Full-arch Implant-supported Provisionals Restorations: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Mechanical behavior of 3D-resin and PMMA-milled materials used as provisional materials in full-arch restorations on implants fabricated by CAD/CAM technology.
研究概览
简要总结
This clinical trial aims to compare the performance of CAD/CAM-milled and 3D-printed full-arch implant-supported provisional restorations in patients at the Advanced Implant Prosthetics Clinic of the Complutense University of Madrid, of both sexes, over 18 years of age, edentulous upper, lower or both, whose treatment plan is at least a fixed implant-supported rehabilitation of the complete arch. The main question it aims to answer is if there are differences in the mechanical behavior and optical properties of the materials used as provisional materials in full-arch restorations on implants fabricated by CAD/CAM technology through machining or 3D printing.
Participants will:
- Receive milled (control material: PMMA; Multilayer PMMA block, HUGE; Shandong Huge Dental Material Corporation) or printed (test material: 3D impression resin; VarseoSmile Temp, Bego Bremer Goldschägerei Wilh. Herbst GmbH & Co. KG, Bremen) and they will be in provisional phase for 3 months doing daily life.
Researchers will compare PMMA (Multilayer PMMA block, HUGE; Shandong Huge Dental Material Corporation) and the printed-resin (3D impression resin; VarseoSmile Temp, Bego Bremer Goldschägerei Wilh. Herbst GmbH & Co. KG, Bremen) to see:
- Mechanical behavior and the absence of complications, fracture of the structure, material jumping or wear, loosening, or detachment.
- Optical properties, initial color, and degradation of the materials used
详细描述
BACKGROUND
Since the discovery of osseointegration by Professor Branemark, dental implants have been introduced into clinical practice and are currently one of the most demanded treatments, being considered the first choice for the rehabilitation of patients with partial or total edentulism. Of all of them, the rehabilitation of the completely edentulous patient is one of the greatest challenges for the professional, since it requires meticulous planning to restore the patient's function and improve esthetics.
In this regard, the introduction of CAD/CAM technology has been a major breakthrough since it allows, as its name suggests, computer assistance in the design and fabrication phase. Its inclusion in the design phase facilitates this process and communication between the clinician and the laboratory with the design file, which could be re-fabricated if there are any complications. P or its use at the manufacturing stage decreases the influence of the laboratory technician's skill and allows the use of new materials. To date, these new materials have been manufactured by milling from a solid disk, the most commonly used materials being polymethylmethacrylate (PMMA) and polyoxymethylene (POM).
In recent years, the industry has focused its efforts on manufacturing by additive technology, by 3D printing, which has different advantages compared to subtractive technology or milling; such as, for example, the greater use of the material or the reduced limitations when manufacturing geometries where milling cannot reach. Gradually, new materials for 3D printing are appearing, with more applications, being already possible the fabrication of models, removable prostheses, gingival masks, unloading splints, and long-lasting temporary prostheses, or surgical guides. Recently, a new material has appeared, whose properties could be comparable to those of the materials used today as temporaries, mainly polymethylmethacrylate (PMMA), which is made by milling from solid blocks.
JUSTIFICATION
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
- Single (Participant)
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
- •Males and females at least 18 years of age.
- •Healthy patients; ASA I or ASA II.
- •Maxillary, mandibular, or both maxillary edentulous patients whose prosthetic treatment plan is a full-arch implant-supported fixed prosthesis.
- •Patients must have voluntarily signed informed consent, be willing and able to attend scheduled follow-up visits, and agree to have coded data collected and analyzed.
排除标准
- •Any contraindications for oral surgical procedures.
- •Smokers classified as "heavy smokers" above 10 cigarettes per day (or more than 1 cigar per day) or smokers of chewing tobacco.
- •Subjects with drug or alcohol abuse.
- •Severe bruxing habits.
- •Conditions or circumstances that, in the opinion of the investigator, would preclude completion of participation in the study or interfere with the analysis of the study results.
结局指标
主要结局
Mechanical behavior of 3D-resin and PMMA-milled materials used as provisional materials in full-arch restorations on implants fabricated by CAD/CAM technology.
时间窗: 2 years
The mechanical behavior will be evaluated on the basis of the occurrence of some mechanical complications. The mechanical complications to be evaluated will be classified by visual inspection in clinical examination as follows: * Appearance of material skips, minor fractures and/or chipping * Appearance of major fractures defined as an appearance of a broken structure that restrain the use of the devise.
Optical properties of 3D-resin and PMMA-milled materials used as provisional materials in full-arch restorations on implants fabricated by CAD/CAM technology.
时间窗: 2 years
The optical properties of the material will be based on the initial color of the material and its degradation from color acquisition using a Vita Easyshade® compact spectrophotometer (Vita, Zahnfabrik - Germany). Five measurements of tooth 1.1 or 4.1 depending on the maxilla will be taken on the day of provisional placement and after three months, the system code of the VITA classical and 3D Master shade guides will also be recorded. In addition, the coordinates of the CIELAB chromatic notation system will be recorded with which the brightness (L), chroma (C) and hue (h) and the differences in brightness (∆L) , chroma differences (∆C) and hue differences (∆H) will be evaluated.
次要结局
未报告次要终点
研究者
Miguel Gómez Polo
Associate Professor of conservative dentistry and prosthodontics
Universidad Complutense de Madrid