Clinical Evaluation of Digitally Fabricated 3D-printed Band and Loop Space Maintainers Versus Conventional Band and Loop Space Maintainer : a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 主要终点
- Survival rate
研究概览
简要总结
This study aims to compare the clinical evaluation and patients' satisfaction of space maintainers produced by digital workflow using the 3D-printing method (3D-SMs) versus conventional band and loop space maintainers (C-SMs) produced by traditional methods.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
double blinded
入排标准
- 年龄范围
- 4 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Lower first permanent molar in active state of eruption
- •Patient and parent showing cooperation and compliance.
- •Medically free children.
- •According to space analysis available space is less than or equal to needed space
- •Primary molar loss in the last 1 week due to caries, infection, and resorption (to eliminate possible space loss)
- •Caries free, non-restored buccal surfaces of the mandibular second primary molars and deciduous canines.
排除标准
- •Children with previous allergies to stainless steel.
- •There was less than one year left for the permanent tooth to erupt (to prevent possible abutment toot loss)
- •The patient's oral hygiene is not sufficient and has periodontal problems (to accurately assess the periodontal effects)
研究组 & 干预措施
Conventional band and loop space maintainer
Impressions will be taken from the patients with sterilized plastic pedodontic impression trays and alginate under standard conditions by the same researcher. Alginate will be mixed in accordance with the manufacturer's instructions. After the impressions, plaster study casts will be produced and sent to the laboratory. Conventional SMs will be produced by soldering the 0.7-mm bent orthodonic wires (Dentaurum, Germany) onto previously selected prefabricated molar bands. Prefabricated molar bands (Dentaurum, Germany) in the patient's mouth will be chosen by the physician and then sent to the laboratory with the casts.
All SMs will be cemented by the same investigator under standard conditions using a glass-ionomer luting cement (Nova Glass-L, Imicryl, Konya, Turkey).
干预措施: Conventional space maintainer (Other)
3D printed space maintainer
Patients in this group will be scanned under standard conditions with Medit i500 (Medit Corp. Seoul, South Korea). The scanned data of the patients will be sent to the laboratory via email in Standard Triangle Language (STL) file format.The design of SMs will be carried out on the DentalCAD 2.2 Valletta (Exocad GmbH, Darmstadt, Germany) program to mimic the conventional space maintainer, and the production will be made by the 3D Selective laser melting (SLM Solutions, Germany) method using titanium-based metal powder (Ti64 Gd23; LPW Technology Ltd., Cheshire, UK). The production of 3D-SMs will start in accordance with the C-SM design in many points, such as the fit of the part surrounding the abutment tooth, thickness, and the position of the loop of 3D-SM.
All SMs will be cemented by the same investigator under standard conditions using a glass-ionomer luting cement (Nova Glass-L, Imicryl, Konya, Turkey).
干预措施: 3D printed space maintainer (Other)
结局指标
主要结局
Survival rate
时间窗: 1 year
Decementation, debonding, solder breakage, loop breakage, band breakage, and abutment tooth fracture will be evaluated clinically for both space maintainers
次要结局
- Gingival health of the abutment(0,6,12 months)
- Plaque accumulation on the abutment tooth(0,6,12 months)
- Patients' satisfaction about the impression technique(Immediately after the im- pression/scanning)
研究者
Aya Alaa Abdelaziz Elsayed
Assistant lecturer
Cairo University