Antibiofilm Activity of Directly Printed Orthodontic Clear Aligners with Incorporated Chitosan Nanoparticles (A Randomized Clinical Trial)
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Antimicrobial properties of chitosan nanoparticles incorporated into directly 3D printed clear orthodontic aligner will be assessed by using antibiofilm assay
研究概览
简要总结
The use of orthodontic appliances and equipment has dramatically increased over the past few decades, mainly due to improvements in materials and manufacturing processes that have paved the way for improved treatments .
The preference for aligner treatment and the increase in its prevalence can be attributed to patient demand for "invisible" treatments and the limitations of conventional fixed orthodontics . Direct 3D printing offers the possibility of creating highly precise clear aligners with soft edges, digitally designed and identically reproduced for an entire set of treatment aligners. These provide a better fit, higher efficacy, and reproducibility .
Clear aligner treatment demonstrated promising results in terms of controlling plaque index, gingival health, and the prevalence of white spot lesions. Nevertheless, grooves, ridges, microcracks, and abrasions on the aligner surface provide a prime environment for bacterial adherence and the development of plaque biofilms. Adding chitosan, a minimally toxic agent with antibacterial properties and the ability to reduce enamel demineralization, to 3D-printed aligner resin materials may decrease the incidence of WSLs . Currently, there is limited research on including nanoparticles in aligners' material for microbe inhibition and, to the best of our knowledge, none of the research has assessed and compared the effect of adding chitosan to an aligner's resin.
详细描述
The use of orthodontic appliances and equipment has dramatically increased over the past few decades, mainly due to improvements in materials and manufacturing processes that have paved the way for improved treatments .
The preference for aligner treatment and the increase in its prevalence can be attributed to patient demand for "invisible" treatments and the limitations of conventional fixed orthodontics. Direct 3D printing offers the possibility of creating highly precise clear aligners with soft edges, digitally designed and identically reproduced for an entire set of treatment aligners. These provide a better fit, higher efficacy, and reproducibility.
Clear aligner treatment demonstrated promising results in terms of controlling plaque index, gingival health, and the prevalence of white spot lesions. Nevertheless, grooves, ridges, microcracks, and abrasions on the aligner surface provide a prime environment for bacterial adherence and the development of plaque biofilms. A combination of mechanical and chemical methods seem to be a successful approach for removing plaque biofilm from aligners whilst preventing pigment adsorption.
Orthodontic appliances change the ecological environment of the oral cavity, resulting in a significant increase in the number of cariogenic bacteria such as Streptococcus mutans (S. mutans). The imbalance in oral homeostasis can lead to enamel demineralization, periodontitis and other bacteria-related adverse effects of orthodontic treatment. According to evidence-based clinical assessments, once enamel demineralization is formed it is difficult to be fully reversed using currently available remineralizing agents. Thus, several antibacterial strategies have been used clinically to prevent enamel demineralization, including antibacterial mouthwashes and toothpastes. However, these conventional interventions are largely dependent on perfect compliance from the patients, which most of the times does not occur.
Chitosan nanoparticles have a wide range of applications and have long been employed with or without other substances and techniques to increase their functionality .
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 28 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects falling in the age group of 18-28 years with mild malocclusion
- •Full permanent dentition except for third molars
- •Plaque score and Bleeding on probing should be less than 10% (O'Leary et al., 1972)
- •No previous history of para-functional habits
排除标准
- •any criteria not mentioned above
研究组 & 干预措施
Control
control directly printed orthodontic clear aligners without chitosan nanoparticles
干预措施: Control (Standard treatment) (Device)
chitosan
Directly printed orthodontic clear aligners with chitosan nanoparticles
干预措施: Chitosan (Device)
结局指标
主要结局
Antimicrobial properties of chitosan nanoparticles incorporated into directly 3D printed clear orthodontic aligner will be assessed by using antibiofilm assay
时间窗: 2 weeks
The main outcome of this study is yo determine the antimicrobial effect of chitosan nanoparticles directly added to 3D printed clear aligners against Streptococcus mutans. This will be conducted by using antibiofilm activity test at baseline, 1 week, and 2 weeks following wearing conventional and chitosan-incorporated clear aligners. From each device retrieved from the patients at these timepoints, a 5mm diameter disc will be cut from the labial aspect of the devices. These discs will be cultured overnight in a broth containing equal number of S. mutans bacteria. After 24 h, the number of vital bacteria and the biomass will be measured to determine the antibiofilm activity of chitosan-incorporated devices vs control.
次要结局
- Self-reported questionnaire about satisfaction of wearing clear aligner (control and experimental)(2 weeks)
研究者
Malak Akram Alhuwaizi
Principal Investigator
University of Baghdad
