跳至主要内容
临床试验/NCT06823310
NCT06823310进行中(未招募)不适用

Antibiofilm Activity of Directly Printed Orthodontic Clear Aligners with Incorporated Chitosan Nanoparticles (A Randomized Clinical Trial)

University of Baghdad1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2025年1月25日最近更新:
适应症
干预措施

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

Other

control directly printed orthodontic clear aligners without chitosan nanoparticles

干预措施: Control (Standard treatment) (Device)

chitosan

Experimental

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Malak Akram Alhuwaizi

Principal Investigator

University of Baghdad

研究点 (1)

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