Development of Biofunctional 3D Printed Orthodontic Aligners Enriched With Remineralizing and Anti-microbial Agents
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Antimicrobial Activity of Modified 3D-Printed Aligner Resin
研究概览
简要总结
Clear orthodontic aligners are widely used due to their esthetics and patient comfort; however, prolonged wear may promote biofilm accumulation and enamel demineralization. This laboratory-based (in vitro) study aims to develop and evaluate a novel directly 3D-printed orthodontic aligner resin modified with antimicrobial and remineralizing agents.
The study will investigate the incorporation of dimethylaminohexadecyl methacrylate (DMAHDM) as an antibacterial agent and amorphous calcium phosphate (ACP) as a remineralizing component into a 3D-printed aligner resin. Modified and unmodified resin specimens will be fabricated and assessed for antimicrobial activity, ion release, and enamel remineralization potential using extracted human teeth.
In addition, the mechanical and physical properties of the experimental aligner materials, including shape memory behavior, deflection, tensile strength, translucency, and water sorption, will be evaluated to ensure clinical suitability.
This study does not involve human participants and is conducted entirely in vitro. The findings are expected to contribute to the development of biofunctional orthodontic aligners that actively inhibit bacterial growth and support enamel health without compromising material performance
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Extracted human teeth obtained for reasons unrelated to this study (e.g., orthodontic or periodontal indications).
- •Teeth collected after obtaining ethical approval from the Research Ethics Committee.
- •Teeth free from visible cracks, fractures, restorations, or developmental defects.
排除标准
- •- Teeth with caries, restorations, cracks, fractures, or structural defects.
- •Teeth extracted due to pathological conditions affecting enamel or dentin integrity.
- •Teeth with unknown extraction history
研究组 & 干预措施
control group
Directly 3D-printed orthodontic aligner resin
干预措施: Modified 3D-Printed Orthodontic Aligner Resin (Other)
DMAHDM group
Directly 3D-printed orthodontic aligner resin with incorporation of dimethylaminohexadecyl methacrylate (DMAHDM)
干预措施: Modified 3D-Printed Orthodontic Aligner Resin (Other)
ACP group
Directly 3D-printed orthodontic aligner resin with incorporation of Amorphous calcium phosphate (ACP)
干预措施: Modified 3D-Printed Orthodontic Aligner Resin (Other)
DMAHDM + ACP group
Directly 3D-printed orthodontic aligner resin with incorporation both DMAHDM and ACP
干预措施: Modified 3D-Printed Orthodontic Aligner Resin (Other)
结局指标
主要结局
Antimicrobial Activity of Modified 3D-Printed Aligner Resin
时间窗: day 1
Evaluation of antibacterial effectiveness by quantifying Streptococcus mutans biofilm using colony-forming unit (CFU) counts (CFU/mL
Enamel Remineralization Assessed by Raman Spectroscopy
时间窗: day 7
Assessment of mineral content changes in enamel adjacent to aligner material using Raman spectroscopy (e.g., phosphate ν1 peak intensity at \~960 cm-¹).
Ion Release from Modified Aligner Resin
时间窗: day 7
Quantification of calcium (Ca²⁺) and phosphate (PO₄³-) ion release using inductively coupled plasma (ICP) analysis (ppm)
次要结局
- Tensile Properties of Modified 3D-Printed Aligner Resin(After specimen fabrication and post-curing (Day 1))
- Flexural Properties of Modified 3D-Printed Aligner Resin((Day 1))
- Shape Memory(day 1)
- Water Sorption and Solubility(day 1 to day 7)
- Optical Properties: Translucency(day 1)
研究者
Safaa Saud Abed
postgraduate/PhD student
University of Baghdad