Assessment of Histochemical Effects of Microplastics Released during Clear Aligner Therapy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Microplastics will be assessed using Fourier Transform Infrared spectroscopy
研究概览
简要总结
AIM:
The study aims to assess the histochemical effects due to microplastics released in
saliva of patients undergoing clear aligner therapy.
OBJECTIVES:
- To assess the presence of microplastics in saliva of patients undergoing clear
aligner therapy
- To analyze the histochemical changes i.e. cytotoxicity, estrogenicity and oxidative
stress caused by these microplastics
The saliva sample will be subjected to the following tests:
a) Fourier Transform Infrared Spectroscopy (FTIR): To assess and characterize the
microplastics present in the saliva sample
b) MTT Assay/ 3-(4,5- dimethylthiazol-2-yl)-2,5-Diphenyl Tetrazolium bromide assay:
To evaluate the cytotoxic effect of the microplastics on primary cultures of human
gingival fibroblasts.
c) MCF-7 cell line test: To assess whether microplastics have estrogenic effects.
d) MPO Assay: To assess whether microplastics have the potential to cause oxidative
stress.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 24.00 Year(s)（—）
- 性别
- All
入选标准
- •Individuals opting for clear aligner therapy 2) Individuals between 18 years to 24 years of age 3) No previous history of orthodontic treatment 4) Individuals willing to participate in the study.
排除标准
- •Individuals who use tobacco in any form 2) Individuals on medications for systemic conditions 3) Individuals under hormonal replacement therapy 4) Individuals with craniofacial syndromes 5) Individuals with poor oral hygiene 6) Individuals with poor periodontal conditions.
结局指标
主要结局
Microplastics will be assessed using Fourier Transform Infrared spectroscopy
时间窗: T0 : control (before onset of treatment) | T1: 1 day after onset of treatment | T2 : 14 days after onset of treatment | T3: 30 days after onset of treatment
The sample will then be tested with:-
时间窗: T0 : control (before onset of treatment) | T1: 1 day after onset of treatment | T2 : 14 days after onset of treatment | T3: 30 days after onset of treatment
1) MTT Assay/ 3-(4,5- dimethylthiazol-2-yl)-2,5-Diphenyl Tetrazolium bromide assay:
时间窗: T0 : control (before onset of treatment) | T1: 1 day after onset of treatment | T2 : 14 days after onset of treatment | T3: 30 days after onset of treatment
To evaluate the cytotoxicity of microplastics on primary cultures of human
时间窗: T0 : control (before onset of treatment) | T1: 1 day after onset of treatment | T2 : 14 days after onset of treatment | T3: 30 days after onset of treatment
gingival fibroblasts.
时间窗: T0 : control (before onset of treatment) | T1: 1 day after onset of treatment | T2 : 14 days after onset of treatment | T3: 30 days after onset of treatment
2) MCF-7 cell line test: To assess estrogenicity of microplastics.
时间窗: T0 : control (before onset of treatment) | T1: 1 day after onset of treatment | T2 : 14 days after onset of treatment | T3: 30 days after onset of treatment
3) MPO Assay: To assess whether microplastics cause oxidative
时间窗: T0 : control (before onset of treatment) | T1: 1 day after onset of treatment | T2 : 14 days after onset of treatment | T3: 30 days after onset of treatment
stress.
时间窗: T0 : control (before onset of treatment) | T1: 1 day after onset of treatment | T2 : 14 days after onset of treatment | T3: 30 days after onset of treatment
次要结局
- The results of this study will emphasize the necessity of adopting sustainable practices. The study aligns with the following Sustainable Development Goals i.e.(SDG 3 Good health & well being)
研究者
Dr Reuben Bensy Thomas
AB Shetty Memorial Institute of Dental Sciences