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临床试验/NCT03038412
NCT03038412Unknown不适用

Clinical Detection and Quantification of Caries and Dental Plaque Based on Auto-fluorescence Imaging System: An Observational Study

Hui Chen0 个研究点目标入组 60 人开始时间: 2016年5月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
60
主要终点
Auto-fluorescence image assessment

研究概览

简要总结

The purpose of this study was to evaluate the applicability of auto-fluorescence imaging system to detect and quantify caries and dental plaque. Participants were advised to rinse their mouth with distilled water to exclude any chance of fluorescence from food debris. A well trained physicist majored in optical spectroscopy captured auto-fluorescence images of buccal aspects of two maxillary central incisors and occlusal aspects of four first molars from each patient in a dark room. Then they chewed a disclosing agent to assess the Quigley Hein plaque index modified by Turesky of each tooth. Furthermore, participants were also required to brush their teeth for 3min, then International Caries Detection and Assessment System(ICDAS)codes of relevant teeth to evaluate degrees of caries were recorded by an experienced dentist using a mouth mirror and explorer. The Spearman rank correlation coefficient between colorimetric parameters of fluorescence image and the plaque index and ICDAS code were calculated to evaluate the sensitivity and specificity of auto-fluorescence imaging system.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 54 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Subjects were required to:
  • have two maxillary central incisors and four first molars in mouth;
  • have caries in their mouth or have a high risk to get caries and need to be treated by dentists ;
  • sign informed consent form.

排除标准

  • 1.two incisors and four first molars of participants ever received endodontics treatment;
  • history of antibiotics, mouthwashes, or any periodontal treatment during the last 3 months;
  • 3.with calculus and cementum exposed in tooth cervical;
  • active systemic disease;
  • physical or mental disability;
  • pregnant or lactating.

结局指标

主要结局

Auto-fluorescence image assessment

时间窗: 1 week after image collection

Colorimetric parameters of auto-fluorescence images of buccal aspects of two maxillary central incisors and occlusal aspects of four first molars from each patient were calculated to get the Percentage Plaque Index (PPI). PPI is defined as the ratio between area of dental plaque on teeth and the whole teeth area.

The Quigley Hein plaque index modified by Turesky

时间窗: right after disclosing

After disclosing dental plaque, plaque index was evaluated as following scoring system:0 no plaque; 1. separate flecks of plaque at the cervical margin of the margin of the tooth; 2. a thin continuous band of plaque (up to 1 mm) at the cervical margin; 3. a band of plaque wider than 1 mm but covering less than (1/3)rd of crown; 4. plaque covering at least (1/3)rd but less than (2/3)rd of the crown; 5. plaque covering (2/3)rd or more of the crown

ICDAS scoring results

时间窗: right after oral detection

After brushing teeth, ICDAS codes were recorded by an experienced dentist using a mouth mirror and explorer:0 sound; 1. first visual change in enamel; 2. distinct visual change in enamel; 3. localized enamel breakdown; 4. underlying dentine shadow; 5. distinct cavity with visible dentine; 6. extensive cavity within visible dentine.

次要结局

未报告次要终点

研究者

发起方
Hui Chen
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Hui Chen

Professor

The Dental Hospital of Zhejiang University School of Medicine

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