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临床试验/NCT05064566
NCT05064566Unknown不适用

Clinical Performance of Diagnostic Methods in Early Occlusal Caries

Nazan Kocak Topbas1 个研究点 分布在 1 个国家目标入组 101 人开始时间: 2021年10月20日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
101
试验地点
1
主要终点
Accuracy

研究概览

简要总结

The investigators aim will be to compare the diagnostic performance of clinical visual examination (ICDAS II), intraoral/bite wing radiography (BW), near infrared light transillumination (NIR-LT), and laser fluorescence (LF), in comparison to microcomputed tomography (micro-CT) for the detection of non-cavitated occlusal enamel and dentin caries in third molar teeth. Potential participants will be consecutively recruited.

详细描述

Studies regarding comparison of diagnostic techniques for caries detection are generally conducted under in vitro conditions due to ethical concerns. Considering the many recently published in vitro studies which attempted to assess the diagnostic ability of different caries diagnosis systems, it is not possible to know at what rate in vitro findings are applicable to the clinical situation.The investigators would like to assess initial occlusal caries lesions by using different diagnostic methods under in vivo conditions. In the present study, the investigators will assess diagnostic accuracy of clinical visual examination (ICDAS II), digital intraoral radiography, near infrared light transillumination (NIR-LT), and laser fluorescence (LF), by examining third molar teeth in comparison to gold standard micro-CT images. The null hypothesis of the study is that no significant difference exists for the clinical performance of the evaluated methods in detecting non-cavitated occlusal caries in either the enamel or the dentin. This prospective study will include 101 third molars of 101 patients with non-cavitated occlusal caries requiring extraction. ICDAS II, BW, NIR-LT and LF examinations will be carried out by two examiners. Gold standard will be determined by micro-CT imaging after extraction. Intraclass correlation coefficient (ICC) value will be calculated for examiner agreement. Accuracy rate, sensitivity, specificity, predictive values and areas under receiver operating characteristic curves (Az) will be calculated. Clinical application time and patient comfort/pain analysis will be compared. Nonparametric variables will be assessed by Kruskal Wallis Test. Significance level will be set at p<0.05.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • According to the American Society of Anesthesiologists (ASA) only status 1/ healthy patients
  • Completely erupted permanent dentition,
  • No fixed orthodontic apparatus, prosthetic restoration and filling material,
  • A minimum age of 18 years,
  • At least one third erupted molar teeth (third mandibular or third maxillary molar from each patient was included),
  • Non cavitated occlusal caries,
  • Teeth with no hypoplasia or hypomineralization,
  • Third molar teeth that require extraction for surgery, orthodontics and prosthetic reasons,
  • If clinical indicators suggest a current caries risk or activity that required additional diagnosis, the patients will be asked to participate in this additional examination.

排除标准

  • Patients younger than 18
  • Patients that can not be recruited according to the inclusion criteria.

结局指标

主要结局

Accuracy

时间窗: 1 month

The accuracy of caries detection methods will be evaluated when compared to the gold standard Micro CT.

Receptor operating characteristic (ROC) curves

时间窗: 1 month

Receptor operating characteristic (ROC) curves (Az) will be calculated to show the caries distinguishing ability of each caries detection method and the observer.

Intraclass correlation coefficient (ICC)

时间窗: 1 month

Intra- and inter-observer reproducibility will be assessed by intraclass correlation coefficient (ICC).

次要结局

  • Patient comfort/pain analysis by using Visual Analog Scale (VAS)(comparative assessment of the tests):(1 month)
  • Clinical time efficacy (comparative assessment of the tests)(1 month)

研究者

发起方
Nazan Kocak Topbas
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Nazan Kocak Topbas

Assist. Prof. Dr.

Mersin University

研究点 (1)

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