Validity of International Caries Classification and Management System (ICCMS) Versus International Caries Detection and Assessment System (ICDAS ) in Caries Assessment : Invivo Diagnostic Study
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Validity of screening system
研究概览
简要总结
- A total of 40 volunteer patients will be assigned in this study.
- All patients will be randomly selected with variable caries risks .
- For each patient The Examiner will use Two screening methods used in caries detection , where D1 represents ICDAS index and D2 represents ICCMS index which are used by each examiner for each patient.
- Each examiner will record the dental findings using the visual- tactile assessment method .The visual-tactile assessment method includes the use of mirror, probe under good illumination condition
- After full caries assessment in the 1st visit , All patients will receive full treatment and oral hygiene control .
- After 6-months follow up re-assessment of same patients will be done by same Examiners .
- The data of each examiner will be collected, and then the repeat-ability and the reproducibility of each method as well as the inter- and intra-operator agreement will be evaluated using the kappa statistics
- Number of visits & follow up period: There will be 2 visits and 6-months follow up between 2 visits.
- Direct benefit of the research to the human volunteer:To get the most appropriate treatment plan .
- Scientific Value and social benefits:obtain better information quality and support Dentist Discussion making.
- Expected risk to human subjects:: the ordinary side effects associated with any restorative treatment and no of the study variable has side effect on the patient and in case of any side effect due to the restorative treatment , the participant will directly contact the operator.
详细描述
- Study setting ----------------------------- The study will be conducted in Conservative Dentistry Department, Faculty of Dentistry, Cairo University, The operator in charge will be: Amr Sobhy Abd Elmounem The researcher will bear ultimate responsibility for all activities associated with the conduct of a research project including recruitment of patients, explaining and performing the procedures to them
- Variables of the study
A total of 40 volunteer patients will be assigned in this study. For each patient Two screening methods will be used in caries detection , where D1 represents ICDAS index and D2 represents ICCMS index which are used by each examiner for each patient 3. Intervention/control assessment:
------------------------------------------- Each examiner will record the dental findings using the visual- tactile assessment method .The visual-tactile assessment method includes the use of mirror, probe under good illumination condition.
a. Control assessment: ICDAS
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
盲法说明
The assessors will not be blind to intervention/control assessment methods. However it will not be allowed amongst the examiners to exchange any information throughout the entire study period
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Articles published in English
- •Articles published after
- •ICDAS & ICCMS
- •Reproducibility
排除标准
- •In any other languages.
- •Articles published before
- •Any other clinical evaluation
结局指标
主要结局
Validity of screening system
时间窗: an average of 1 year
The outcome( Validity) will be measured by measuring Reproducibility of each screening system using Kappa equation .
次要结局
未报告次要终点
研究者
amr sobhy
principal investigator
Cairo University