A Clinical Study to Compare Caries Detection in Children Between the iTero Element 5D System (NIRI=Near Infra Red Imaging) and Bitewing Radiographs (BWR) as a Diagnostic Aid for the Detection of Primary Carious Lesions Above the Gingiva.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Non-inferiority of the iTero 5D compared to BWR in dental caries detection
研究概览
简要总结
This is a non-significant risk, single site, prospective clinical study. The study will be conducted in the department of pediatric dentistry of the faculty of dental medicine of the Hebrew university, Israel
详细描述
This is a non-significant risk, single site, prospective study to be conducted in the department of pediatric dentistry of the Hadassah Medical Center, Faculty of Dental Medicine, Hebrew University of Jerusalem, Israel. Subject participation will require one visit during which consent, screening, enrollment, and imaging will be performed.
Clinical and diagnostic methods to be used during this study are those that are routinely used in the diagnosis of caries in this site, which include bitewing radiographs (BWR). This standard of care is provided for all site's patients, including the patients who don't participate in this clinical study.
A standard set of BWR for subjects ages 4-9 years will be taken to include the complete dentition of the subjects. No additional x-ray should be taken for the sole purpose of this trial.
In addition to the routine clinical diagnostics, the subjects will be scanned using the 5D system. The investigator will capture a full arch scan of the maxillary arch and mandibular arch of each subject with the iTero Element 5D system. For each subject, the Investigator will grade carious lesions in the BWR and Element intra-oral scan according to ADA staging guidelines. The results will be documented using Caries Evaluation Forms. The Investigator will assess and document the findings of each diagnostic test separately before reviewing the next test.
In cases where caries debridement is indicated, carious lesion depth will be documented during and compared to NIRI and BWR images.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ages 4-9 years
- •Subjects scheduled for bilateral BWR as part of their standard of care
- •Subjects with a recent bilateral BWR which were obtained up to 14 days prior to study visit
排除标准
- •Subjects who have been diagnosed with epilepsy
- •Subjects with a known allergy to latex or plastic
- •Subjects with allergies to any dental or oral health products
- •Subjects who have undergone a dental treatment since the acquisition of the recent bilateral BWR
结局指标
主要结局
Non-inferiority of the iTero 5D compared to BWR in dental caries detection
时间窗: Grading the carious lesions for the first 20 subjects will be conducted up to 2 month from completion the first 20 subjects visits. The rest 50 subjects will be evaluated up to 1 month from completion the last subject visit.
For each subject, the Investigator will grade carious lesions in the BWR and Element intra-oral scan (NIRI) according to ADA staging guidelines. The results will be documented using Caries Evaluation Forms for BWR and for Element intra-oral scan . The Investigator will assess and document the findings of each diagnostic test separately before reviewing the next test. The iTero 5D performance will be non-inferior to BWR performance in detecting the existence of primary interproximal caries lesions above the gingiva in pediatric population. The study will include an interim analysis to assess the iTero Element 5D system usability among the first 20 pediatric subjects.
次要结局
- To compare users' experience using a qualitative questionnaire(The questionnaire will be filled immediately after the intra-oral scan for each subject. Final report of the comparison will be generated up to 15 weeks from last subject visit.)
研究者
Moti Moskovitz
Prof. Moti Moskovitz DMD, PhD. Director of Postgraduate Program-Dept. of Pediatric Dentistry, Hadassah Medical Center, Faculty of Dental Medicine, Hebrew University of Jerusalem, Israel
Hadassah Medical Organization