Data Collection for a Surface Caries Detection Software
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 88
- 主要终点
- Diagnostic accuracy for surface caries detection software (SCDS) in surface caries detection on visible tooth surfaces compared to clinical visual tactile examination using the International Caries Detection and Assessment System (ICDAS)
研究概览
简要总结
Dental caries (dental cavity) is very common and can impact oral health and oral health-related quality of life. Dental caries is when the tooth surfaces break down, and if left untreated, can cause tooth pain. In routine clinical practice, dental professionals typically assess caries lesions by looking at patients' teeth, touching the areas of interest with a dental probe, and running a probe over the teeth to check the buildup of bacteria.
Dentists often use x-rays to help find cavities, and they can also take pictures of the teeth to show what the problem looks like.
New tools called intraoral scanners are becoming more useful for finding cavities. These scanners do not use radiation and do not hurt. Some computer programs that use artificial intelligence (AI) can also help dentists find cavities. AI can study the spots on patients' teeth and help make better, faster decisions. The purpose of this study is to collect data that will be used to develop and test an AI software that can help dentists in the detection of caries.
详细描述
This is a single-arm, cross-sectional, open single-site clinical investigation using TRIOS 5 and TRIOS 6 intraoral scanners.
After enrolment, the participant will first undergo an intraoral scan. Next, the participant's teeth will be cleaned to remove plaque and debris, ensuring optimal conditions for the caries examination. Dental bitewing radiographs will be taken to assess any potential caries not visible on the scan. A second intraoral scan will be performed on the cleaned teeth. The examiner will then conduct an examination using standardized diagnostic criteria to assess the presence of caries, and will take intraoral photos of the caries lesions.
The AI-based software will provide a digital assessment of caries for comparison with the clinical evaluation. This comparison will be conducted separately from the clinical data collection. The comparison of the AI output to the clinical data will be performed internally at 3Shape headquarters of Holmens Kanal 7, 1060, Copenhagen, Denmark. This test has no impact on the patients in this study.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
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
- •Willing and able to give informed consent for participation in the study
- •Male or female, aged 18 years or above
- •Patients looking for dental treatment
- •Good general health (i.e. absence of any condition that the Principal Investigator evaluates as a risk either to the subject or to the data quality)
- •Able (in the Investigator's opinion) and willing to comply with all study requirements.
- •Minimum of 15 natural teeth without crowns
- •At least one cavitated caries lesion
排除标准
- •Patients with orthodontic appliances and permanent retainers
- •Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study)
- •Patients who are not able or willing to sign the Informed Consent
- •Patients who are currently pregnant. A urine pregnancy test will be administered during the study visit for woman who could be pregnant
结局指标
主要结局
Diagnostic accuracy for surface caries detection software (SCDS) in surface caries detection on visible tooth surfaces compared to clinical visual tactile examination using the International Caries Detection and Assessment System (ICDAS)
时间窗: Baseline
Sensitivity of ≥0.68 and specificity of ≥0.83 for SCDS diagnostic accuracy in surface caries detection on visible tooth surfaces compared to clinical visual tactile examination using the ICDAS
次要结局
未报告次要终点