RESTODATA-NUM: A Multicenter Observational Study on the Assessment of Dental Pathologies Using Digital Tools in Adults
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 350
- 试验地点
- 22
- 主要终点
- Number of Decayed, Missing, or Filled Teeth in the permanent dentition, measured both clinically and from intraoral scan (IOS) images using the DMFT index
研究概览
简要总结
Digital technology is playing an increasingly important role in dentistry, because of its ability to support the practitioner and increase work efficiency.
Among digital tools, orthopantomogram (OPT or panoramic) radiography is currently the most widely used. It provides a global view of the jaws, highlighting internal structures in 2D.
As in other fields, scientific advances have made it possible to go beyond the limited representation of two planes of space and obtain 3D images.
The intraoral scanner (IOS) or "optical impression camera" appeared in the mid-80s. They use light to create a digital optical impression that reproduces the surface of external anatomical structures in 3D images. It improves dental practice, making impressions less uncomfortable for patients, saving clinical time, facilitating storage and archiving, and facilitating transmission to the prosthetist where appropriate. This type of device is already well established in dental practices.
More recently, Cone Beam Computed Tomography (CBCT) has also begun to develop. This 3D sectional imaging technique adds an extra dimension to the exploration of internal structures.
Imaging examinations provide additional information to that obtained from the visual clinical oral examination. Together, they help the practitioner to establish the diagnosis and treatment plan.
Currently, visual information has to be collected manually. Collecting this data represents a significant amount of information. Its quality and completeness are crucial to the success of the treatment.
Given the high volume of consultations, and practitioners' need to optimize their time, it would be interesting to assess whether optical impressions, at least in part, could help to acquire this clinical data more systematically and more rapidly, in order to improve patient management.
Similarly, Cone Beam CT (CBCT), with its 3D data, improves the accuracy of diagnostic information. It would also be interesting to assess the real added value of this examination.
The RESTODATA-NUM study follows on from the RESTODATA study, the results of which provided recent information on the oral status of adult patients, and their care needs.
The aim of this study is to compare the performance of a standard real-life examination by the practitioner combining clinical and radiographic examinations (referred to here as practitioner-on-patient detection) on the one hand, and an examination based on imaging results obtained using digital tools on the other, in terms of detecting dental condition in a sample of adult patients consulting for an oral examination at one of the participating centers.
详细描述
Digital technology is playing an increasingly important role in dentistry due to its ability to assist practitioners and enhance work efficiency.
Among digital tools, panoramic radiography (orthopantomogram) is currently the most widely used. It provides a comprehensive image of the jaws, highlighting internal structures in 2D. As in other fields, scientific advances have made it possible to go beyond two-dimensional representations and obtain 3D images.
The intraoral scanner, also known as an "optical impression camera," emerged in the mid-1980s. These devices use light to create a digital optical impression that reproduces the surface of external anatomical structures in 3D images. They improve dental practice by making impression-taking less uncomfortable for patients, saving clinical time, simplifying storage and archiving, and facilitating transmission to dental technicians when needed. This type of device is already well established in dental practices.
More recently, Cone Beam Computed Tomography (CBCT), also known as digital volumetric tomography with a conical beam, has begun to develop. This 3D sectional imaging technique allows for the exploration of internal structures by adding an extra dimension.
Imaging examinations provide additional information that complements the findings of the visual clinical oral examination. Together, they help the practitioner establish a diagnosis and treatment plan. Currently, visual information must be recorded manually. Collecting this data represents a significant amount of information, and the success of treatment partly depends on its quality and completeness.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- 否
入选标准
- •Patients who have read the information sheet and agreed to participate in the study
- •Patients affiliated with a social security scheme
- •Patients aged 18 years or older
- •New patients to the practice or patients who have not visited the practice in the past six months
排除标准
- •Patient who has expressed opposition to participating in the study
- •Age < 18 years
- •Individual under legal guardianship or curatorship
- •Pregnant woman
- •Patient currently undergoing orthodontic treatment with fixed appliances
结局指标
主要结局
Number of Decayed, Missing, or Filled Teeth in the permanent dentition, measured both clinically and from intraoral scan (IOS) images using the DMFT index
时间窗: at the day of the dental examination
Number of Decayed, Missing, or Filled Teeth in the permanent dentition, measured both clinically and from intraoral scan (IOS) images using the DMFT index
次要结局
- Location and extent of carious dental lesions(At the day of the dental examination)
- Location and extent of dental wear lesions(At the day of the dental examination)
- Location, extent, and quality of dental restorations across all detection methods:(At the day of the dental examination)
- Periodontal involvement(At the day of the dental examination)
- Endodontic status(At the day of the dental examination)