Evaluation of the Concordance in the Diagnosis of Periodontitis in Diabetic Patients Between an Indirect Method Based on a Photograph of the Oral Cavity and a Direct Method Based on the Clinical Examination of This Oral Cavity (Reference).
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 145
- 试验地点
- 2
- 主要终点
- Parodontitis based on a photograph of the patient's oral cavity (indirect method)
研究概览
简要总结
Periodontitis, a known complication of diabetes, is an infectious disease that destroys bone and gums. Studies have shown that diabetes favors periodontitis, and that periodontitis contributes to its aggravation. The positive impact of treating periodontitis on the cost of diabetes care has been demonstrated and the French national health system fully covers the treatment of periodontitis for diabetic patients. Unfortunately, 80% of diabetic patients do not visit their dentist enough.
Although diabetologists regularly see their patients and are aware of the importance of treating periodontitis,they do not have the expertise to diagnose the condition whereas a specialist dentist can often diagnose it just by looking.
This study aims to develop a solution combining the dentist's expertise with that of the diabetologist. This would be based on analysis of a photograph of the patient's oral cavity, taken in the department. So far, no studies have ever evaluated the performance of an expert dentist for diagnosing periodontitis from a simple photograph made by non-dental experts in a diabetic department.
The hypothesis is that the concordance in the diagnosis of periodontitis between an indirect method based on a photograph of the oral cavity and a direct method based on clinical examination of this oral cavity (reference) in the diabetic patient would be satisfactory.
详细描述
Among the complications of diabetes, periodontitis, an infectious disease that destroys the bone and gums, has a bidirectional relationship with diabetes. Indeed, studies have shown that diabetes favors periodontitis, and that periodontitis contributes to the aggravation of diabetes. In addition, the positive impact of treating periodontitis on the indicators and cost of diabetes management has been demonstrated. To echo these findings, since 2020, the French national health scheme now fully covers the treatment of periodontitis in diabetic patients. Unfortunately, health insurance reports point out that 80% of diabetic patients do not visit their dentist enough.
This makes it difficult to detect and treat periodontitis in diabetic patients at an early stage. At the same time, diabetologists who regularly see their patients confirm the importance of knowing their periodontal condition. But they do not have the expertise to diagnose periodontitis whereas, in most cases, a specialist dentist could diagnose it just by looking. The development of a solution allowing the dentist's expertise to be brought to the service of diabetes may have a positive impact on the management of diabetic patients with periodontitis. This expertise could be based on analyzing a photograph of the patient's oral cavity, taken in the department. So far, no studies have ever evaluated the performance of an expert dentist for diagnosing periodontitis from a simple photograph, made by non-dental experts in a diabetic department.
The hypothesis is that the concordance in the diagnosis of periodontitis between an indirect method based on a photograph of the oral cavity and a direct method based on clinical examination of this oral cavity (reference) in the diabetic patient would be satisfactory.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with type 1 or 2 diabetes.
- •Patients of legal age (≥ 18 years).
- •Patient undergoing day or weekday hospitalization in the Metabolic and Endocrine Diseases Department at Nîmes University Hospital.
- •Patient who has not reported his or her opposition to participating in the study.
- •Patient affiliated or beneficiary of a health insurance plan.
排除标准
- •Patient who has received treatment for periodontal disease within the past 12 months.
- •Patient with fewer (<) than 3 functional contiguous teeth.
- •Patient participating in research involving human subjects defined as category
- •Patient in an exclusion period as determined by another study.
- •Patient under court protection, guardianship, or conservatorship.
- •Patient for whom informed information cannot be provided.
- •Patient who is pregnant or breastfeeding.
结局指标
主要结局
Parodontitis based on a photograph of the patient's oral cavity (indirect method)
时间窗: Day 0 to day 7
For the indirect method, two expert dentists will independently analyze the photographs in order to decide whether YES / NO the patient has parodontitis.
Parodontitis based on clinical observation of the patient's oral cavity (direct method)
时间窗: Day 0
For the direct method by clinical examination, an expert dentist different from those involved in the indirect method will decide whether YES / NO the patient has parodontitis.
次要结局
- A. Sensitivity and specificity of the Positive Predictive Value (PPV) measured by the indirect method(Day 0 to day 7)
- A. Sensitivity and specificity of the Positive Predictive Value (NPV) measured by the indirect method(Day 0 to day 7)
- B. Quality of photographs taken by the diabetology department : image sharpness(Day 0 to day 7)
- B. Quality of photographs taken by the diabetology department : use of the flash(Day 0 to day 7)
- B. Percentage of photographs meeting all of the above criteria for acceptance(Day 0 to day 7)
- B. Quality of photographs taken by the diabetology department : respect of anonymity(Day 0 to day 7)
- C. Association between the patient's diabetic constants and his/her periodontal status. Macrovascular complications(Day 0)
- D. Visible clinical signs associated with periodontitis on the photos taken. Interdental space(Day 0 to day 7)
- D. Visible clinical signs associated with periodontitis on the photos taken. Gum retraction(Day 0 to day 7)
- A. Sensitivity and specificity of the Negative Predictive Value (NPV) measured by the indirect method(Day 0 to day 7)
- A. Sensitivity and specificity of the Positive Predictive Value (PPV) measured by the direct method(Day 0)
- C. Association between the patient's diabetic constants and his/her periodontal status. Treatment(Day 0)
- C. Association between the patient's diabetic constants and his/her periodontal status. Type of macrovascular complication(Day 0)
- C. Association between the patient's diabetic constants and his/her periodontal status. Periodontitis(Day 0)
- D. Visible clinical signs associated with periodontitis on the photos taken. Swollen gums(Day 0 to day 7)
- B. Quality of photographs taken by the diabetology department : visibility of the gums(Day 0 to day 7)
- B. Quality of photographs taken by the diabetology department : absence of zoom(Day 0 to day 7)
- B. Quality of photographs taken by the diabetology department : orientation(Day 0 to day 7)
- C. Association between the patient's diabetic constants and his/her periodontal status. Type of diabetes(Day 0)
- C. Association between the patient's diabetic constants and his/her periodontal status. Type of microvascular complication(Day 0)
- D. Visible clinical signs associated with periodontitis on the photos taken. Inflammation(Day 0 to day 7)
- D. Visible clinical signs associated with periodontitis on the photos taken. Root tartar(Day 0 to day 7)
- D. Visible clinical signs associated with periodontitis on the photos taken. Pus(Day 0 to day 7)
- D. Visible clinical signs associated with periodontitis on the photos taken. Bleeding(Day 0 to day 7)
- D. Visible clinical signs associated with periodontitis on the photos taken. Plaque(Day 0 to day 7)
- C. Association between the patient's diabetic constants and his/her periodontal status. Microvascular complications(Day 0)
- C. Association between the patient's diabetic constants and his/her periodontal status. Smoking(Day 0)
- C. Association between the patient's diabetic constants and his/her periodontal status. Hospitalization(Day 0)
- C. Association between the patient's diabetic constants and his/her periodontal status. Age of diabetes(Day 0)
- C. Association between the patient's diabetic constants and his/her periodontal status.HbA1c level(Day 0)