Clinical trial NCT05890807: Concordance in 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).
Official title: 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).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Complications
Periodontal Diseases
Keywords: Diabetes
Periodontitis
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2023-06-06
Enrollment: 145
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A prospective, single-center, open-label, cross-sectional study to evaluate the concordance of an intervention versus the "gold standard.
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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 1.
* 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.

Primary outcomes:
measure: Parodontitis based on a photograph of the patient's oral cavity (indirect method)
timeFrame: Day 0 to day 7
measure: Parodontitis based on clinical observation of the patient's oral cavity (direct method)
timeFrame: Day 0
Secondary outcomes:
measure: A. Sensitivity and specificity of the Positive Predictive Value (NPV) measured by the indirect method
timeFrame: Day 0 to day 7
measure: A. Sensitivity and specificity of the Negative Predictive Value (NPV) measured by the indirect method
timeFrame: Day 0 to day 7
measure: A. Sensitivity and specificity of the Positive Predictive Value (PPV) measured by the direct method
timeFrame: Day 0
measure: A. Sensitivity and specificity of the Positive Predictive Value (PPV) measured by the indirect method
timeFrame: Day 0 to day 7
measure: B. Quality of photographs taken by the diabetology department : respect of anonymity
timeFrame: Day 0 to day 7
measure: B. Quality of photographs taken by the diabetology department : visibility of the gums
timeFrame: Day 0 to day 7
measure: B. Quality of photographs taken by the diabetology department : image sharpness
timeFrame: Day 0 to day 7
measure: B. Quality of photographs taken by the diabetology department : use of the flash
timeFrame: Day 0 to day 7
measure: B. Quality of photographs taken by the diabetology department : absence of zoom
timeFrame: Day 0 to day 7
measure: B. Quality of photographs taken by the diabetology department : orientation
timeFrame: Day 0 to day 7
measure: B. Percentage of photographs meeting all of the above criteria for acceptance
timeFrame: Day 0 to day 7
measure: C. Association between the patient's diabetic constants and his/her periodontal status. Hospitalization
timeFrame: Day 0
measure: C. Association between the patient's diabetic constants and his/her periodontal status. Type of diabetes
timeFrame: Day 0
measure: C. Association between the patient's diabetic constants and his/her periodontal status. Age of diabetes
timeFrame: Day 0
measure: C. Association between the patient's diabetic constants and his/her periodontal status. Treatment
timeFrame: Day 0
measure: C. Association between the patient's diabetic constants and his/her periodontal status.HbA1c level
timeFrame: Day 0
measure: C. Association between the patient's diabetic constants and his/her periodontal status. Macrovascular complications
timeFrame: Day 0
measure: C. Association between the patient's diabetic constants and his/her periodontal status. Type of macrovascular complication
timeFrame: Day 0
measure: C. Association between the patient's diabetic constants and his/her periodontal status. Microvascular complications
timeFrame: Day 0
measure: C. Association between the patient's diabetic constants and his/her periodontal status. Type of microvascular complication
timeFrame: Day 0
measure: C. Association between the patient's diabetic constants and his/her periodontal status. Smoking
timeFrame: Day 0
measure: C. Association between the patient's diabetic constants and his/her periodontal status. Periodontitis
timeFrame: Day 0
measure: D. Visible clinical signs associated with periodontitis on the photos taken. Inflammation
timeFrame: Day 0 to day 7
measure: D. Visible clinical signs associated with periodontitis on the photos taken. Root tartar
timeFrame: Day 0 to day 7
measure: D. Visible clinical signs associated with periodontitis on the photos taken. Pus
timeFrame: Day 0 to day 7
measure: D. Visible clinical signs associated with periodontitis on the photos taken. Bleeding
timeFrame: Day 0 to day 7
measure: D. Visible clinical signs associated with periodontitis on the photos taken. Interdental space
timeFrame: Day 0 to day 7
measure: D. Visible clinical signs associated with periodontitis on the photos taken. Gum retraction
timeFrame: Day 0 to day 7
measure: D. Visible clinical signs associated with periodontitis on the photos taken. Swollen gums
timeFrame: Day 0 to day 7
measure: D. Visible clinical signs associated with periodontitis on the photos taken. Plaque
timeFrame: Day 0 to day 7
Other outcomes:
measure: Sex of patients
timeFrame: Day 0
measure: Age of patients
timeFrame: Day 0
measure: Type of hospitalization
timeFrame: Day 0
measure: Periodontal status
timeFrame: Day 0
measure: Lifestyle
timeFrame: Day 0
measure: Level of education
timeFrame: Day 0
measure: Professional activity
timeFrame: Day 0
measure: Type of diabetes
timeFrame: Day 0
measure: Diabetic for how long
timeFrame: Day 0
measure: Presence of microangiopathic complications
timeFrame: Day 0
measure: Presence of retinopathy
timeFrame: Day 0
measure: Presence of nephropathy
timeFrame: Day 0
measure: Presence of peripheral neuropathy
timeFrame: Day 0
measure: Glomerular filtration rate (GFR)
timeFrame: Day 0
measure: Dialysis
timeFrame: Day 0
measure: Presence of macroangiopathic complications
timeFrame: Day 0
measure: Presence of obliterative arteritis of the lower limbs
timeFrame: Day 0
measure: Presence of supra-aortic arterial trunk disease
timeFrame: Day 0
measure: Presence of coronary artery disease
timeFrame: Day 0
measure: Oral treatment for diabetes
timeFrame: Day 0
measure: Injectable antidiabetic treatment
timeFrame: Day 0
measure: Other treatments
timeFrame: Day 0
measure: Weight
timeFrame: Day 0
measure: Height
timeFrame: Day 0
measure: Body Mass Index
timeFrame: Day 0
measure: Smoking status
timeFrame: Day 0
measure: Alcohol use
timeFrame: Day 0
measure: Charlson score
timeFrame: Day 0
Locations:
city: Nîmes
country: France
facility: Chu de Nimes
Study officials:
References: