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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). (PARODIABNOSTIC)

Primary Purpose

Diabetes Complications, Periodontal Diseases

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Front view photography of the patient's oral cavity with the help of a smartphone in the diabetology department.
Sponsored by
Centre Hospitalier Universitaire de Nīmes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Diabetes Complications focused on measuring Diabetes, Periodontitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Chu de NimesRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients whose oral cavity will be photographed in the diabetology department

Arm Description

The patient is seated in the chair. The trained staff member positions the mouth guard and takes a frontal photograph of the patient's oral cavity using the photo sensor (smart-phone). Only the oral cavity will be visible in the photograph and there will be no possibility for an external assessor to recognize the patient's face.

Outcomes

Primary Outcome Measures

Parodontitis based on a photograph of the patient's oral cavity (indirect method)
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)
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.

Secondary Outcome Measures

A. Sensitivity and specificity of the Positive Predictive Value (NPV) measured by the indirect method
Positive predictive value = True Positive / (True Positives+False Positives)
A. Sensitivity and specificity of the Negative Predictive Value (NPV) measured by the indirect method
Negative predictive value = True Negative / (False Negatives + True Negatives)
A. Sensitivity and specificity of the Positive Predictive Value (PPV) measured by the direct method
Positive predictive value = True Positive / (True Positives+False Positives)
A. Sensitivity and specificity of the Positive Predictive Value (PPV) measured by the indirect method
Negative predictive value = True Negative / (False Negatives+True Negatives)
B. Quality of photographs taken by the diabetology department : respect of anonymity
Evaluation of the photograph by two expert dentists who check compliance with the rules established for taking the photo. During the research or at its conclusion, the data collected on the persons who lend themselves to it and transmitted to the sponsor by the investigators (or any other specialized intervening parties) will be made anonymous. Under no circumstances will the names of the persons concerned or their addresses appear in clear text. The patient will be identified only by a unique seven-digit identification number. A list of subject identifications will be kept in the investigator's file. The investigator will ensure that the anonymity of each individual participating in the study is guaranteed. No identifying information will be given to any third party other than those who are authorized by law to hold such information (and who are bound by professional secrecy).
B. Quality of photographs taken by the diabetology department : visibility of the gums
Two expert dentists will check compliance with the rules established for taking the photo. For sufficient diagnostic quality, the gums must be clearly visible. "Periodontal disease" describes all gingivitis and periodontitis. Gingivitis is characterized by gingival inflammation manifested by redness of the gums, bleeding and localized edema. The inflammatory process only affects the superficial periodontium (gingival epithelium and gingival connective tissue) and is most often due to an accumulation of bacterial plaque. However, it can be reversed with specific oral hygiene measures. When the deep periodontal tissues (alveolar bone, periodontal ligament, cementum) are affected it is called periodontitis. These lesions are clinically characterized by gingival inflammation and a periodontal pocket (space that is created between the tooth and the gum) as well as by bone loss.
B. Quality of photographs taken by the diabetology department : image sharpness
Evaluation of the photograph by two expert dentists who check compliance with the rules established for taking the photo. Is the image sharpness good enough to clearly visualize the patient's gums? YES/NO
B. Quality of photographs taken by the diabetology department : use of the flash
Evaluation of the photograph by two expert dentists who check compliance with the rules established for taking the photo. Was the flash used ? YES/NO
B. Quality of photographs taken by the diabetology department : absence of zoom
Evaluation of the photograph by two expert dentists who check compliance with the rules established for taking the photo.Was the zoom used? YES/NO
B. Quality of photographs taken by the diabetology department : orientation
Evaluation of the photograph by two expert dentists who check compliance with the rules established for taking the photo. Was the photo taken from full front view ? YES/NO
B. Percentage of photographs meeting all of the above criteria for acceptance
The number of photographs that meet all the above acceptance criteria will be converted into a percentage.
C. Association between the patient's diabetic constants and his/her periodontal status. Hospitalization
Diabetic findings according to the following criteria recorded for each patient included: - the type of hospitalization (day or week)
C. Association between the patient's diabetic constants and his/her periodontal status. Type of diabetes
Diabetic findings according to the following criteria recorded for each patient included: -the type of diabetes (Type I, Type II or other)
C. Association between the patient's diabetic constants and his/her periodontal status. Age of diabetes
Diabetic findings according to the following criteria recorded for each patient included: - Age of diabetes: <1 year, 1-5 years, 5-10 years, 10-20 years, >20 years
C. Association between the patient's diabetic constants and his/her periodontal status. Treatment
Diabetic findings according to the following criteria recorded for each patient included: -treatment: insulin therapy yes/no and the drug used (metformin, hypoglycemic sulfonamides, dipeptidyl peptidase IV inhibitors, SGLT2 inhibitors, GLP1 analogues, other) will be recorded.
C. Association between the patient's diabetic constants and his/her periodontal status.HbA1c level
Diabetic findings according to the following criteria recorded for each patient included: - the patient's HbA1c level will be recorded in mmol/mol
C. Association between the patient's diabetic constants and his/her periodontal status. Macrovascular complications
Diabetic findings according to the following criteria recorded for each patient included: -Presence of macrovascular complications will be recorded as YES/NO
C. Association between the patient's diabetic constants and his/her periodontal status. Type of macrovascular complication
Diabetic findings according to the following criteria recorded for each patient included: -The type of macrovascular complication : arteriopathy (cerebral, coronary, lower limbs) will be recorded
C. Association between the patient's diabetic constants and his/her periodontal status. Microvascular complications
Diabetic findings according to the following criteria recorded for each patient included: -presence of microvascular complications, YES/NO
C. Association between the patient's diabetic constants and his/her periodontal status. Type of microvascular complication
Diabetic findings according to the following criteria recorded for each patient included: -The type of microvascular complication (retinopathy, nephropathy, neuropathy) will be recorded
C. Association between the patient's diabetic constants and his/her periodontal status. Smoking
Diabetic findings according to the following criteria recorded for each patient included: - the patient's smoking status (active/number of cigarettes per day/ex-smoker) will be recorded
C. Association between the patient's diabetic constants and his/her periodontal status. Periodontitis
Diabetic findings according to the following criteria recorded for each patient included: Presence of periodontitis (yes/no) according to the reference method, i.e. by odontological examination.
D. Visible clinical signs associated with periodontitis on the photos taken. Inflammation
Evaluation of clinical signs visible on the photos of diabetic patients diagnosed with periodontitis according to the gold standard (odontological examination): -Inflammatory color of the gum The evaluation will be interpreted by two blinded expert dentists (different from the one who performed the odontological examination) at the end of the inclusion period. Observation of the photographs by two expert dentists.
D. Visible clinical signs associated with periodontitis on the photos taken. Root tartar
Evaluation of clinical signs visible on the photos of diabetic patients diagnosed with periodontitis according to the gold standard (odontological examination): -Root tartar The evaluation will be interpreted by two blinded expert dentists (different from the one who performed the odontological examination) at the end of the inclusion period. Observation of the photographs by two expert dentists.
D. Visible clinical signs associated with periodontitis on the photos taken. Pus
Evaluation of clinical signs visible on the photos of diabetic patients diagnosed with periodontitis according to the gold standard (odontological examination): -Pus The evaluation will be interpreted by two blinded expert dentists (different from the one who performed the odontological examination) at the end of the inclusion period. Observation of the photographs by two expert dentists.
D. Visible clinical signs associated with periodontitis on the photos taken. Bleeding
Evaluation of clinical signs visible on the photos of diabetic patients diagnosed with periodontitis according to the gold standard (odontological examination): -Bleeding The evaluation will be interpreted by two blinded expert dentists (different from the one who performed the odontological examination) at the end of the inclusion period. Observation of the photographs by two expert dentists.
D. Visible clinical signs associated with periodontitis on the photos taken. Interdental space
Evaluation of clinical signs visible on the photos of diabetic patients diagnosed with periodontitis according to the gold standard (odontological examination): -Interdental space The evaluation will be interpreted by two blinded expert dentists (different from the one who performed the odontological examination) at the end of the inclusion period. Observation of the photographs by two expert dentists.
D. Visible clinical signs associated with periodontitis on the photos taken. Gum retraction
Evaluation of clinical signs visible on the photos of diabetic patients diagnosed with periodontitis according to the gold standard (odontological examination): -Retraction of the gum The evaluation will be interpreted by two blinded expert dentists (different from the one who performed the odontological examination) at the end of the inclusion period. Observation of the photographs by two expert dentists.
D. Visible clinical signs associated with periodontitis on the photos taken. Swollen gums
Evaluation of clinical signs visible on the photos of diabetic patients diagnosed with periodontitis according to the gold standard (odontological examination): -Gum swelling The evaluation will be interpreted by two blinded expert dentists (different from the one who performed the odontological examination) at the end of the inclusion period. Observation of the photographs by two expert dentists.
D. Visible clinical signs associated with periodontitis on the photos taken. Plaque
Evaluation of clinical signs visible on the photos of diabetic patients diagnosed with periodontitis according to the gold standard (odontological examination): -Dental plaque The evaluation will be interpreted by two blinded expert dentists (different from the one who performed the odontological examination) at the end of the inclusion period. Observation of the photographs by two expert dentists.

Full Information

First Posted
May 15, 2023
Last Updated
June 13, 2023
Sponsor
Centre Hospitalier Universitaire de Nīmes
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1. Study Identification

Unique Protocol Identification Number
NCT05890807
Brief Title
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).
Acronym
PARODIABNOSTIC
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 20, 2023 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
July 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nīmes

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Complications, Periodontal Diseases
Keywords
Diabetes, Periodontitis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
A prospective, single-center, open-label, cross-sectional study to evaluate the concordance of an intervention versus the "gold standard.
Masking
None (Open Label)
Allocation
N/A
Enrollment
145 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients whose oral cavity will be photographed in the diabetology department
Arm Type
Experimental
Arm Description
The patient is seated in the chair. The trained staff member positions the mouth guard and takes a frontal photograph of the patient's oral cavity using the photo sensor (smart-phone). Only the oral cavity will be visible in the photograph and there will be no possibility for an external assessor to recognize the patient's face.
Intervention Type
Diagnostic Test
Intervention Name(s)
Front view photography of the patient's oral cavity with the help of a smartphone in the diabetology department.
Intervention Description
The diabetologist will take a photograph of the patient's oral cavity in the diabetology department.
Primary Outcome Measure Information:
Title
Parodontitis based on a photograph of the patient's oral cavity (indirect method)
Description
For the indirect method, two expert dentists will independently analyze the photographs in order to decide whether YES / NO the patient has parodontitis.
Time Frame
Day 0
Title
Parodontitis based on clinical observation of the patient's oral cavity (direct method)
Description
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.
Time Frame
Day 0
Secondary Outcome Measure Information:
Title
A. Sensitivity and specificity of the Positive Predictive Value (NPV) measured by the indirect method
Description
Positive predictive value = True Positive / (True Positives+False Positives)
Time Frame
Day 0
Title
A. Sensitivity and specificity of the Negative Predictive Value (NPV) measured by the indirect method
Description
Negative predictive value = True Negative / (False Negatives + True Negatives)
Time Frame
Day 0
Title
A. Sensitivity and specificity of the Positive Predictive Value (PPV) measured by the direct method
Description
Positive predictive value = True Positive / (True Positives+False Positives)
Time Frame
Day 0
Title
A. Sensitivity and specificity of the Positive Predictive Value (PPV) measured by the indirect method
Description
Negative predictive value = True Negative / (False Negatives+True Negatives)
Time Frame
Day 0
Title
B. Quality of photographs taken by the diabetology department : respect of anonymity
Description
Evaluation of the photograph by two expert dentists who check compliance with the rules established for taking the photo. During the research or at its conclusion, the data collected on the persons who lend themselves to it and transmitted to the sponsor by the investigators (or any other specialized intervening parties) will be made anonymous. Under no circumstances will the names of the persons concerned or their addresses appear in clear text. The patient will be identified only by a unique seven-digit identification number. A list of subject identifications will be kept in the investigator's file. The investigator will ensure that the anonymity of each individual participating in the study is guaranteed. No identifying information will be given to any third party other than those who are authorized by law to hold such information (and who are bound by professional secrecy).
Time Frame
Day 0
Title
B. Quality of photographs taken by the diabetology department : visibility of the gums
Description
Two expert dentists will check compliance with the rules established for taking the photo. For sufficient diagnostic quality, the gums must be clearly visible. "Periodontal disease" describes all gingivitis and periodontitis. Gingivitis is characterized by gingival inflammation manifested by redness of the gums, bleeding and localized edema. The inflammatory process only affects the superficial periodontium (gingival epithelium and gingival connective tissue) and is most often due to an accumulation of bacterial plaque. However, it can be reversed with specific oral hygiene measures. When the deep periodontal tissues (alveolar bone, periodontal ligament, cementum) are affected it is called periodontitis. These lesions are clinically characterized by gingival inflammation and a periodontal pocket (space that is created between the tooth and the gum) as well as by bone loss.
Time Frame
Day 0
Title
B. Quality of photographs taken by the diabetology department : image sharpness
Description
Evaluation of the photograph by two expert dentists who check compliance with the rules established for taking the photo. Is the image sharpness good enough to clearly visualize the patient's gums? YES/NO
Time Frame
Day 0
Title
B. Quality of photographs taken by the diabetology department : use of the flash
Description
Evaluation of the photograph by two expert dentists who check compliance with the rules established for taking the photo. Was the flash used ? YES/NO
Time Frame
Day 0
Title
B. Quality of photographs taken by the diabetology department : absence of zoom
Description
Evaluation of the photograph by two expert dentists who check compliance with the rules established for taking the photo.Was the zoom used? YES/NO
Time Frame
Day 0
Title
B. Quality of photographs taken by the diabetology department : orientation
Description
Evaluation of the photograph by two expert dentists who check compliance with the rules established for taking the photo. Was the photo taken from full front view ? YES/NO
Time Frame
Day 0
Title
B. Percentage of photographs meeting all of the above criteria for acceptance
Description
The number of photographs that meet all the above acceptance criteria will be converted into a percentage.
Time Frame
Day 0
Title
C. Association between the patient's diabetic constants and his/her periodontal status. Hospitalization
Description
Diabetic findings according to the following criteria recorded for each patient included: - the type of hospitalization (day or week)
Time Frame
Day 0
Title
C. Association between the patient's diabetic constants and his/her periodontal status. Type of diabetes
Description
Diabetic findings according to the following criteria recorded for each patient included: -the type of diabetes (Type I, Type II or other)
Time Frame
Day 0
Title
C. Association between the patient's diabetic constants and his/her periodontal status. Age of diabetes
Description
Diabetic findings according to the following criteria recorded for each patient included: - Age of diabetes: <1 year, 1-5 years, 5-10 years, 10-20 years, >20 years
Time Frame
Day 0
Title
C. Association between the patient's diabetic constants and his/her periodontal status. Treatment
Description
Diabetic findings according to the following criteria recorded for each patient included: -treatment: insulin therapy yes/no and the drug used (metformin, hypoglycemic sulfonamides, dipeptidyl peptidase IV inhibitors, SGLT2 inhibitors, GLP1 analogues, other) will be recorded.
Time Frame
Day 0
Title
C. Association between the patient's diabetic constants and his/her periodontal status.HbA1c level
Description
Diabetic findings according to the following criteria recorded for each patient included: - the patient's HbA1c level will be recorded in mmol/mol
Time Frame
Day 0
Title
C. Association between the patient's diabetic constants and his/her periodontal status. Macrovascular complications
Description
Diabetic findings according to the following criteria recorded for each patient included: -Presence of macrovascular complications will be recorded as YES/NO
Time Frame
Day 0
Title
C. Association between the patient's diabetic constants and his/her periodontal status. Type of macrovascular complication
Description
Diabetic findings according to the following criteria recorded for each patient included: -The type of macrovascular complication : arteriopathy (cerebral, coronary, lower limbs) will be recorded
Time Frame
Day 0
Title
C. Association between the patient's diabetic constants and his/her periodontal status. Microvascular complications
Description
Diabetic findings according to the following criteria recorded for each patient included: -presence of microvascular complications, YES/NO
Time Frame
Day 0
Title
C. Association between the patient's diabetic constants and his/her periodontal status. Type of microvascular complication
Description
Diabetic findings according to the following criteria recorded for each patient included: -The type of microvascular complication (retinopathy, nephropathy, neuropathy) will be recorded
Time Frame
Day 0
Title
C. Association between the patient's diabetic constants and his/her periodontal status. Smoking
Description
Diabetic findings according to the following criteria recorded for each patient included: - the patient's smoking status (active/number of cigarettes per day/ex-smoker) will be recorded
Time Frame
Day 0
Title
C. Association between the patient's diabetic constants and his/her periodontal status. Periodontitis
Description
Diabetic findings according to the following criteria recorded for each patient included: Presence of periodontitis (yes/no) according to the reference method, i.e. by odontological examination.
Time Frame
Day 0
Title
D. Visible clinical signs associated with periodontitis on the photos taken. Inflammation
Description
Evaluation of clinical signs visible on the photos of diabetic patients diagnosed with periodontitis according to the gold standard (odontological examination): -Inflammatory color of the gum The evaluation will be interpreted by two blinded expert dentists (different from the one who performed the odontological examination) at the end of the inclusion period. Observation of the photographs by two expert dentists.
Time Frame
Day 0
Title
D. Visible clinical signs associated with periodontitis on the photos taken. Root tartar
Description
Evaluation of clinical signs visible on the photos of diabetic patients diagnosed with periodontitis according to the gold standard (odontological examination): -Root tartar The evaluation will be interpreted by two blinded expert dentists (different from the one who performed the odontological examination) at the end of the inclusion period. Observation of the photographs by two expert dentists.
Time Frame
Day 0
Title
D. Visible clinical signs associated with periodontitis on the photos taken. Pus
Description
Evaluation of clinical signs visible on the photos of diabetic patients diagnosed with periodontitis according to the gold standard (odontological examination): -Pus The evaluation will be interpreted by two blinded expert dentists (different from the one who performed the odontological examination) at the end of the inclusion period. Observation of the photographs by two expert dentists.
Time Frame
Day 0
Title
D. Visible clinical signs associated with periodontitis on the photos taken. Bleeding
Description
Evaluation of clinical signs visible on the photos of diabetic patients diagnosed with periodontitis according to the gold standard (odontological examination): -Bleeding The evaluation will be interpreted by two blinded expert dentists (different from the one who performed the odontological examination) at the end of the inclusion period. Observation of the photographs by two expert dentists.
Time Frame
Day 0
Title
D. Visible clinical signs associated with periodontitis on the photos taken. Interdental space
Description
Evaluation of clinical signs visible on the photos of diabetic patients diagnosed with periodontitis according to the gold standard (odontological examination): -Interdental space The evaluation will be interpreted by two blinded expert dentists (different from the one who performed the odontological examination) at the end of the inclusion period. Observation of the photographs by two expert dentists.
Time Frame
Day 0
Title
D. Visible clinical signs associated with periodontitis on the photos taken. Gum retraction
Description
Evaluation of clinical signs visible on the photos of diabetic patients diagnosed with periodontitis according to the gold standard (odontological examination): -Retraction of the gum The evaluation will be interpreted by two blinded expert dentists (different from the one who performed the odontological examination) at the end of the inclusion period. Observation of the photographs by two expert dentists.
Time Frame
Day 0
Title
D. Visible clinical signs associated with periodontitis on the photos taken. Swollen gums
Description
Evaluation of clinical signs visible on the photos of diabetic patients diagnosed with periodontitis according to the gold standard (odontological examination): -Gum swelling The evaluation will be interpreted by two blinded expert dentists (different from the one who performed the odontological examination) at the end of the inclusion period. Observation of the photographs by two expert dentists.
Time Frame
Day 0
Title
D. Visible clinical signs associated with periodontitis on the photos taken. Plaque
Description
Evaluation of clinical signs visible on the photos of diabetic patients diagnosed with periodontitis according to the gold standard (odontological examination): -Dental plaque The evaluation will be interpreted by two blinded expert dentists (different from the one who performed the odontological examination) at the end of the inclusion period. Observation of the photographs by two expert dentists.
Time Frame
Day 0
Other Pre-specified Outcome Measures:
Title
Sex of patients
Description
Male/female
Time Frame
Day 0
Title
Age of patients
Description
In years
Time Frame
Day 0
Title
Type of hospitalization
Description
Inpatients/Outpatients
Time Frame
Day 0
Title
Periodontal status
Description
Periodontitis / gingivitis / healthy
Time Frame
Day 0
Title
Lifestyle
Description
Lives alone / Lives with family or nearby / Homeless
Time Frame
Day 0
Title
Level of education
Description
Primary / Secondary / Graduate / Post-graduate
Time Frame
Day 0
Title
Professional activity
Description
Employed / Full-time/ Part-time/ Unemployed
Time Frame
Day 0
Title
Type of diabetes
Description
Type 1 / Type 2 / Unknown / Other
Time Frame
Day 0
Title
Diabetic for how long
Description
More than 20 years / 10 to 20 years / 5 to 10 years / Less than 5 years / Unknown
Time Frame
Day 0
Title
Presence of microangiopathic complications
Description
YES / NO
Time Frame
Day 0
Title
Presence of retinopathy
Description
YES / NO / Don't know
Time Frame
Day 0
Title
Presence of nephropathy
Description
YES / NO / Don't know
Time Frame
Day 0
Title
Presence of peripheral neuropathy
Description
YES / NO / Don't know
Time Frame
Day 0
Title
Glomerular filtration rate (GFR)
Description
GFR between 60 and 89 ml/min/1.73 m² GFR between 45 and 59 ml/min/1.73 m² GFR between 30 and 44 ml/min/1.73 m² GFR between 15 and 29 ml/min/1.73 m² GFR < 15 ml/min/1.73 m²
Time Frame
Day 0
Title
Dialysis
Description
YES / NO
Time Frame
Day 0
Title
Presence of macroangiopathic complications
Description
YES / NO
Time Frame
Day 0
Title
Presence of obliterative arteritis of the lower limbs
Description
YES / NO / Don't know
Time Frame
Day 0
Title
Presence of supra-aortic arterial trunk disease
Description
YES / NO / Don't know
Time Frame
Day 0
Title
Presence of coronary artery disease
Description
YES / NO / Don't know
Time Frame
Day 0
Title
Oral treatment for diabetes
Description
Biguanides / Glucose-lowering sulfonamides / Glinides / Dipeptidyl Peptidase-IV / A-glucosidase inhibitors / SGLT2 inhibitors / None
Time Frame
Day 0
Title
Injectable antidiabetic treatment
Description
Fast/ultra-fast insulin / Slow/ultra-slow insulin / GLP1 analogues / none
Time Frame
Day 0
Title
Other treatments
Description
Yes / No If yes specify: Corticosteroids / Chemotherapy / Immunosuppressors / Immunomodulators / Targeted therapy
Time Frame
Day 0
Title
Weight
Description
In kilos
Time Frame
Day 0
Title
Height
Description
In centimeters
Time Frame
Day 0
Title
Body Mass Index
Description
Body Mass Index = kg/m2 where kg is the person's weight in kilograms and m2 is their height in metres squared.
Time Frame
Day 0
Title
Smoking status
Description
Yes/ No < 10 cigarettes per day ≥ 10 cigarettes / day Smoking cessation Yes / No
Time Frame
Day 0
Title
Alcohol use
Description
Yes / No / Withdrawal
Time Frame
Day 0
Title
Charlson score
Description
Mild liver disease: Yes / No Moderate to severe liver disease: Yes / No Cerebrovascular disease (excluding hemiplegia): Yes / No Venous insufficiency of the lower limbs: Yes / No Mesenteric vascular disease: Yes / No Renal artery vascular disease: Yes / No Aortic aneurysm : Yes / No Peptic ulcer disease : Yes / No Chronic lung disease : Yes / No Connectivitis: Yes / No Non-metastatic solid tumor : Yes / No Metastatic solid tumor : Yes / No Leukemia : Yes / No Lymphoma, Myeloma: Yes / No AIDS : Yes / No Organ transplant / Yes / No
Time Frame
Day 0

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sophie SCHULDINER, Dr.
Phone
+334 66 68 33 21
Email
sophie.schuldiner@chu-nimes.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Anissa MEGZARI
Phone
+33466684236
Email
drc@chu-nimes.fr
Facility Information:
Facility Name
Chu de Nimes
City
Nîmes
ZIP/Postal Code
30029
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
CHU DE NIMES
Phone
0466683256
First Name & Middle Initial & Last Name & Degree
Sophie SCHULDINER

12. IPD Sharing Statement

Learn more about this trial

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).

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