Chu de Nimes
Nîmes, 30029, France
NCT Number: NCT05890807
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Nîmes, 30029, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The diabetologist will take a photograph of the patient's oral cavity in the diabetology department.
Time frame: 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.
Time frame: 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.
Time frame: Day 0 to day 7
Positive predictive value = True Positive / (True Positives+False Positives)
Time frame: Day 0 to day 7
Negative predictive value = True Negative / (False Negatives + True Negatives)
Time frame: Day 0
Positive predictive value = True Positive / (True Positives+False Positives)
Time frame: Day 0 to day 7
Negative predictive value = True Negative / (False Negatives+True Negatives)
Time frame: Day 0 to day 7
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 to day 7
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 to day 7
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 to day 7
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 to day 7
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 to day 7
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 to day 7
The number of photographs that meet all the above acceptance criteria will be converted into a percentage.
Time frame: Day 0
Diabetic findings according to the following criteria recorded for each patient included:
Time frame: Day 0
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
Diabetic findings according to the following criteria recorded for each patient included:
Time frame: Day 0
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
Diabetic findings according to the following criteria recorded for each patient included:
Time frame: Day 0
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
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
Diabetic findings according to the following criteria recorded for each patient included:
-presence of microvascular complications, YES/NO
Time frame: Day 0
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
Diabetic findings according to the following criteria recorded for each patient included:
Time frame: Day 0
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 to day 7
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 to day 7
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 to day 7
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 to day 7
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 to day 7
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 to day 7
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 to day 7
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 to day 7
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
Male/female
Time frame: Day 0
In years
Time frame: Day 0
Inpatients/Outpatients
Time frame: Day 0
Periodontitis / gingivitis / healthy
Time frame: Day 0
Lives alone / Lives with family or nearby / Homeless
Time frame: Day 0
Primary / Secondary / Graduate / Post-graduate
Time frame: Day 0
Employed / Full-time/ Part-time/ Unemployed
Time frame: Day 0
Type 1 / Type 2 / Unknown / Other
Time frame: Day 0
More than 20 years / 10 to 20 years / 5 to 10 years / Less than 5 years / Unknown
Time frame: Day 0
YES / NO
Time frame: Day 0
YES / NO / Don't know
Time frame: Day 0
YES / NO / Don't know
Time frame: Day 0
YES / NO / Don't know
Time frame: Day 0
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
YES / NO
Time frame: Day 0
YES / NO
Time frame: Day 0
YES / NO / Don't know
Time frame: Day 0
YES / NO / Don't know
Time frame: Day 0
YES / NO / Don't know
Time frame: Day 0
Biguanides / Glucose-lowering sulfonamides / Glinides / Dipeptidyl Peptidase-IV / A-glucosidase inhibitors / SGLT2 inhibitors / None
Time frame: Day 0
Fast/ultra-fast insulin / Slow/ultra-slow insulin / GLP1 analogues / none
Time frame: Day 0
Yes / No If yes specify: Corticosteroids / Chemotherapy / Immunosuppressors / Immunomodulators / Targeted therapy
Time frame: Day 0
In kilos
Time frame: Day 0
In centimeters
Time frame: Day 0
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
Yes/ No < 10 cigarettes per day
≥ 10 cigarettes / day Smoking cessation Yes / No
Time frame: Day 0
Yes / No / Withdrawal
Time frame: Day 0
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
Centre Hospitalier Universitaire de Nīmes
Other
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).
Acronym: PARODIABNOSTIC
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