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Completed

NCT Number: 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).

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chu de Nimes

Nîmes, 30029, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Front view photography of the patient's oral cavity with the help of a smartphone in the diabetology department.

Diagnostic Test

The diabetologist will take a photograph of the patient's oral cavity in the diabetology department.

Primary outcomes

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

    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.

  2. Parodontitis based on clinical observation of the patient's oral cavity (direct method)

    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.

Secondary outcomes

  1. A. Sensitivity and specificity of the Positive Predictive Value (NPV) measured by the indirect method

    Time frame: Day 0 to day 7

    Positive predictive value = True Positive / (True Positives+False Positives)

  2. A. Sensitivity and specificity of the Negative Predictive Value (NPV) measured by the indirect method

    Time frame: Day 0 to day 7

    Negative predictive value = True Negative / (False Negatives + True Negatives)

  3. A. Sensitivity and specificity of the Positive Predictive Value (PPV) measured by the direct method

    Time frame: Day 0

    Positive predictive value = True Positive / (True Positives+False Positives)

  4. A. Sensitivity and specificity of the Positive Predictive Value (PPV) measured by the indirect method

    Time frame: Day 0 to day 7

    Negative predictive value = True Negative / (False Negatives+True Negatives)

  5. B. Quality of photographs taken by the diabetology department : respect of anonymity

    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).

  6. B. Quality of photographs taken by the diabetology department : visibility of the gums

    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.

  7. B. Quality of photographs taken by the diabetology department : image sharpness

    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

  8. B. Quality of photographs taken by the diabetology department : use of the flash

    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

  9. B. Quality of photographs taken by the diabetology department : absence of zoom

    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

  10. B. Quality of photographs taken by the diabetology department : orientation

    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

  11. B. Percentage of photographs meeting all of the above criteria for acceptance

    Time frame: Day 0 to day 7

    The number of photographs that meet all the above acceptance criteria will be converted into a percentage.

  12. C. Association between the patient's diabetic constants and his/her periodontal status. Hospitalization

    Time frame: Day 0

    Diabetic findings according to the following criteria recorded for each patient included:

    • the type of hospitalization (day or week)
  13. C. Association between the patient's diabetic constants and his/her periodontal status. Type of diabetes

    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)

  14. C. Association between the patient's diabetic constants and his/her periodontal status. Age of diabetes

    Time frame: Day 0

    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
  15. C. Association between the patient's diabetic constants and his/her periodontal status. Treatment

    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.

  16. C. Association between the patient's diabetic constants and his/her periodontal status.HbA1c level

    Time frame: Day 0

    Diabetic findings according to the following criteria recorded for each patient included:

    • the patient's HbA1c level will be recorded in mmol/mol
  17. C. Association between the patient's diabetic constants and his/her periodontal status. Macrovascular complications

    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

  18. C. Association between the patient's diabetic constants and his/her periodontal status. Type of macrovascular complication

    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

  19. C. Association between the patient's diabetic constants and his/her periodontal status. Microvascular complications

    Time frame: Day 0

    Diabetic findings according to the following criteria recorded for each patient included:

    -presence of microvascular complications, YES/NO

  20. C. Association between the patient's diabetic constants and his/her periodontal status. Type of microvascular complication

    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

  21. C. Association between the patient's diabetic constants and his/her periodontal status. Smoking

    Time frame: Day 0

    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
  22. C. Association between the patient's diabetic constants and his/her periodontal status. Periodontitis

    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.

  23. D. Visible clinical signs associated with periodontitis on the photos taken. Inflammation

    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.

  24. D. Visible clinical signs associated with periodontitis on the photos taken. Root tartar

    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.

  25. D. Visible clinical signs associated with periodontitis on the photos taken. Pus

    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.

  26. D. Visible clinical signs associated with periodontitis on the photos taken. Bleeding

    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.

  27. D. Visible clinical signs associated with periodontitis on the photos taken. Interdental space

    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.

  28. D. Visible clinical signs associated with periodontitis on the photos taken. Gum retraction

    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.

  29. D. Visible clinical signs associated with periodontitis on the photos taken. Swollen gums

    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.

  30. D. Visible clinical signs associated with periodontitis on the photos taken. Plaque

    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.

Other outcomes

  1. Sex of patients

    Time frame: Day 0

    Male/female

  2. Age of patients

    Time frame: Day 0

    In years

  3. Type of hospitalization

    Time frame: Day 0

    Inpatients/Outpatients

  4. Periodontal status

    Time frame: Day 0

    Periodontitis / gingivitis / healthy

  5. Lifestyle

    Time frame: Day 0

    Lives alone / Lives with family or nearby / Homeless

  6. Level of education

    Time frame: Day 0

    Primary / Secondary / Graduate / Post-graduate

  7. Professional activity

    Time frame: Day 0

    Employed / Full-time/ Part-time/ Unemployed

  8. Type of diabetes

    Time frame: Day 0

    Type 1 / Type 2 / Unknown / Other

  9. Diabetic for how long

    Time frame: Day 0

    More than 20 years / 10 to 20 years / 5 to 10 years / Less than 5 years / Unknown

  10. Presence of microangiopathic complications

    Time frame: Day 0

    YES / NO

  11. Presence of retinopathy

    Time frame: Day 0

    YES / NO / Don't know

  12. Presence of nephropathy

    Time frame: Day 0

    YES / NO / Don't know

  13. Presence of peripheral neuropathy

    Time frame: Day 0

    YES / NO / Don't know

  14. Glomerular filtration rate (GFR)

    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

  15. Dialysis

    Time frame: Day 0

    YES / NO

  16. Presence of macroangiopathic complications

    Time frame: Day 0

    YES / NO

  17. Presence of obliterative arteritis of the lower limbs

    Time frame: Day 0

    YES / NO / Don't know

  18. Presence of supra-aortic arterial trunk disease

    Time frame: Day 0

    YES / NO / Don't know

  19. Presence of coronary artery disease

    Time frame: Day 0

    YES / NO / Don't know

  20. Oral treatment for diabetes

    Time frame: Day 0

    Biguanides / Glucose-lowering sulfonamides / Glinides / Dipeptidyl Peptidase-IV / A-glucosidase inhibitors / SGLT2 inhibitors / None

  21. Injectable antidiabetic treatment

    Time frame: Day 0

    Fast/ultra-fast insulin / Slow/ultra-slow insulin / GLP1 analogues / none

  22. Other treatments

    Time frame: Day 0

    Yes / No If yes specify: Corticosteroids / Chemotherapy / Immunosuppressors / Immunomodulators / Targeted therapy

  23. Weight

    Time frame: Day 0

    In kilos

  24. Height

    Time frame: Day 0

    In centimeters

  25. Body Mass Index

    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.

  26. Smoking status

    Time frame: Day 0

    Yes/ No < 10 cigarettes per day

    ≥ 10 cigarettes / day Smoking cessation Yes / No

  27. Alcohol use

    Time frame: Day 0

    Yes / No / Withdrawal

  28. Charlson score

    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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study 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).

Acronym: PARODIABNOSTIC

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 6, 2023
Registry last updated
Mar 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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