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).

NCT05890807 | Completed

• 1 other identifier: 2022-A02129-34
• Study Type: interventional
• Target: 145
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Complications; Periodontal Diseases

Keywords

Diabetes; Periodontitis

Outcome Measures

Primary Outcomes (2)

• 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.

  Day 0 to day 7

• 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.

  Day 0

Secondary Outcomes (30)

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

  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

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

  Day 0 to day 7

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

  Day 0 to day 7

Other Outcomes (28)

• Sex of patients

  Day 0

• Age of patients

  Day 0

• Type of hospitalization

  Day 0

Study Arms (1)

Patients whose oral cavity will be photographed in the diabetology department

EXPERIMENTAL

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.

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

Interventions

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.

Patients whose oral cavity will be photographed in the diabetology department

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 under court protection, guardianship, or conservatorship.
• Patient for whom informed information cannot be provided.
• Patient who is pregnant or breastfeeding.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

Chu de Nimes

Nîmes, 30029, France

Location

MeSH Terms

Conditions

Diabetes Complications; Periodontal Diseases; Diabetes Mellitus; Periodontitis

Condition Hierarchy (Ancestors)

Endocrine System Diseases; Mouth Diseases; Stomatognathic Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A prospective, single-center, open-label, cross-sectional study to evaluate the concordance of an intervention versus the "gold standard.

Study Record Dates

• First Submitted: May 15, 2023
• First Posted: June 6, 2023
• Study Start: March 20, 2023
• Primary Completion: February 29, 2024
• Study Completion: December 31, 2024
• Last Updated: March 7, 2025

Record last verified: 2025-03

Locations

FR (1)