The Accuracy of Infrared Thermographic Imaging for Assessment of Periodontal Status

Recruiting

• Conditions: Periodontal Diseases

• Registration Number: NCT06290414
• Lead Sponsor: Ain Shams University

Brief Summary

The diagnosis and differentiation between periodontal diseases are currently based on the measuring and interpretation of full-mouth clinical and radiographic criteria. Thermography is a modern non-invasive imaging method in which the infrared radiation emitted by an object allows the mapping and analysis of the exact temperature distribution on the surface of the object. The produced thermal images correlate with variations in local blood supply and tissue metabolism. Thus, suggested to be a useful rapid and non-invasive tool for the diagnosis of periodontal diseases. However, the validity of this tool compared to standard tools should be evaluated.

Detailed Description

A total of 45 of consecutive patients attending the periodontology outpatient clinic will be examined using standard periodontal clinical parameters including; Plaque index (PI), Gingival index (GI), Probing depth (PD), Clinical attachment level (CAL), and standardized periapical radiograph, to identify patients with gingivitis, periodontitis, or healthy periodontium , these 45 patients will be clustered into 3 clusters consisting of 15 patients each to represent each category. The same patients will be examined using an infrared thermal camera (Fluke PTi120 Pocket Thermal Imager), the settings will be all according to the standards of infrared medical diagnosis then the acquired images will be analyzed with (Fluke SmartView IR Analysis Reporting Software and Mobile Application). The images will be interpreted to detect the temperature changes in each mm in tissues in order to determine the patients with gingivitis, periodontitis, or healthy periodontium by an investigator blinded to clinical diagnosis. Then the diagnostic sensitivity and specificity of thermographic images for diagnosis of periodontal diseases will be calculated

Study Timeline

• Study Start: 2023-11-30
• Study First Submitted: 2024-02-25
• Study First Submitted QC: 2024-02-29
• Study First Posted: 2024-03-04
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-13
• Last Update Posted: 2024-08-14
• Primary Completion: 2024-10-31
• Study Completion: 2024-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• The patients will be enrolled into the study based on the following inclusion criteria:

  1. Patients with generalized gingivitis
  2. patient with generalized periodontitis .
  3. patient with healthy periodontium .
  4. Both genders above 18 y to 60 y .

Exclusion Criteria

• The patients will not be enrolled into this study based on the following exclusion criteria:

  1. pregnant women .

  2. smokers .

  3. Patients on medications that cause xerostomia as diuretics , antidepressants

     ,bronchodilators ,antihistaminics , antiepileptic ( etc ..)

  4. Patient using antibiotic, anti-inflammatory, and immunosuppressive therapy during the during the study .

  5. molars according to camera specifications

  6. handicapped patients

  7. para functional habits as mouth breathing and tongue thrusting

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Determine the agreement of thermographic images for diagnosis of periodontal diseases	1 day	Determine the agreement of thermographic images for diagnosis of periodontal diseases through the following outcomes: * Sensitivity The proportion of true positives in diseased subjects= True positives/ (true positives + false negatives); * Specificity The proportion of true negatives in non-diseased subjects= True negatives/ (true negatives + false positives).

Secondary Outcome Measures

Name	Time	Method
The temperature ranges for healthy periodontium, gingivitis and periodontitis	1 day	The temperature ranges for healthy periodontium, and for gingivitis, as well as, for periodontitis will be evaluated.

Trial Locations

Locations (1)

Faculty of dentistry Ain Shams University; 🇪🇬 Cairo, Egypt