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NCT Number: NCT06290414

The Accuracy of Infrared Thermographic Imaging for Assessment of Periodontal Status

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • The patients will be enrolled into the study based on the following inclusion criteria:
  • Patients with generalized gingivitis
  • patient with generalized periodontitis .
  • patient with healthy periodontium .
  • 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:
  • pregnant women .
  • smokers .
  • Patients on medications that cause xerostomia as diuretics , antidepressants

,bronchodilators ,antihistaminics , antiepileptic ( etc ..)

  • Patient using antibiotic, anti-inflammatory, and immunosuppressive therapy during the during the study .
  • molars according to camera specifications
  • handicapped patients
  • para functional habits as mouth breathing and tongue thrusting

Treatment and study plan

infrared thermal camera

Diagnostic Test

capturing thermographic imaging of gingiva to detect thermal changes due to inflammation as a result of periodontal disease

Primary outcomes

  1. Determine the agreement of thermographic images for diagnosis of periodontal diseases

    Time frame: 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 outcomes

  1. The temperature ranges for healthy periodontium, gingivitis and periodontitis

    Time frame: 1 day

    The temperature ranges for healthy periodontium, and for gingivitis, as well as, for periodontitis will be evaluated.

Study contacts

Contact information is provided by the study sponsor or research team.

Mahetab M. AbdalWahab, lecturer

CONTACT

[email protected]

+0201115554490

Shrouk N. Elboray, BDS

CONTACT

[email protected]

+0201065433857

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

The Accuracy of Infrared Thermographic Imaging for Assessment of Periodontal Status (A Cross-Sectional Study )

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 4, 2024
Registry last updated
Aug 14, 2024

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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