The Accuracy of Infrared Thermographic Imaging for Assessment of Periodontal Status

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

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.

Study Overview

• Status: Recruiting
• Conditions: Periodontal Diseases
• Intervention / Treatment: Diagnostic test: infrared thermal camera

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 Type: Observational
• Enrollment (Estimated): 45

Contacts and Locations

• Study Contact: Name: Shrouk N. Elboray, BDS; Phone Number: +0201065433857; Email: shrouk.elboraay@dent.asu.edu.eg
• Study Contact Backup: Name: Mahetab M. AbdalWahab, lecturer; Phone Number: +0201115554490; Email: mahetabmohamed@dent.asu.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • Faculty of Dentistry Ain Shams university
    • Contact: Shrouk N. Elboray, BDS; Phone Number: +201065433857; Email: shrouk.elboraay@dent.asu.edu.eg
    • Contact: Mahetab M. AbdalWahab, lecturer; Phone Number: +201115554490; Email: mahetabmohamed@dent.asu.edu.eg
    • Principal Investigator: Ola M. Ezzatt, professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

A total of 45 of consecutive patients attending the periodontology outpatient clinic Patients will be selected according to the previously mentioned inclusion and exclusion criteria to be examined clinically and thermographically then they will be clustered into 3 clusters gingivitis , periodontitis and healthy patients based on the clinical diagnosis and each cluster will consist of 15 patients .

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determine the agreement of thermographic images for diagnosis of periodontal diseases	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).	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The temperature ranges for healthy periodontium, gingivitis and periodontitis	The temperature ranges for healthy periodontium, and for gingivitis, as well as, for periodontitis will be evaluated.	1 day

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Study Director: Ola M. Ezzatt, professor, Faculty of Dentistry - Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2023
• Primary Completion (Estimated): October 31, 2024
• Study Completion (Estimated): November 30, 2024

Study Registration Dates

• First Submitted: February 25, 2024
• First Submitted That Met QC Criteria: February 29, 2024
• First Posted (Actual): March 4, 2024

Study Record Updates

• Last Update Posted (Actual): August 14, 2024
• Last Update Submitted That Met QC Criteria: August 13, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: periodontal disease; thermography; thermal changes
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Periodontal Diseases
• Other Study ID Numbers: FDASU-Rec IM 112318

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No