The Accuracy of Infrared Thermographic Imaging for Assessment of Periodontal Status

Periodontal Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06290414
• Other study ID #: FDASU-Rec IM 112318
• Status: Recruiting
• Start date: November 30, 2023
• Est. completion date: July 30, 2024

Study information

• Verified date: February 2024
• Source: Ain Shams University
• Contact: Shrouk N. Elboray, BDS
• Phone: +0201065433857
• Email: shrouk.elboraay[@]dent.asu.edu.eg
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: July 30, 2024
• Est. primary completion date: March 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Periodontal Diseases

Intervention

Diagnostic Test:
• infrared thermal camera
capturing thermographic imaging of gingiva to detect thermal changes due to inflammation as a result of periodontal disease

Locations

Country	Name	City	State
Egypt	Faculty of dentistry Ain Shams University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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