An observational study in Periodontal Diseases, sponsored by Ain Shams University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-14.
Sponsored by Ain Shams University · Observational
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.
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
830 studies on the registry are indexed under Periodontal Diseases; 188 are open to participants now.
This study's planned enrollment of 45 is below the median of 100 across 291 observational studies indexed under Periodontal Diseases.
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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 .
The patients will be enrolled into the study based on the following inclusion criteria:
Exclusion Criteria:
The patients will not be enrolled into this study based on the following exclusion criteria:
Patients on medications that cause xerostomia as diuretics , antidepressants
,bronchodilators ,antihistaminics , antiepileptic ( etc ..)
capturing thermographic imaging of gingiva to detect thermal changes due to inflammation as a result of periodontal disease
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).
Time frame: 1 day
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.
Time frame: 1 day
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Ain Shams University