Clinical trial NCT06290414: The Accuracy of Infrared Thermographic Imaging for Assessment of Periodontal Status
Official title: The Accuracy of Infrared Thermographic Imaging for Assessment of Periodontal Status (A Cross-Sectional Study )
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Periodontal Diseases
Keywords: thermography
thermal changes
periodontal disease
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2024-03-04
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
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 .

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

Eligibility criteria: 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

Primary outcomes:
measure: Determine the agreement of thermographic images for diagnosis of periodontal diseases
timeFrame: 1 day
Secondary outcomes:
measure: The temperature ranges for healthy periodontium, gingivitis and periodontitis
timeFrame: 1 day
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of dentistry Ain Shams University
Study officials:
affiliation: faculty of dentistry - Ain Shams University
name: Ola M. Ezzatt, professor
role: STUDY_DIRECTOR
References: