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临床试验/NCT06290414
NCT06290414招募中不适用

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

Ain Shams University1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2023年11月30日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
45
试验地点
1
主要终点
Determine the agreement of thermographic images for diagnosis of periodontal diseases

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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 .

排除标准

  • The patients will not be enrolled into this study based on the following exclusion criteria:
  • pregnant women .
  • 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

结局指标

主要结局

Determine the agreement of thermographic images for diagnosis of periodontal diseases

时间窗: 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).

次要结局

  • The temperature ranges for healthy periodontium, gingivitis and periodontitis(1 day)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Shrouk Nabil

Principal Investigator

Ain Shams University

研究点 (1)

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