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IRCT20181130041806N1 IRCT 2020-06-20 Tehran University of Medical Sciences The accuracy of non-invasive method of oral cancer diagnosis based on the difference in temperature using IR sensor The accuracy of non-invasive method of oral squamous cell cancer diagnosis based on the difference in temperature using IR sensor 2016-10-22 anticipated 20 Complete https://irct.ir/trial/36478 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Diagnostic. N/A Oral squamous cell carcinoma. Intervention 1: Intervention group:The inclusion criteria were selected after searching the scientific literature and consulting oral medicine specialists and oncologists. The inclusion criteria for patients included all patients with OSCC presenting to the Cancer Institute of Imam Khomeini Hospital who were older than 10 years of age. Patients had to be able to understand the prescriptions given and had to be willing to participate in the study. Those with a history of oral surgery, chemotherapy and radiotherapy of the head and neck were not included. Acute infections, diseases of sweat glands such as ectodermal dysplasia, recurrent oral cancer and hyperthermia at the time of examination were exclusion criteria; Also, Patients who did not resume their treatment or presented to other medical centers to resume their treatment and those who did not consent to undergo diagnostic procedures such as biopsy, and those who met the inclusion criteria but underwent surgery or initiated their radiotherapy prior to the onset of study were excluded as well. an intraoral device with temperature-sensitive sensor was used to accurately assess heat distribution and non-invasively detect OSCC based on the thermal difference between the healthy and tumoral tissues.The device has been designed with a small flexible head that can be used intraorally with easily access all areas in the oral cavity which is an advantage because the currently available thermographic devices that are used for cancer detection in other parts of body cannot be used intraorally. This device has high accuracy and records the temperature with 0.02°C accuracy and displays it on a monitor. Also, the device is equipped with an alert system, which beeps when the temperature of an area is higher than the defined normal oral temperature (38.1°C). The device has been designed according to the ergonomic dental principles and is easy to use for the clinicians. Also, it is portable and wireless and can be used anywhere without requiring a camera, a laptop or any other device. For the purpose of standardization, the participants were asked to refrain from eating, drinking and smoking for 30 minutes prior to testing. Also, in order to stabilize the metabolic activity of the human body, the participants were requested to sit in an upright position, in a well-lit room with optimal temperature and humidity for 20 minutes and relax. First, the body temperature was measured by an individual intraoral conventional mercury thermometer and recorded. Next, the patients were requested to slightly tilt their head backward while in a seated position. The device was then turned on and the sensor was held at a close distance from the approximate center of lesion, which according to the literature, has the highest temperature for about 30 seconds until the temperature displayed on the monitor stabilized. This value indicated the mean temperature of the lesion. The same was done for the contra-lateral healthy mucosa of the same patient, and the temperature was recorded as the control temperature. For the purpose of infection control, the tip of the device covered with disposable covers and changed for each patient. Temperature measurements were made by an expert oral medicine specialist who had been trained to use this device. Next, according to the opinion of an oncologist, all patients underwent incisional biopsy, which is the gold standard for detection of oral lesions. Intervention 2: Control group: The inclusion criteria for the control group were healthy individuals with no oral lesion and older than 10 years of age and had to be able to understand the prescriptions given and had to be willing to participate in the study. Those with a history of oral surgery, chemotherapy and radiotherapy of the head and neck were not included. Acute infections, diseases of sweat glands such as ectodermal dysplasia, oral cancer and hyperthermia at the time of examination were exclusion criteria.Since, the higher number of patients had OSCC of tongue compared with whom had OSCC of lips (4 to 1), in the next step the temperature of the lateral sides of the tongue (right and left) in 10 healthy controls was measured as explained in patient group. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is hh The study is trying to patent the device used and it is not clear how long the patent will last.
public Shahrzad Rahimizadeh Nahavandi
No 10, 3rd Noorafshar St., Jamalabad Ave., Niavaran Ave
Tehran Iran (Islamic Republic of) 1978735674 +98 21 2282 7955 Shahrzad.rahimizadeh@gmail.com Tehran University of Medical Sciences scientific Shahrzad Rahimizadeh Nahavandi
No 10, 3rd Noorafshar St., Jamalabad Ave., Niavaran Ave
Tehran Iran (Islamic Republic of) 1978735674 +98 21 2282 7955 Shahrzad.rahimizadeh@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) In the experimental group, all patients with oral squamous cell carcinoma referring to Cancer Institute of Imam Khomeini Hospital greater than 10 years old In the control group, all healthy subjects without oral lesions greater than 10 years old 10 years no limit Both Having acute infectious diseases or sweat glands diseases such as Ectodermal Dysplasia Hyperthermia History of oral cancer in the same area (recurrent oral lesion) C06.9 Malignant neoplasm of mouth, unspecified Early detection Early detection Intervention group:The inclusion criteria were selected after searching the scientific literature and consulting oral medicine specialists and oncologists. The inclusion criteria for patients included all patients with OSCC presenting to the Cancer Institute of Imam Khomeini Hospital who were older than 10 years of age. Patients had to be able to understand the prescriptions given and had to be willing to participate in the study. Those with a history of oral surgery, chemotherapy and radiotherapy of the head and neck were not included. Acute infections, diseases of sweat glands such as ectodermal dysplasia, recurrent oral cancer and hyperthermia at the time of examination were exclusion criteria; Also, Patients who did not resume their treatment or presented to other medical centers to resume their treatment and those who did not consent to undergo diagnostic procedures such as biopsy, and those who met the inclusion criteria but underwent surgery or initiated their radiotherapy prior to the onset of study were excluded as well. an intraoral device with temperature-sensitive sensor was used to accurately assess heat distribution and non-invasively detect OSCC based on the thermal difference between the healthy and tumoral tissues.The device has been designed with a small flexible head that can be used intraorally with easily access all areas in the oral cavity which is an advantage because the currently available thermographic devices that are used for cancer detection in other parts of body cannot be used intraorally. This device has high accuracy and records the temperature with 0.02°C accuracy and displays it on a monitor. Also, the device is equipped with an alert system, which beeps when the temperature of an area is higher than the defined normal oral temperature (38.1°C). The device has been designed according to the ergonomic dental principles and is easy to use for the clinicians. Also, it is portable and wireless and can be used anywhere without requiring a camera, a laptop or any other device. For the purpose of standardization, the participants were asked to refrain from eating, drinking and smoking for 30 minutes prior to testing. Also, in order to stabilize the metabolic activity of the human body, the participants were requested to sit in an upright position, in a well-lit room with optimal temperature and humidity for 20 minutes and relax. First, the body temperature was measured by an individual intraoral conventional mercury thermometer and recorded. Next, the patients were requested to slightly tilt their head backward while in a seated position. The device was then turned on and the sensor was held at a close distance from the approximate center of lesion, which according to the literature, has the highest temperature for about 30 seconds until the temperature displayed on the monitor stabilized. This value indicated the mean temperature of the lesion. The same was done for the contra-lateral healthy mucosa of the same patient, and the temperature was recorded as the control temperature. For the purpose of infection control, the tip of the device covered with disposable covers and changed for each patient. Temperature measurements were made by an expert oral medicine specialist who had been trained to use this device. Next, according to the opinion of an oncologist, all patients underwent incisional biopsy, which is the gold standard for detection of oral lesions Control group: The inclusion criteria for the control group were healthy individuals with no oral lesion and older than 10 years of age and had to be able to understand the prescriptions given and had to be willing to participate in the study. Those with a history of oral surgery, chemotherapy and radiotherapy of the head and neck were not included. Acute infections, diseases of sweat glands such as ectodermal dysplasia, oral cancer and hyperthermia at the time of examination were exclusion criteria.Since, the higher number of patients had OSCC of tongue compared with whom had OSCC of lips (4 to 1), in the next step the temperature of the lateral sides of the tongue (right and left) in 10 healthy controls was measured as explained in patient group. The temperature difference between the healthy area and the area with oral squamous cell carcinoma. Timepoint: At the beginning of the study before the biopsy. Method of measurement: Infrared sensor. Researcher Approved 2016-08-21 Ethics committee of Tehran University of Medical Sciences Central of Tehran University of Medical Sciences, Qods St., Keshavarz Blvd. Tehran Tehran Iran (Islamic Republic of)