Thermography and Burning Mouth Syndrome (TDSBA)

Thermography as a Non-ionizing Quantitative Tool for Diagnosing of Burning Mouth Syndrome

Medical thermography is a noninvasive technique that allows an examiner to visualize and estimate the temperature of the body . This technique allows for an evaluation of the functionality of the structures, which is why it is considered a physiological test and records the variation in the surface temperature of the human body based on the infrared radiation emitted by the surface of that body .Subjects with burning mouth syndrome (BMS) have altered sensitivity and pain thresholds for thermal stimuli compared to a control group An objective of this study is to standardize temperature values derived from thermograms of the tongue in BMS .

Study Overview

• Status: Completed
• Conditions: Burning Mouth Syndrome
• Intervention / Treatment: Device: The objective is to measure the temperature of the lingual dorsum

Detailed Description

An objective of this study is to standardize temperature values derived from thermograms of the tongue in BMS

Subjects will make one visit to our clinic with burning mouth syndrome and control healthy . They will be asked to acclimate to room temperature for at least 20 minutes. Subjects are requested not to consume hot drinks or food for at least an hour before imaging and not to use any skin preparations. During the tests, infrared thermal images were taken immediately after subjects protruded their tongues forward and downward to the desired position

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• Spain
  • Murcia, Spain, 30004
    • Pia Lopez Jornet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Burning mouth syndrome (BMS )patients and control healthy patients

Description

Inclusion Criteria:

• Written informed consent signed he patients were diagnosed with BMS according to the criteria of the International Classification of Headache Disorders

Exclusion Criteria:

• Fibromyalgia
• Fever
• Reflux
• Cancer,
• Oral infection,
• Pregnant or breastfeeding women

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy subjects; The objective is to measure the temperature of the lingual dorsum	Device: The objective is to measure the temperature of the lingual dorsum; Subjects will make one visit to our clinic with burning mouth syndrome and control healthy . They will be asked to acclimate to room temperature for at least 20 minutes. Subjects are requested not to consume hot drinks or food for at least an hour before imaging and not to use any skin preparations.
Burning mouth syndrome; The objective is to measure the temperature of the lingual dorsum	Device: The objective is to measure the temperature of the lingual dorsum; Subjects will make one visit to our clinic with burning mouth syndrome and control healthy . They will be asked to acclimate to room temperature for at least 20 minutes. Subjects are requested not to consume hot drinks or food for at least an hour before imaging and not to use any skin preparations.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of temperature tongue	Tongue temperature areas: tongue tip, middle, left lateral, right lateral,changes in colour pixels will be analysed to determine temperature changes since this is a measurement or diagnostic study using thermographic imagery, there is no health risk to the subjects.	Day 1am . experimental subject and each control subject will be seen once for the administration of the thermography imagery

Collaborators and Investigators

• Sponsor: Universidad de Murcia

Publications and helpful links

General Publications

• Lv C, Wang X, Chen J, Yang N, Fisk I. A non-invasive measurement of tongue surface temperature. Food Res Int. 2019 Feb;116:499-507. doi: 10.1016/j.foodres.2018.08.066. Epub 2018 Aug 25.
• Mo X, Zhang J, Fan Y, Svensson P, Wang K. Thermal and mechanical quantitative sensory testing in Chinese patients with burning mouth syndrome--a probable neuropathic pain condition? J Headache Pain. 2015;16:84. doi: 10.1186/s10194-015-0565-x. Epub 2015 Sep 24.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2022
• Primary Completion (Actual): May 17, 2022
• Study Completion (Actual): May 17, 2022

Study Registration Dates

• First Submitted: May 17, 2022
• First Submitted That Met QC Criteria: May 28, 2022
• First Posted (Actual): June 1, 2022

Study Record Updates

• Last Update Posted (Actual): June 1, 2022
• Last Update Submitted That Met QC Criteria: May 28, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Wounds and Injuries; Disease; Stomatognathic Diseases; Mouth Diseases; Syndrome; Burns; Burning Mouth Syndrome
• Other Study ID Numbers: 3608/2021

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No