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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05399238
Other study ID # 3608/2021
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 1, 2022
Est. completion date May 17, 2022

Study information

Verified date May 2022
Source Universidad de Murcia
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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 .


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


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date May 17, 2022
Est. primary completion date May 17, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Spain Pia Lopez Jornet Murcia

Sponsors (1)

Lead Sponsor Collaborator
Universidad de Murcia

Country where clinical trial is conducted

Spain, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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