Burning Mouth SyndromeTDSBANCT05399238
Thermography and Burning Mouth Syndrome
An observational study of Burning Mouth Syndrome, run by Universidad de Murcia at 1 site in Spain.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Burning Mouth Syndrome
- What is being tested?
- The objective is to measure the temperature of the lingual dorsum
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 1 May 2022to 17 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Burning mouth syndrome (BMS )patients and control healthy patients
Who may be able to join
- Written informed consent signed he patients were diagnosed with BMS according to the criteria of the International Classification of Headache Disorders
Who cannot join
- Fibromyalgia
- Fever
- Reflux
- Cancer,
- Oral infection,
- Pregnant or breastfeeding women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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 .
Read the 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
- Conditions
- Burning Mouth Syndrome
- Being tested
- The objective is to measure the temperature of the lingual dorsum
- Medical subject headings
- Burning Mouth Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The objective is to measure the temperature of the lingual dorsumDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Healthy subjects | The objective is to measure the temperature of the lingual dorsum Receives: Device: The objective is to measure the temperature of the lingual dorsum | |
| Burning mouth syndrome | The objective is to measure the temperature of the lingual dorsum Receives: Device: The objective is to measure the temperature of the lingual dorsum |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1am . experimental subject and each control subject will be seen once for the administration of the thermography imagery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2022
- Study start1 May 2022
- Primary completion17 May 2022
- Study completion17 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Burning Mouth SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pia Lopez Jornet, Universidad de Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05399238
- Sponsor's protocol ID
- 3608/2021
- Acronym
- TDSBA
- Status last verified
- May 2022
- First submitted
- 17 May 2022
- Last updated
- 1 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 30716974Mo 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.
PubMed 26399417
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thermography as a Non-ionizing Quantitative Tool for Diagnosing of Burning Mouth Syndrome
- ClinicalTrials.gov ID
- NCT05399238
- Acronym / sponsor ID
- TDSBA / 3608/2021
- Conditions
- Burning Mouth Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Universidad de MurciaUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 17 May 2022 (actual)
- Study completion
- 17 May 2022 (actual)
- First posted
- 1 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy subjects | – | Device: The objective is to measure the temperature of the lingual dorsumThe objective is to measure the temperature of the lingual dorsum |
| Burning mouth syndrome | – | Device: The objective is to measure the temperature of the lingual dorsumThe objective is to measure the temperature of the lingual dorsum |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Burning mouth syndrome (BMS )patients and control healthy patients
Key inclusion criteria (1 listed)
- Written informed consent signed he patients were diagnosed with BMS according to the criteria of the International Classification of Headache Disorders
Key exclusion criteria (6 listed)
- Fibromyalgia
- Fever
- Reflux
- Cancer,
- Oral infection,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The objective is to measure the temperature of the lingual dorsumSubjects 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. | Device | Burning mouth syndrome, Healthy subjects |
Primary outcome
Measurement of temperature tongue
Time frame: Day 1am . experimental subject and each control subject will be seen once for the administration of the thermography imagery
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2022.
- Background: PubMed 30716974Lv 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.
- Background: PubMed 26399417Mo 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Burning Mouth Syndrome, run by Universidad de Murcia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of temperature tongue (time frame: Day 1am . experimental subject and each control subject will be seen once for the administration of the thermography imagery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05399238, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2022.