NCT05399238

Brief 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 .

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2022

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

May 17, 2022

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 17, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 17, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 1, 2022

Completed
Last Updated

June 1, 2022

Status Verified

May 1, 2022

Enrollment Period

16 days

First QC Date

May 17, 2022

Last Update Submit

May 28, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

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

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

Interventions

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 syndromeHealthy subjects

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Burning mouth syndrome (BMS )patients and control healthy patients

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pia Lopez Jornet

Murcia, 30004, Spain

Location

Related 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.

    PMID: 30716974BACKGROUND
  • 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.

    PMID: 26399417BACKGROUND

MeSH Terms

Conditions

Burning Mouth Syndrome

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director Oral Medicine

Study Record Dates

First Submitted

May 17, 2022

First Posted

June 1, 2022

Study Start

May 1, 2022

Primary Completion

May 17, 2022

Study Completion

May 17, 2022

Last Updated

June 1, 2022

Record last verified: 2022-05

Locations