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NCT Number: NCT07259902

FMRI Study on DC/TMD Patients

Temporomandibular disorders (TMD) are among the most common causes of chronic pain worldwide. It is estimated that about 5-12% of the global population is affected, and some conditions, such as arthritis, may be causative factors. Depending on severity, the joints involved can affect multiple functions of the masticatory system, such as the ability to speak, chew, swallow, limit facial expressions, and even breathe. Moreover, most patients with TMD may report painful conditions in other parts of the body, with comorbidities including chronic fatigue syndrome, chronic headache, endometriosis, fibromyalgia, interstitial cystitis, irritable bowel syndrome, back pain, sleep disorders, and vulvodynia. Another significant condition that frequently occurs alongside TMD is psychological distress in the form of anxiety and/or depression.

The study proposed by this research protocol aims to investigate the presence of TMD and associated psychological/psychiatric disorders such as anxiety and depression. The innovative value of the research lies in evaluating whether the association between these disorders may lead to neuroplastic changes at the brain level, which could guide targeted therapies. Only a few studies in the literature have explored this possible association, with inconclusive and conflicting results.

The study will be prospective in design, based on reference clinical/diagnostic criteria and functional neuroimaging.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Milan

Milan, Italy

Location contact

Gianluca M Tartaglia

CONTACT

[email protected]

+39 02 5032 5032

Giovanni Cattaneo, MD

SUB_INVESTIGATOR

Marco Farronato, DDS; PhD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Afflicted with temporomandibular disorder (TMD) associated with chronic pain diagnosed by an experienced specialist among the authors; the disorder, to be considered chronic, must have been present for at least six months.
  • Patients with adequate sensorimotor abilities to participate in the study. This included sufficient vision to read from a computer or tablet screen at a normal distance, sufficient hearing ability to understand normal language, and sufficient motor ability to control a table mouse or computer.

Exclusion criteria

  • Control subjects, participating voluntarily in the study, must have met the following inclusion criteria:
  • Healthy subjects defined as free from temporomandibular disorders or diagnosed psychological and/or psychiatric disorders.

Treatment and study plan

fMRI

Diagnostic Test

fMRI morphological analysis

Primary outcomes

  1. fmri Blood Oxygen Level-Dependent (BOLD)

    Time frame: end of the fmri

    Oxygenation concentration (referred to as BOLD). Bold is primarily used on the other hand to conduct function brain mapping. The degree of BOLD is a measure of the neuronal activity.

Study contacts

Contact information is provided by the study sponsor or research team.

Gianluca Tartaglia GMT Tartaglia

CONTACT

[email protected]

+39 02 5032 5032

Sponsors and collaborators

Lead sponsor

University of Milan

Other

Registry information

Official study title

Mapping the Neuroplasticity of Patients Affected by Chronic Temporomandibular Disorders on fMRI

Important dates

Study start
2026
Primary completion
2030
Study completion
2031
First posted
Dec 2, 2025
Registry last updated
Dec 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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