FMRI Study on DC/TMD Patients

November 27, 2025 updated by: Marco Farronato, University of Milan

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Gianluca Tartaglia GMT Tartaglia
  • Phone Number: +39 02 5032 5032
  • Email: gio.cat@hotmail.it

Study Locations

  • Italy
      • Milan, Italy
        • University of Milan
        • Contact:
        • Sub-Investigator:
          • Marco Farronato, DDS; PhD
        • Sub-Investigator:
          • Giovanni Cattaneo, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: study
FMRI
Diagnostic test: fMRI
fMRI morphological analysis
Active Comparator: Healthy controls
FMRI
Diagnostic test: fMRI
fMRI morphological analysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
end of the fmri

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Milan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2026

Primary Completion (Estimated)

January 1, 2030

Study Completion (Estimated)

January 1, 2031

Study Registration Dates

First Submitted

September 30, 2025

First Submitted That Met QC Criteria

November 27, 2025

First Posted (Actual)

December 2, 2025

Study Record Updates

Last Update Posted (Actual)

December 2, 2025

Last Update Submitted That Met QC Criteria

November 27, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DC/TMD01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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