FMRI Study on DC/TMD Patients

NCT ID: NCT07259902

Last Updated: 2025-12-02

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-01
• Study Completion Date: 2031-01-01

Brief Summary

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.

Conditions

TMJ Disorder

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

study

FMRI

Group Type: EXPERIMENTAL

fMRI

Intervention Type: DIAGNOSTIC_TEST

fMRI morphological analysis

Healthy controls

FMRI

Group Type: ACTIVE_COMPARATOR

fMRI

Intervention Type: DIAGNOSTIC_TEST

fMRI morphological analysis

Interventions

fMRI

fMRI morphological analysis

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Healthy subjects defined as free from temporomandibular disorders or diagnosed psychological and/or psychiatric disorders.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Milan

OTHER

Sponsor Role: lead

Responsible Party

Marco Farronato

CO-Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Milan

Milan, , Italy

Countries

Italy

Central Contacts

Gianluca Tartaglia GMT Tartaglia

Role: CONTACT

gio.cat@hotmail.it

+39 02 5032 5032

Facility Contacts

Gianluca M Tartaglia

Role: primary

gio.cat@hotmail.it

+39 02 5032 5032

Other Identifiers

DC/TMD01

Identifier Type: -

Identifier Source: org_study_id