Salivary Cortisol As a Biomarker in Patients with Temporomandibular Disorder

NCT06874868 | Recruiting

• 1 other identifier: FMUCMD2025
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

t is recognized that cortisol, a hormone produced by the adrenal glands, is a marker that is elevated in patients with psychological disorders, particularly anxiety. On the other hand, Temporomandibular Disorders (TMD) are a condition with a multifactorial etiology, in which emotional disturbances play a crucial role. Therefore, the aim of this study is to evaluate whether patients with TMD have higher levels of salivary cortisol compared to the general population. Initially, an assessment will be conducted using the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) protocol to determine whether the patient suffer of any kind of Temporomandibular Disorder. Based on the results, individuals will be classified into two groups: the study group, consisting of patients with TMD, and the control group, composed of individuals without the disorder. Those who agree to participate will be required to sign an informed consent form. Subsequently, a saliva sample will be collected for analysis.

Conditions

Temporomandibular Joint Disorder

Keywords

Temporomandibular disorders; TMD; Cortisol

Outcome Measures

Primary Outcomes (1)

• Salivary cortisol concentration

  The collection should be performed at the time specified by the physician and at least 30 minutes after the ingestion of solid or liquid foods. A collection tube must be obtained from the laboratory, and the following steps should be followed: Remove the smaller tube from the collection kit. Open the tube, take out the swab, and place it in the mouth. Gently chew the swab for approximately 1 minute or until swallowing the accumulated saliva becomes unavoidable. Return the swab to the smaller tube, ensure it is securely sealed, and then place it inside the larger tube. Immediately freeze the sample.

  One day

Study Arms (1)

Case group

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals diagnosed with any form of temporomandibular disorder (TMD) based on the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD).

You may qualify if:

• Patients who attend the dental clinic of the Faculty of Medicine of University of Coimbra

You may not qualify if:

• Pregnant women, minors and non-autonomous individuals

Sponsors & Collaborators

• University of Coimbra: lead

Study Sites (1)

Faculty of Medicine of University of Coimbra

Coimbra, Coimbra District, 3000-075, Portugal

RECRUITING

Related Publications (1)

• Macedo de Sousa B, Lopez-Valverde N, Cardoso C, Lopez-Valverde A, Rodrigues MJ, Blanco Rueda JA. Evaluation of the salivary biomarker cortisol in patients with temporomandibular disorders. J Oral Facial Pain Headache. 2026 Jan;40(1):81-87. doi: 10.22514/jofph.2026.007. Epub 2026 Jan 12.

  PMID: 41607325 DERIVED

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases

Central Study Contacts

Bruno Macedo, PhD

CONTACT

+351-239 249 151; brunomacsousa@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 7, 2025
• First Posted: March 13, 2025
• Study Start: September 15, 2024
• Primary Completion: September 20, 2024
• Study Completion: May 30, 2025
• Last Updated: March 13, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)