Temporomandibular Joint DisorderNCT06874868
Salivary Cortisol As a Biomarker in Patients with Temporomandibular Disorder
An observational study of Temporomandibular Joint Disorder, run by University of Coimbra at 1 site in Portugal.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Temporomandibular Joint Disorder
- How many people
- 50 participants
- Where
- 1 sitePortugal
- Study dates
- 15 Sep 2024to 30 May 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Individuals diagnosed with any form of temporomandibular disorder (TMD) based on the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD).
Who may be able to join
- Patients who attend the dental clinic of the Faculty of Medicine of University of Coimbra
Who cannot join
- Pregnant women, minors and non-autonomous individuals
Trial locations and contacts
1 site in 1 country.
Portugal1 site, 1 recruiting
- Recruiting
Faculty of Medicine of University of Coimbra
Coimbra, Coimbra District, 3000-075
Bruno Macedo, PhD, +351-239 249 151, brunomacsousa@gmail.com
About this study
Official title: Assessment of Salivary Cortisol As a Biomarker in Patients with Temporomandibular Disorder
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.
Read more
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
- Medical subject headings
- Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Case group | Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2025
- Study start15 Sep 2024
- Primary completion20 Sep 2024
- Study completion30 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Temporomandibular Joint DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- University of Coimbra
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bruno Macedo de Sousa, University of Coimbra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06874868
- Sponsor's protocol ID
- FMUCMD2025
- Status last verified
- Sep 2024
- First submitted
- 7 Mar 2025
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41607325
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Salivary Cortisol As a Biomarker in Patients with Temporomandibular Disorder
- ClinicalTrials.gov ID
- NCT06874868
- Acronym / sponsor ID
- FMUCMD2025
- Conditions
- Temporomandibular Joint Disorder
- Keywords
- Temporomandibular disorders, TMD, Cortisol
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of CoimbraUniversity, hospital or other
- Study start
- 15 Sep 2024 (actual)
- Primary completion
- 20 Sep 2024 (actual)
- Study completion
- 30 May 2025 (estimated)
- First posted
- 13 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Case group | – | –Control group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals diagnosed with any form of temporomandibular disorder (TMD) based on the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD).
Key inclusion criteria (1 listed)
- Patients who attend the dental clinic of the Faculty of Medicine of University of Coimbra
Key exclusion criteria (1 listed)
- Pregnant women, minors and non-autonomous individuals
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Salivary cortisol concentration
Time frame: One day
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
- Derived from this study: PubMed 41607325Macedo 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Temporomandibular Joint Disorder, run by University of Coimbra at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bruno Macedo, PhD (+351-239 249 151, brunomacsousa@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Salivary cortisol concentration (time frame: One day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06874868, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2025.