TMD/Orofacial PainNCT06994156
Diagnostic and Prognostic Salivary Biomarkers in Chronic Muscle Pain
An observational study of TMD/Orofacial Pain and Fibromyalgia (FM), run by Karolinska Institutet at 1 site in Sweden.
Trial summary
A large proportion of the adult population worldwide currently lives with chronic muscle pain, with more than half of those affected experiencing pain localized to the face and jaw. This means that approximately 10-15% of the adult population is affected. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- TMD/Orofacial Pain, Fibromyalgia (FM)
- How many people
- 160 participants
- Where
- 1 siteSweden
- Study dates
- 1 Sep 2023to 1 Jan 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants will be recruited through advertisement and from patients referred to the specialist clinic for orofacial pain and jaw function at the University Dental Clinic at Karolinska Institute (Huddinge, Sweden) and at Eastman Institutet, Folktandvården Stockholm.
Who may be able to join
- Diagnosis of myalgia or myofascial pain with referral according to the DC/TMD Axis I
- Diagnosis of fibromyalgia according to ACR 1990 or ACR 2016 criteria
- Minimum pain intensity of 30 on a 100 mm visual analogue scale (VAS)
Who cannot join
- Diagnosed systemic muscular or joint diseases (except for fibromyalgia)
- Whiplash-associated disorder
- Migraine
- Neurological disorders
- Neuropsychiatric disorders
- Diseases of the salivary glands (e.g., sialadenitis, salivary gland tumours)
Show all 17Show fewer
- Pregnancy and lactation
- Obesity
- Use of analgesics within the last 24 hours
- Oral complaints such as oral dryness
- Mucosal lesions in the oral cavity
- Fewer than 22 natural teeth
- Extensive prosthodontic rehabilitations
- Poor oral hygiene
- Hyposalivation
- Oral diseases (periodontal diseases and mucosal pain or ulcerations)
- Extensive dental abrasion
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Karolinska Institutet, Department of Dental Medicine
Stockholm, Huddinge, 14152
About this study
A large proportion of the adult population worldwide currently lives with chronic muscle pain, with more than half of those affected experiencing pain localized to the face and jaw. This means that approximately 10-15% of the adult population is affected. Living with chronic muscle pain impacts many aspects of life, significantly affecting both the individual's quality of life and well-being as well as that of their close relations.
As with other chronic pain conditions, researchers agree that multiple factors contribute to the development and aggravation of the condition. The aim of this project is to identify proteins in saliva that are involved in the disease process of chronic muscle pain, in order to better understand the underlying mechanisms, improve prognosis assessment, and ultimately develop more effective treatments.
Read more
The project includes patients with localized chronic jaw muscle pain, those with generalized chronic pain (fibromyalgia), and pain-free individuals in a matched control group. Validated questionnaires are used to assess pain, including measures of physical and emotional function, followed by a clinical examination. Chewing-stimulated saliva is selected for sampling based on previous studies from the research group, and blood samples are collected from all participants. Proteins involved in metabolism, stress, and immunity will be analyzed, building on prior research conducted by the group. Patients will undergo conventional orofacial pain treatment and will later be followed up with new samples to study changes in protein expression following successful treatment.
Chronic muscle pain is one of the leading causes of work incapacity and long-term sick leave. This project combines clinical examinations with advanced biomedical analysis methods to investigate the role of specific proteins in disease development. The goal is to identify proteins involved in pain mechanisms to improve diagnostics and enable personalized treatments. In the short term, this could lead to faster and more accurate diagnoses and the development of new treatment strategies, which would reduce pain intensity and work incapacity, ultimately benefiting both individuals and society.
- Conditions
- TMD/Orofacial Pain, Fibromyalgia (FM)
- Medical subject headings
- Fibromyalgia
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 |
|---|---|---|
| Muscle pain | Patients diagnosed with myogenious TMD and patients diagnosed with Fibromyalgia according to ACR 1990/2016 | |
| Control | Matched healthy controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in salivary protein expression levels
Change in salivary protein expression levels (e.g., inflammation-, stress-, or metabolism-related biomarkers) before and after conventional orofacial pain treatment,
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2025
- Study start1 Sep 2023
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TMD/Orofacial PainStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- 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
- Cross-sectional
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Eastmaninstitutet
- Responsible party
- Principal investigator, Hajer Jasim, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06994156
- Sponsor's protocol ID
- DNR 2023-03570-01
- Status last verified
- May 2025
- First submitted
- 20 May 2025
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic and Prognostic Salivary Biomarkers in Chronic Muscle Pain
- ClinicalTrials.gov ID
- NCT06994156
- Acronym / sponsor ID
- DNR 2023-03570-01
- Conditions
- TMD/Orofacial Pain, Fibromyalgia (FM)
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Eastmaninstitutet
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Jan 2029 (estimated)
- First posted
- 29 May 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.
A large proportion of the adult population worldwide currently lives with chronic muscle pain, with more than half of those affected experiencing pain localized to the face and jaw. This means that approximately 10-15% of the adult population is affected. Living with chronic muscle pain impacts many aspects of life, significantly affecting both the individual's quality of life and well-being as well as that of their close relations.
As with other chronic pain conditions, researchers agree that multiple factors contribute to the development and aggravation of the condition. The aim of this project is to identify proteins in saliva that are involved in the disease process of chronic muscle pain, in order to better understand the underlying mechanisms, improve prognosis assessment, and ultimately develop more effective treatments.
The project includes patients with localized chronic jaw muscle pain, those with generalized chronic pain (fibromyalgia), and pain-free individuals in a matched control group. Validated questionnaires are used to assess pain, including measures of physical and emotional function, followed by a clinical examination. Chewing-stimulated saliva is selected for sampling based on previous studies from the research group, and blood samples are collected from all participants. Proteins involved in metabolism, stress, and immunity will be analyzed, building on prior research conducted by the group. Patients will undergo conventional orofacial pain treatment and will later be followed up with new samples to study changes in protein expression following successful treatment.
Chronic muscle pain is one of the leading causes of work incapacity and long-term sick leave. This project combines clinical examinations with advanced biomedical analysis methods to investigate the role of specific proteins in disease development. The goal is to identify proteins involved in pain mechanisms to improve diagnostics and enable personalized treatments. In the short term, this could lead to faster and more accurate diagnoses and the development of new treatment strategies, which would reduce pain intensity and work incapacity, ultimately benefiting both individuals and society.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Muscle pain | – | –Patients diagnosed with myogenious TMD and patients diagnosed with Fibromyalgia according to ACR 1990/2016 |
| Control | – | –Matched healthy controls |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be recruited through advertisement and from patients referred to the specialist clinic for orofacial pain and jaw function at the University Dental Clinic at Karolinska Institute (Huddinge, Sweden) and at Eastman Institutet, Folktandvården Stockholm.
Key inclusion criteria (3 listed)
- Diagnosis of myalgia or myofascial pain with referral according to the DC/TMD Axis I
- Diagnosis of fibromyalgia according to ACR 1990 or ACR 2016 criteria
- Minimum pain intensity of 30 on a 100 mm visual analogue scale (VAS)
Key exclusion criteria (17 listed)
- Diagnosed systemic muscular or joint diseases (except for fibromyalgia)
- Whiplash-associated disorder
- Migraine
- Neurological disorders
- Neuropsychiatric disorders
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
Change in salivary protein expression levels
Time frame: 7 months
Change in salivary protein expression levels (e.g., inflammation-, stress-, or metabolism-related biomarkers) before and after conventional orofacial pain treatment,
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2025.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 TMD/Orofacial Pain and Fibromyalgia (FM), run by Karolinska Institutet at 1 site in Sweden.
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 3 inclusion and 17 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: under way, not looking for participants, as of the sponsor's last update on 4 Jun 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 Sweden. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in salivary protein expression levels (time frame: 7 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Jun 2025.