Temporomandibular DisordersNCT06488937
Biomarkers Associated With Temporomandibular Disorders in Patients With Rheumatoid Arthritis
An observational study of Temporomandibular Disorders and Rheumatoid Arthritis, run by Josip Juraj Strossmayer University of Osijek at 1 site in Croatia.
Trial summary
The goal of this observational study is to determinate temeporomandibular disorders (TMDs) and levels of biomarkers in 30 rheumatoid arthritis patients and 30 healthy controls. Aims are: to determine TMDs symptoms in both groups using a validated Reasearch Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD)… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Temporomandibular Disorders, Rheumatoid Arthritis
- How many people
- 92 participants
- Where
- 1 siteCroatia
- Study dates
- 1 Nov 2019to Feb 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with RA were recruited during their routine monitoring by rheumatologists. The control group were recruited from among regular patients visiting hospital for annual systematic examination.
Who may be able to join
- Signed informed consent, demonstrating that the patient understands the procedures required for the study and the purpose of the study
- Patients diagnosed with RA according to 2010 ACR-EULAR RA criteria.
Who cannot join
- Refusal to sign informed consent form
- Diagnosed chronic systemic disease
- Any infection including TB, HIV, Hepatitis B or C
- Malignancy
- Pregnancy
- Smokers
Trial locations and contacts
1 site in 1 country.
Croatia1 site
Thalassoterapia Opatija, Specijalna bolnica za medicinsku rehabilitaciju bolesti srca, pluća i reumatizma
Opatija, Rijeka, 51101
About this study
Official title: Determinants of Orofacial Pain and Temporomandibular Disorders in People With Rheumatoid Arthritis
The goal of this observational study is to determinate temeporomandibular disorders (TMDs) and levels of biomarkers in 30 rheumatoid arthritis patients and 30 healthy controls.
Aims are:
- to determine TMDs symptoms in both groups using a validated Reasearch Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD) protocol
- to determine levels of interleukin-4 (IL-4), interleukin-18 (IL-18) and interferon-gamma (IFN-γ) in saliva and serum in RA patients and control group
- to determine levels of biomarkers (Ca, Mg, P, AST,ALT,ALP,GGT,urate) in serum of RA patients and control group
- investigate the correlation between cytokines level in saliva and serum
- to determine the effect of TMDs on cytokine and biomarker levels Participants will be clinicaly examined by DMD in accordance with the RDC/TMD guidelines to receive both Axis I and Axis II diagnoses. After examination participants would be asked for saliva and blood sample.
Read the detailed description
Rheumatoid arthritis (RA) is chronic inflammatory autoimmune disease characterized by symmetrical peripheral polyarthritis with consequent joint destruction. Predominantly affecting wrist and foot joints, RA can also affect temporomandibular joint (TMJ) causing temporomandibular disorders (TMDs). 4-80% of RA patients suffer from TMDs.
It remains unclear why some RA patients do not have TMDs and don't suffer from orofacial pain, depression and somatization. The present study was therefore designed to explore the level of cytokines and biochemical parameters from saliva and serum in RA patients and control participants to examine their correlation with TMDs. Study results could provide valuable insights for the understanding of the orofacial pain and depression onset in RA patients Participants would be examined by a non-blinded examiner with knowledge to which group the patient was in. After intraoral examination Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD) will be used as an international diagnostic protocol for TMDs. Assessment included clinical examination of TMJs and masticatory muscles with measurement of mandibular dynamics. The participants will be requested to spit 2 mL of unstimulated saliva into a sterile tube with their head slightly bended forward. Saliva samples were stored at -20℃ until analysis. Blood samples will be collected in Vacutaners. Serum calcium (Ca), magnesium (Mg), phosphate (P), uric acid, alanine aminotransferase (ALT), aspartate aminotransferase (AST) and alkaline phosphatase (ALP) and gamma-glutamyltransferase (GGT) were measured up to 6 hours after collection. Serum aliquots were stored at -20℃ until cytokine analysis. An Invitrogen assays were used to analyze salivary and serum concentration of IL-4,IL-18 and IFN-γ.
- Conditions
- Temporomandibular Disorders, Rheumatoid Arthritis
- Keywords
- RA, rheumatoid arthritis, TMDs, temporomandibular disorders
- Medical subject headings
- Temporomandibular Joint Disorders, Arthritis, Rheumatoid
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 |
|---|---|---|
| RA patients | Patients that are diagnosed rheumatoid arthritis by their rheumatologist according to the 2010 European League Against Rheumatism/American College of Rheumatology classification criteria. | |
| Contorol group | The control group will be patients recruited from among regular patients visiting hospital for annual systematic examination in the same hospital. |
What is being measured
The primary outcome is the main question the study is designed to answer.
levels of cytokines IL-4, IL-18, IFN-γ in serum
Invitrogen assays will be used for multicomplex quantitative analysis of inflammatory mediators. The entire protocol will be carried out according to the instructions of the manufacturer of Thermofischer Scientific
Measured: baseline
levels of cytokines IL-4, IL-18, IFN-γ in saliva
Invitrogen assays will be used for multicomplex quantitative analysis of inflammatory mediators. The entire protocol will be carried out according to the instructions of the manufacturer of Thermofischer Scientific
Measured: baseline
levels of calcium (Ca), magnesium (Mg), phosphate (P), uric acid, alanine aminotransferase (ALT), aspartate aminotransferase (AST) and alkaline phosphatase (ALP) and gamma- glutamyltransferase (GGT) in serum
measured up to 6 hours after collection on Roche Cobas c501 biochemistry analyzer
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2024
- Study start1 Nov 2019
- Primary completion30 May 2022
- Study completionFeb 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 DisordersStudies 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
- 92 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Josip Juraj Strossmayer University of Osijek
- Sponsor type
- University, hospital or other
- Collaborators
- University of Rijeka
- Responsible party
- Principal investigator, Matea Dozet, Josip Juraj Strossmayer University of Osijek
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06488937
- Sponsor's protocol ID
- 01-000-00-678-4./2019.
- Other IDs
- IP2-FDMZ-2021
- Status last verified
- Jun 2024
- First submitted
- 28 Jun 2024
- Last updated
- 5 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mesic VF, Laskarin AM, Kehler T, Spalj S, Dozet M, Pavicic DK. Characteristics of Temporomandibular Disorders and Orofacial Pain in Individuals with Rheumatoid Arthritis. Int J Prosthodont. 2023 Nov 1;36(5):630-636. doi: 10.11607/ijp.8145.
PubMed 36484668
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determinants of Orofacial Pain and Temporomandibular Disorders in People With Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT06488937
- Acronym / sponsor ID
- 01-000-00-678-4./2019.
- Conditions
- Temporomandibular Disorders, Rheumatoid Arthritis
- Keywords
- RA, rheumatoid arthritis, TMDs, temporomandibular disorders
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Josip Juraj Strossmayer University of OsijekUniversity, hospital or other
- Collaborators
- University of Rijeka
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 30 May 2022 (actual)
- Study completion
- Feb 2025 (estimated)
- First posted
- 5 Jul 2024 (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.
The goal of this observational study is to determinate temeporomandibular disorders (TMDs) and levels of biomarkers in 30 rheumatoid arthritis patients and 30 healthy controls.
Aims are:
- to determine TMDs symptoms in both groups using a validated Reasearch Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD) protocol
- to determine levels of interleukin-4 (IL-4), interleukin-18 (IL-18) and interferon-gamma (IFN-γ) in saliva and serum in RA patients and control group
- to determine levels of biomarkers (Ca, Mg, P, AST,ALT,ALP,GGT,urate) in serum of RA patients and control group
- investigate the correlation between cytokines level in saliva and serum
- to determine the effect of TMDs on cytokine and biomarker levels Participants will be clinicaly examined by DMD in accordance with the RDC/TMD guidelines to receive both Axis I and Axis II diagnoses. After examination participants would be asked for saliva and blood sample.
Detailed description
Rheumatoid arthritis (RA) is chronic inflammatory autoimmune disease characterized by symmetrical peripheral polyarthritis with consequent joint destruction. Predominantly affecting wrist and foot joints, RA can also affect temporomandibular joint (TMJ) causing temporomandibular disorders (TMDs). 4-80% of RA patients suffer from TMDs.
It remains unclear why some RA patients do not have TMDs and don't suffer from orofacial pain, depression and somatization. The present study was therefore designed to explore the level of cytokines and biochemical parameters from saliva and serum in RA patients and control participants to examine their correlation with TMDs. Study results could provide valuable insights for the understanding of the orofacial pain and depression onset in RA patients Participants would be examined by a non-blinded examiner with knowledge to which group the patient was in. After intraoral examination Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD) will be used as an international diagnostic protocol for TMDs. Assessment included clinical examination of TMJs and masticatory muscles with measurement of mandibular dynamics. The participants will be requested to spit 2 mL of unstimulated saliva into a sterile tube with their head slightly bended forward. Saliva samples were stored at -20℃ until analysis. Blood samples will be collected in Vacutaners. Serum calcium (Ca), magnesium (Mg), phosphate (P), uric acid, alanine aminotransferase (ALT), aspartate aminotransferase (AST) and alkaline phosphatase (ALP) and gamma-glutamyltransferase (GGT) were measured up to 6 hours after collection. Serum aliquots were stored at -20℃ until cytokine analysis. An Invitrogen assays were used to analyze salivary and serum concentration of IL-4,IL-18 and IFN-γ.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RA patients | – | –Patients that are diagnosed rheumatoid arthritis by their rheumatologist according to the 2010 European League Against Rheumatism/American College of Rheumatology classification criteria. |
| Contorol group | – | –The control group will be patients recruited from among regular patients visiting hospital for annual systematic examination in the same hospital. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with RA were recruited during their routine monitoring by rheumatologists. The control group were recruited from among regular patients visiting hospital for annual systematic examination.
Key inclusion criteria (2 listed)
- Signed informed consent, demonstrating that the patient understands the procedures required for the study and the purpose of the study
- Patients diagnosed with RA according to 2010 ACR-EULAR RA criteria.
Key exclusion criteria (6 listed)
- Refusal to sign informed consent form
- Diagnosed chronic systemic disease
- Any infection including TB, HIV, Hepatitis B or C
- Malignancy
- Pregnancy
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
levels of cytokines IL-4, IL-18, IFN-γ in serum
Time frame: baseline
Invitrogen assays will be used for multicomplex quantitative analysis of inflammatory mediators. The entire protocol will be carried out according to the instructions of the manufacturer of Thermofischer Scientific
levels of cytokines IL-4, IL-18, IFN-γ in saliva
Time frame: baseline
Invitrogen assays will be used for multicomplex quantitative analysis of inflammatory mediators. The entire protocol will be carried out according to the instructions of the manufacturer of Thermofischer Scientific
levels of calcium (Ca), magnesium (Mg), phosphate (P), uric acid, alanine aminotransferase (ALT), aspartate aminotransferase (AST) and alkaline phosphatase (ALP) and gamma- glutamyltransferase (GGT) in serum
Time frame: baseline
measured up to 6 hours after collection on Roche Cobas c501 biochemistry analyzer
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2024.
- Results publication: PubMed 36484668Mesic VF, Laskarin AM, Kehler T, Spalj S, Dozet M, Pavicic DK. Characteristics of Temporomandibular Disorders and Orofacial Pain in Individuals with Rheumatoid Arthritis. Int J Prosthodont. 2023 Nov 1;36(5):630-636. doi: 10.11607/ijp.8145.
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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 Temporomandibular Disorders and Rheumatoid Arthritis, run by Josip Juraj Strossmayer University of Osijek at 1 site in Croatia.
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 2 inclusion and 6 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 5 Jul 2024. 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 Croatia. 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?
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?
levels of cytokines IL-4, IL-18, IFN-γ in serum (time frame: baseline). The study lists 3 primary outcomes in all. 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 NCT06488937, 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 5 Jul 2024.