Juvenile Idiopathic ArthritisNCT02218892
Prediction of Temporomandibular Involvement in Juvenile Idiopathic Arthritis
An observational study of Juvenile Idiopathic Arthritis and Temporomandibular Arthritis, run by Malin Collin at 1 site in Sweden.
Trial summary
Purpose and aims The general aim of this project is to improve the diagnostic methods for disease activity and identify predictive factors (clinical and radiographic factors, pro- and anti-inflammatory mediators in saliva and plasma) for temporomandibular joint (TMJ) involvement in juvenile idiopathic arthritis (JIA). Read more about this study
- Who is it for?
- Ages 7 to 14 years
- Conditions the study is for
- Juvenile Idiopathic Arthritis, Temporomandibular Arthritis
- How many people
- 62 participants
- Where
- 1 siteSweden
- Study dates
- Feb 2011to Dec 2023
- 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 7 to 14 years
- All sexes
- No healthy volunteers
- Child
Study population: One-hundred consecutive patients with active JIA, as diagnosed by the Department of Pediatric Rheumatology, Astrid Lindgrens Barnsjukhus, Karolinska University Hospital will be included.
Who may be able to join
- age between 7 and 14 years
- a diagnosis of JIA according to the International League of Associations for rheumatology (ILAR) The parents of the patients and/or the patients will give their verbal and written informed consent to participate in the study according to the permission from the regional ethical committee 2011/2:1.
Who cannot join
- current malignancies
- TMJ surgery or trauma within two years
- recent intra-articular glucocorticoid injection in TMJ (within 1 month)
- other conditions or diseases than JIA that may cause orofacial pain.
Trial locations and contacts
1 site in 1 country.
About this study
Purpose and aims The general aim of this project is to improve the diagnostic methods for disease activity and identify predictive factors (clinical and radiographic factors, pro- and anti-inflammatory mediators in saliva and plasma) for temporomandibular joint (TMJ) involvement in juvenile idiopathic arthritis (JIA).
The hypothesis is that self-reported pain and impaired jaw function together with clinical findings correlates well with radiological signs of jaw involvement.
Read more
Null hypothesis: Self-reported pain, impaired jaw function and clinical findings do not correlate with radiological signs of jaw involvement.
Study 1 The aim of this study is to investigate which findings from the patient history and from clinical examination that is of significance for diagnostics of TMJ involvement in patients with JIA both in a short- and long-term perspective. The patients will be followed-up during two years. They will undergo a clinical examination according to Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD; Dworkin and LeResche 1992) once a year and a telephone follow-up sixth months after the clinical examination. Further, the clinical findings from the orofacial regions will be compared to their general disease activity.
Study 2 The aim of the second study is to correlate radiological findings and clinical findings in order to investigate any early radiological signs of disease activity and progression but also to compare the radiographic examination using conventional panoramic technique with computer tomography (CT).
Read the detailed description
One-hundred consecutive patients with active JIA, as diagnosed by the Department of Pediatric Rheumatology, Astrid Lindgrens Barnsjukhus, Karolinska University Hospital will be included.
Inclusion criteria are:
- age between 7 and 14 years
- a diagnosis of JIA according to the International League of Associations for rheumatology
Exclusion criteria are:
- current malignancies
- TMJ surgery or trauma within two years
- recent intra-articular glucocorticoid injection in TMJ (within 1 month)
- other conditions or diseases than JIA that may cause orofacial pain. The parents of the patients and/or the patients will give their verbal and written informed consent to participate in the study according to the permission from the regional ethical committee 2011/2:1.
Clinical examination and follow-ups The patients will be examined clinically three times with an interval of 12 months. The clinical examination will be performed according to the RDC-TMD by calibrated investigators. Panoramic x-ray and CT scans will be performed at the inclusion examination as well as at the end of the study after 24 months. Pharmacological treatment will be recorded at every clinical examination and at telephone interviews. The patients will also be examined by a pediatric rheumatologist regarding general disease activity according to the Juvenile Arthritis Disease Activity Score 27 (JADAS-27), the Short Form (36) Health Survey (SF-36), thrombocyte particle count, C-reactive protein and blood titer of rheumatoid factor and anti-cyclic citrullinated peptides. Information from the examination by the pediatric rheumatologist will be drawn from the Swedish national register for children with JIA.
Telephone interview Six months after the first and second visit, a structured telephone interview with the patients and/or their parents will be performed according to a questionnaire. The objective is to estimate the degree of joint pain and functional limitations in jaw function.
Radiological examination Conventional panoramic x-rays and bilateral TMJ images will be obtained with the digital volume tomography (DVT, New Tom Model QR-DVT 9000, New Tom AG, Marburg, Germany). The CT sections will be evaluated by a specialist in oral radiology for presence of radiographic signs of cortical and subcortical erosions, flattening, sclerosis and ramus height.
- Medical subject headings
- Arthritis, Juvenile
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 |
|---|---|---|
| Juvenil Idiopathic Arthritis | The group consists of children age 7-14 with an diagnosis of active Juvenile Idiopathic Arthritis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical findings in children with JIA
To find similarities in patients with JIA according to RDC-TMD (a clinical protocol validated for children)
Measured: 2 years
Radiographic findings in children with JIA
Repeated radiographic examination
Measured: Two years
Patient history
Repeated interview on function and pain in the jaw area
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2014 (estimated)
- Study startFeb 2011
- Primary completionAug 2017
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Juvenile Idiopathic ArthritisStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Malin Collin
- Sponsor type
- Other government
- Collaborators
- Karolinska Institutet
- Responsible party
- Sponsor-investigator, Malin Collin, Folktandvården Stockholms län AB
- Investigators
- Britt Hedenberg Magnusson, PhD DDS, Study director, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02218892
- Sponsor's protocol ID
- 2010/2089-31/2
- Status last verified
- Mar 2023
- First submitted
- 30 Jun 2014
- Last updated
- 6 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Temporomandibular Involvement in Juvenile Idiopathic Arthritis
- ClinicalTrials.gov ID
- NCT02218892
- Acronym / sponsor ID
- 2010/2089-31/2
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Malin CollinOther government
- Collaborators
- Karolinska Institutet
- Study start
- Feb 2011
- Primary completion
- Aug 2017 (actual)
- Study completion
- Dec 2023 (estimated)
- First posted
- 18 Aug 2014 (estimated)
- 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.
Purpose and aims The general aim of this project is to improve the diagnostic methods for disease activity and identify predictive factors (clinical and radiographic factors, pro- and anti-inflammatory mediators in saliva and plasma) for temporomandibular joint (TMJ) involvement in juvenile idiopathic arthritis (JIA).
The hypothesis is that self-reported pain and impaired jaw function together with clinical findings correlates well with radiological signs of jaw involvement.
Null hypothesis: Self-reported pain, impaired jaw function and clinical findings do not correlate with radiological signs of jaw involvement.
Study 1 The aim of this study is to investigate which findings from the patient history and from clinical examination that is of significance for diagnostics of TMJ involvement in patients with JIA both in a short- and long-term perspective. The patients will be followed-up during two years. They will undergo a clinical examination according to Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD; Dworkin and LeResche 1992) once a year and a telephone follow-up sixth months after the clinical examination. Further, the clinical findings from the orofacial regions will be compared to their general disease activity.
Study 2 The aim of the second study is to correlate radiological findings and clinical findings in order to investigate any early radiological signs of disease activity and progression but also to compare the radiographic examination using conventional panoramic technique with computer tomography (CT).
Detailed description
One-hundred consecutive patients with active JIA, as diagnosed by the Department of Pediatric Rheumatology, Astrid Lindgrens Barnsjukhus, Karolinska University Hospital will be included.
Inclusion criteria are:
- age between 7 and 14 years
- a diagnosis of JIA according to the International League of Associations for rheumatology
Exclusion criteria are:
- current malignancies
- TMJ surgery or trauma within two years
- recent intra-articular glucocorticoid injection in TMJ (within 1 month)
- other conditions or diseases than JIA that may cause orofacial pain. The parents of the patients and/or the patients will give their verbal and written informed consent to participate in the study according to the permission from the regional ethical committee 2011/2:1.
Clinical examination and follow-ups The patients will be examined clinically three times with an interval of 12 months. The clinical examination will be performed according to the RDC-TMD by calibrated investigators. Panoramic x-ray and CT scans will be performed at the inclusion examination as well as at the end of the study after 24 months. Pharmacological treatment will be recorded at every clinical examination and at telephone interviews. The patients will also be examined by a pediatric rheumatologist regarding general disease activity according to the Juvenile Arthritis Disease Activity Score 27 (JADAS-27), the Short Form (36) Health Survey (SF-36), thrombocyte particle count, C-reactive protein and blood titer of rheumatoid factor and anti-cyclic citrullinated peptides. Information from the examination by the pediatric rheumatologist will be drawn from the Swedish national register for children with JIA.
Telephone interview Six months after the first and second visit, a structured telephone interview with the patients and/or their parents will be performed according to a questionnaire. The objective is to estimate the degree of joint pain and functional limitations in jaw function.
Radiological examination Conventional panoramic x-rays and bilateral TMJ images will be obtained with the digital volume tomography (DVT, New Tom Model QR-DVT 9000, New Tom AG, Marburg, Germany). The CT sections will be evaluated by a specialist in oral radiology for presence of radiographic signs of cortical and subcortical erosions, flattening, sclerosis and ramus height.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Juvenil Idiopathic Arthritis | – | –The group consists of children age 7-14 with an diagnosis of active Juvenile Idiopathic Arthritis. |
Who may qualify
- Ages
- 7 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- One-hundred consecutive patients with active JIA, as diagnosed by the Department of Pediatric Rheumatology, Astrid Lindgrens Barnsjukhus, Karolinska University Hospital will be included.
Key inclusion criteria (2 listed)
- age between 7 and 14 years
- a diagnosis of JIA according to the International League of Associations for rheumatology (ILAR) The parents of the patients and/or the patients will give their verbal and written informed consent to participate in the study according to the permission from the regional ethical committee 2011/2:1.
Key exclusion criteria (4 listed)
- current malignancies
- TMJ surgery or trauma within two years
- recent intra-articular glucocorticoid injection in TMJ (within 1 month)
- other conditions or diseases than JIA that may cause orofacial pain.
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
Clinical findings in children with JIA
Time frame: 2 years
To find similarities in patients with JIA according to RDC-TMD (a clinical protocol validated for children)
Radiographic findings in children with JIA
Time frame: Two years
Repeated radiographic examination
Patient history
Time frame: Two years
Repeated interview on function and pain in the jaw area
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2023.
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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.
Britt Hedenberg Magnusson, PhD DDS study director
Karolinska Institutet
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 Juvenile Idiopathic Arthritis and Temporomandibular Arthritis, run by Malin Collin 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 2 inclusion and 4 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 6 Mar 2023. 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?
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?
Clinical findings in children with JIA (time frame: 2 years). 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?
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 6 Mar 2023.