To contrast jaw exercises and corticosteroid injection via arthrocentesis in children with JIA and MRI confirmed TMJ arthritis despite 1 year regular treatment by the rheumatologist, in a randomized clinical trial, both in combination with continued…
ID
Source
Brief title
Condition
- Autoimmune disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Bite force, mouth opening and MRI outcome over time.
Secondary outcome
Disease activity (JADAS-27) and changes in the TMJ screening protocol score.
Background summary
Juvenile idiopathic arthritis (JIA) is the most common rheumatic disease in
children. According to the ILAR classification, JIA is diagnosed when the
complaints have been present over six weeks, with an onset before the age of
sixteen. Early detection and management of temporomandibular joint (TMJ)
involvement of JIA prevents the sequels of the disease in the masticatory
system such as pain, reduced mouth opening, dysfunction of joints and muscles,
and growth disturbances leading to facial and mandibular deformities.
Regular treatment by the rheumatologist consists of counseling and medication
and seems to reduce the prevalence of mandibular dysfunction and growth
disturbances. In children with TMJ arthritis despite the regular treatment by
the rheumatologist, additional treatment of the masticatory system such as an
intra-articular steroid TMJ injection via arthrocentesis may further improve
oral function. Intra-articular injection is the standard of care in case of
TMJ-arthritis despite regular care. The effects of jaw exercises have not been
studied yet. This intervention may be an alternative for steroid injection to
improve oral function in terms of bite force and other clinical parameters such
as the mouth opening.
Study objective
To contrast jaw exercises and corticosteroid injection via arthrocentesis in
children with JIA and MRI confirmed TMJ arthritis despite 1 year regular
treatment by the rheumatologist, in a randomized clinical trial, both in
combination with continued regular care by the rheumatologist.
The main and secondary study parameters will be evaluated after 12 weeks (short
term efficacy) and 12 months (long term efficacy).
Study design
Open-label parallel randomised trial
Intervention
the interventions for MRI confirmed TMJ arthritis despite one year regular
care in patients with JIA are:
* Regular treatment via the pediatric rheumatologist, consisting of medication
and medical counselling supplemented by arthrocentesis and steroid injection.
* Regular treatment via the pediatric rheumatologist, consisting of medication
and medical counselling supplemented by mandibular exercises and chewing gum
training.
Study burden and risks
The results of this study are expected to contribute to a better understanding
of management of TMJ arthritis in children with JIA and TMJ arthritis not
responding to regular treatment. The burden of participation in our study
consists of I) taking the decision to participate in our study and * on medical
indication - being randomized to one of the two interventions, II) assessment
by the parent of mouth opening and mailing the information to the research
assistant III) measurement of the bite force, IV) clinical TMJ examination and
V) filling out a questionnaire on mandibular function.
The risks of TMJ injections, being the standard care, are to be neglected
(consensus musculoskeletal conditions of the masticatory system). The
non-invasive treatment modality (jaw exercise) is not expected to have
additional risk. It is a more child friendly intervention than a TMJ injection.
Heidelberglaan 100
Utrecht 3584CX
NL
Heidelberglaan 100
Utrecht 3584CX
NL
Listed location countries
Age
Inclusion criteria
o Protocol score of * 2 points on the TMJ screening protocol, items pain and/or reduced maximum mouth opening need to be present
o Age * 6 years; < 16 years of age at JIA diagnosis
o TMJ arthritis despite 1 year regular treatment
o No previous treatment in one of the two arms for TMJ involvement/treatment
o Given oral and written informed consent
Exclusion criteria
o Received previous additional TMJ treatment
o Undergoing orthodontic treatment or planning to start treatment in the next year
o History of mandibular trauma
o Contra-indication of undergoing an MRI exam or undergoing any of the treatment modalities
o Additional orofacial conditions not related with JIA (e.g. dental pain)
o Chewing gum habit (using chewing gum one year or longer on a daily basis), within a half year or less prior to treatment
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL62433.041.17 |