Juvenile Idiopathic ArthritisNCT03008681
OHRQoL Evaluation After Functional Therapy in JIA Patients
A study testing Andresen functional removable orthodontic appliance in people with Juvenile Idiopathic Arthritis, run by University of Messina at 1 site in Italy.
Trial summary
The aim of the study was to determine the changes in Oral Health-Related Quality of Life (OHRQoL) in patients with juvenile idiopathic arthritis (JIA) and temporomandibular joint (TMJ) disorders who underwent functional therapy for 24 months to assess the age and sex group in which the functional therapy was most… Read more about this study
- Who is it for?
- Ages 8 to 20 years
- Conditions the study is for
- Juvenile Idiopathic Arthritis
- What is being tested?
- Andresen functional removable orthodontic appliance
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2004to Oct 2016
- Phase
- Interventional
- 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 8 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- The inclusion criteria were:
- JIA with unilateral or bilateral TMJ arthritis treated with a functional appliance;
- Clear signs or symptoms of TMJ arthritis based on clinical and radiological examination.
- No administration of intra-articular TMJ steroid injections throughout the course of the orthopaedic functional treatment.
Who cannot join
- previous orthodontic treatment;
- history of maxillofacial surgery;
- genetic diseases, syndromes, other congenital deformities or any concurrent medical condition.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Oral Health-Related Quality of Life in Patients With Juvenile Idiopathic Arthritis and Temporomandibular Joint Disorders Evaluation After Treatment With a Functional Appliance
The aim of the study was to determine the changes in Oral Health-Related Quality of Life (OHRQoL) in patients with juvenile idiopathic arthritis (JIA) and temporomandibular joint (TMJ) disorders who underwent functional therapy for 24 months to assess the age and sex group in which the functional therapy was most effective.
Read the detailed description
This prospective interventional study included 93 patients with JIA and TMJ disorders at the start of functional orthodontic therapy. Children were prospectively followed in the 24 months of treatment and completed the Oral Health Impact Profile (OHIP-14) before treatment (T0), and at 6 months (T1), 12 months (T2), and 24 months (T3) after the start of therapy.
- Conditions
- Juvenile Idiopathic Arthritis
- Being tested
- Andresen functional removable orthodontic appliance
- Medical subject headings
- Arthritis, Juvenile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Andresen functional removable orthodontic applianceDevice
Also called Andresen Activator
Included patients were treated for 24 months with a Functional removable orthodontic appliance, the Andresen activator. The initial checks were performed after 6 weeks with subsequent checks being carried out every 8th week, with the final follow-up at 24 months. The patient underwent functional treatment using the activator described in the protocol with midlines coincidence.
| Study group | Role | What they receive |
|---|---|---|
| Andresen functional removable orthodontic appliance | Experimental | All the enrolled patients was applied the Andresen Activator (a removable orthodontic appliance) 12-14 hours in a day in total.
Functional appliances helped the movement of the teeth, with the achievement of good facial muscle function. All patients in the cohort were treated with the andresen actovator appliancev for deep bite and class II malocclusion correction.
The appliances were individually manufactured of acrylic resin, with a central screw and a vestibular arch, fabricated through a wax bite registration; the patient was guided to close the mouth in mandibular protrusion with coincidence of the upper and lower midlines. The registration bite was very thin in order to obtain a minimum vertical dimension. The activator was modified every three months increasing its posterior vertical dimension in order to stimulate the mandibular ramus growth thanks to the dislocation of the mandibular condyle. Receives: Device: Andresen functional removable orthodontic appliance |
What is being measured
The primary outcome is the main question the study is designed to answer.
TMJ disorder cessation
TMJ disorder and clinical mandibular symmetry was achieved or if mandibular growth was estimated as ceased.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2017 (estimated)
- Study startJan 2004
- Primary completionSep 2016
- Study completionOct 2016
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 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Messina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gaetano Isola, DDS, PhD, University of Messina
- Investigators
- Giovanni Matarese, DDS, Study director, University of Messina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03008681
- Sponsor's protocol ID
- 2010-918
- Status last verified
- Dec 2016
- First submitted
- 26 Dec 2016
- Last updated
- 2 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Isola G, Perillo L, Migliorati M, Matarese M, Dalessandri D, Grassia V, Alibrandi A, Matarese G. The impact of temporomandibular joint arthritis on functional disability and global health in patients with juvenile idiopathic arthritis. Eur J Orthod. 2019 Mar 29;41(2):117-124. doi: 10.1093/ejo/cjy034.
PubMed 29878100
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Health-Related Quality of Life in Patients With Juvenile Idiopathic Arthritis and Temporomandibular Joint Disorders Evaluation After Treatment With a Functional Appliance
- ClinicalTrials.gov ID
- NCT03008681
- Acronym / sponsor ID
- 2010-918
- Conditions
- Juvenile Idiopathic Arthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- University of MessinaUniversity, hospital or other
- Study start
- Jan 2004
- Primary completion
- Sep 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 2 Jan 2017 (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.
The aim of the study was to determine the changes in Oral Health-Related Quality of Life (OHRQoL) in patients with juvenile idiopathic arthritis (JIA) and temporomandibular joint (TMJ) disorders who underwent functional therapy for 24 months to assess the age and sex group in which the functional therapy was most effective.
Detailed description
This prospective interventional study included 93 patients with JIA and TMJ disorders at the start of functional orthodontic therapy. Children were prospectively followed in the 24 months of treatment and completed the Oral Health Impact Profile (OHIP-14) before treatment (T0), and at 6 months (T1), 12 months (T2), and 24 months (T3) after the start of therapy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Andresen functional removable orthodontic appliance | Experimental | Device: Andresen functional removable orthodontic applianceAll the enrolled patients was applied the Andresen Activator (a removable orthodontic appliance) 12-14 hours in a day in total. Functional appliances helped the movement of the teeth, with the achievement of good facial muscle function. All patients in the cohort were treated with the andresen actovator appliancev for deep bite and class II malocclusion correction. The appliances were individually manufactured of acrylic resin, with a central screw and a vestibular arch, fabricated through a wax bite registration; the patient was guided to close the mouth in mandibular protrusion with coincidence of the upper and lower midlines. The registration bite was very thin in order to obtain a minimum vertical dimension. The activator was modified every three months increasing its posterior vertical dimension in order to stimulate the mandibular ramus growth thanks to the dislocation of the mandibular condyle. |
Who may qualify
- Ages
- 8 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- JIA with unilateral or bilateral TMJ arthritis treated with a functional appliance;
- Clear signs or symptoms of TMJ arthritis based on clinical and radiological examination.
- No administration of intra-articular TMJ steroid injections throughout the course of the orthopaedic functional treatment.
Key exclusion criteria (3 listed)
- previous orthodontic treatment;
- history of maxillofacial surgery;
- genetic diseases, syndromes, other congenital deformities or any concurrent medical condition.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Andresen functional removable orthodontic applianceAlso: Andresen ActivatorIncluded patients were treated for 24 months with a Functional removable orthodontic appliance, the Andresen activator. The initial checks were performed after 6 weeks with subsequent checks being carried out every 8th week, with the final follow-up at 24 months. The patient underwent functional treatment using the activator described in the protocol with midlines coincidence. | Device | Andresen functional removable orthodontic appliance |
Primary outcome
TMJ disorder cessation
Time frame: 24 months
TMJ disorder and clinical mandibular symmetry was achieved or if mandibular growth was estimated as ceased.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2017.
- Derived from this study: PubMed 29878100Isola G, Perillo L, Migliorati M, Matarese M, Dalessandri D, Grassia V, Alibrandi A, Matarese G. The impact of temporomandibular joint arthritis on functional disability and global health in patients with juvenile idiopathic arthritis. Eur J Orthod. 2019 Mar 29;41(2):117-124. doi: 10.1093/ejo/cjy034.
- 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.
Giovanni Matarese, DDS study director
University of Messina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Andresen functional removable orthodontic appliance in people with Juvenile Idiopathic Arthritis, run by University of Messina at 1 site in Italy.
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 4 inclusion and 3 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: finished, as of the sponsor's last update on 2 Jan 2017. 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 Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
TMJ disorder cessation (time frame: 24 months). 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 NCT03008681, 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 2 Jan 2017.