Temporomandibular Joint DisorderNCT01113177
Effect of Functional Treatment on Mandibular Asymmetric Growth
An observational study of Temporomandibular Joint Disorder, run by University of Aarhus at 1 site in Denmark.
Trial summary
Temporomandibular joint (TMJ) arthritis is known to alter the mandibular development in children diagnosed with juvenile idiopathic arthritis. In a number of cases a genuine breakdown of cartilage and bone is seen in the affected joint which leads to asymmetric mandibular growth in the affected side. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Temporomandibular Joint Disorder
- What is being tested?
- Distraction splint therapy
- Type of treatment
- Medical device
- How many people
- 22 participants
- Where
- 1 siteDenmark
- Study dates
- Jun 1994to Oct 2010
- 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 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Juvenile Idiopathic arthritis patients diagnosed with unilateral temporomandibular joint arthritis and an asymmetric mandibular growth pattern
Who may be able to join
- Juvenile Idiopathic arthritis patients diagnosed with unilateral temporomandibular joint arthritis and an asymmetric mandibular growth pattern
Who cannot join
- Juvenile Idiopathic arthritis patients diagnosed with bilateral temporomandibular joint arthritis
- Juvenile Idiopathic arthritis patients with no mandibular growth potential left.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Functional Treatment on Mandibular Asymmetry Caused by Unilateral Temporomandibular Joint Involvement in Children With Juvenile Idiopathic Arthritis
Temporomandibular joint (TMJ) arthritis is known to alter the mandibular development in children diagnosed with juvenile idiopathic arthritis. In a number of cases a genuine breakdown of cartilage and bone is seen in the affected joint which leads to asymmetric mandibular growth in the affected side. In cases of unilateral TMJ involvements severe mandibular asymmetric mandibular growth deviations are seen. We hypothesize that these growth deviations can be minimized and controlled by the use functional orthodontic appliance therapy.
Read the detailed description
This is a retrospective study design with the aim to evaluate the clinical procedures we have used the last 15 years to treat JIA patients with unilateral TMJ arthritis. More specifically, the purpose is to evaluate the mandibular growth in all JIA patients with unilateral TMJ arthritis and an asymmetric mandibular growth pattern treated with non-surgical distraction splint therapy between 1994 and 2010 at the dep. of Orthodontics, Aarhus University, Denmark. The evaluation is based on radiological examinations at the beginning of their non-surgical distraction treatment as well as after the patients have finished their distraction-splint therapy.
- Conditions
- Temporomandibular Joint Disorder
- Being tested
- Distraction splint therapy
- Keywords
- Mandibular growth temporomandibular arthritis
- Medical subject headings
- Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Distraction splint therapyDevice
Also called functional appliance
After the diagnosis of unilateral TMJ arthritis with clinical asymmetric mandibular growth deviations the JIA patients are offered treatment with a distraction splint. The appliance consists of an acrylic splint (distraction splint) covering the occlusal surfaces of the teeth in the upper or lower dental arch. The height of the splint is thereafter gradually increased every 6th to 10th weeks in order to optimize the mandible growth in the affected side and thereby reduce the overall asymmetric mandibular growth pattern(non-surgical distraction of the TMJ and mandibular condyle).
| Study group | Role | What they receive |
|---|---|---|
| Distraction splint therapy | All JIA patients with asymmetric mandibular growth due to unilateral TMJ arthritis are offered non-surgical functional orthodontic splint therapy with a distraction splint. Mandibular growth is thereafter evaluated in the affected side compared with the mandibular growth in the healthy side of the same individual. Receives: Device: Distraction splint therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mandibular growth in children with unilateral TMJ arthritis treated with an acrylic distraction splint
The craniofacial dimensions are measured radiologically prior to the start of the treatment with the distraction splint. Second measurements of the craniofacial dimensions are evaluated after the patients have ended the treatment with the distraction splint. In that way we are able to evaluate the craniofacial growth in the affected side compared to the craniofacial growth in the "healthy" side in JIA patients with unilateral TMJ arthritis. The succces of the distraction splint treatment is decided based the splints ability to normalize the craniofacial growth in the affacted side.
Measured: average treatment with splint is 6.4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2010 (estimated)
- Study startJun 1994
- Primary completionSep 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular Joint DisorderStudies of the same condition, open and under way.
- More trials run by University of AarhusThe 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 only
- Time perspective
- Retrospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital
- Investigators
- Thomas K Pedersen, DDS Ph.D, Study director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01113177
- Sponsor's protocol ID
- AU-2010
- Status last verified
- Nov 2010
- First submitted
- 15 Mar 2010
- Last updated
- 9 Nov 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Functional Treatment on Mandibular Asymmetry Caused by Unilateral Temporomandibular Joint Involvement in Children With Juvenile Idiopathic Arthritis
- ClinicalTrials.gov ID
- NCT01113177
- Acronym / sponsor ID
- AU-2010
- Conditions
- Temporomandibular Joint Disorder
- Keywords
- Mandibular growth temporomandibular arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital
- Study start
- Jun 1994
- Primary completion
- Sep 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 29 Apr 2010 (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.
Temporomandibular joint (TMJ) arthritis is known to alter the mandibular development in children diagnosed with juvenile idiopathic arthritis. In a number of cases a genuine breakdown of cartilage and bone is seen in the affected joint which leads to asymmetric mandibular growth in the affected side. In cases of unilateral TMJ involvements severe mandibular asymmetric mandibular growth deviations are seen. We hypothesize that these growth deviations can be minimized and controlled by the use functional orthodontic appliance therapy.
Detailed description
This is a retrospective study design with the aim to evaluate the clinical procedures we have used the last 15 years to treat JIA patients with unilateral TMJ arthritis. More specifically, the purpose is to evaluate the mandibular growth in all JIA patients with unilateral TMJ arthritis and an asymmetric mandibular growth pattern treated with non-surgical distraction splint therapy between 1994 and 2010 at the dep. of Orthodontics, Aarhus University, Denmark. The evaluation is based on radiological examinations at the beginning of their non-surgical distraction treatment as well as after the patients have finished their distraction-splint therapy.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Distraction splint therapy | – | Device: Distraction splint therapyAll JIA patients with asymmetric mandibular growth due to unilateral TMJ arthritis are offered non-surgical functional orthodontic splint therapy with a distraction splint. Mandibular growth is thereafter evaluated in the affected side compared with the mandibular growth in the healthy side of the same individual. |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Juvenile Idiopathic arthritis patients diagnosed with unilateral temporomandibular joint arthritis and an asymmetric mandibular growth pattern
Key inclusion criteria (1 listed)
- Juvenile Idiopathic arthritis patients diagnosed with unilateral temporomandibular joint arthritis and an asymmetric mandibular growth pattern
Key exclusion criteria (2 listed)
- Juvenile Idiopathic arthritis patients diagnosed with bilateral temporomandibular joint arthritis
- Juvenile Idiopathic arthritis patients with no mandibular growth potential left.
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 |
|---|---|---|
| Distraction splint therapyAlso: functional applianceAfter the diagnosis of unilateral TMJ arthritis with clinical asymmetric mandibular growth deviations the JIA patients are offered treatment with a distraction splint. The appliance consists of an acrylic splint (distraction splint) covering the occlusal surfaces of the teeth in the upper or lower dental arch. The height of the splint is thereafter gradually increased every 6th to 10th weeks in order to optimize the mandible growth in the affected side and thereby reduce the overall asymmetric mandibular growth pattern(non-surgical distraction of the TMJ and mandibular condyle). | Device | Distraction splint therapy |
Primary outcome
Mandibular growth in children with unilateral TMJ arthritis treated with an acrylic distraction splint
Time frame: average treatment with splint is 6.4 years
The craniofacial dimensions are measured radiologically prior to the start of the treatment with the distraction splint. Second measurements of the craniofacial dimensions are evaluated after the patients have ended the treatment with the distraction splint. In that way we are able to evaluate the craniofacial growth in the affected side compared to the craniofacial growth in the "healthy" side in JIA patients with unilateral TMJ arthritis. The succces of the distraction splint treatment is decided based the splints ability to normalize the craniofacial growth in the affacted side.
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 9 Nov 2010.
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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.
Thomas K Pedersen, DDS Ph.D study director
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 Joint Disorder, run by University of Aarhus at 1 site in Denmark.
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 1 inclusion and 2 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 9 Nov 2010. 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 Denmark. 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?
Mandibular growth in children with unilateral TMJ arthritis treated with an acrylic distraction splint (time frame: average treatment with splint is 6.4 years). 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 9 Nov 2010.