- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01113177
Effect of Functional Treatment on Mandibular Asymmetric Growth
November 8, 2010 updated by: University of Aarhus
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
22
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Aarhus, Denmark, 8000
- Dep. of Orthodontics, Aarhus University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
5 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Juvenile Idiopathic arthritis patients diagnosed with unilateral temporomandibular joint arthritis and an asymmetric mandibular growth pattern
Description
Inclusion Criteria:
- Juvenile Idiopathic arthritis patients diagnosed with unilateral temporomandibular joint arthritis and an asymmetric mandibular growth pattern
Exclusion Criteria:
- Juvenile Idiopathic arthritis patients diagnosed with bilateral temporomandibular joint arthritis
- Juvenile Idiopathic arthritis patients with no mandibular growth potential left.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
|
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).
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
average treatment with splint is 6.4 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Thomas K Pedersen, DDS Ph.D
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 1994
Primary Completion (Actual)
September 1, 2010
Study Completion (Actual)
October 1, 2010
Study Registration Dates
First Submitted
March 15, 2010
First Submitted That Met QC Criteria
April 27, 2010
First Posted (Estimate)
April 29, 2010
Study Record Updates
Last Update Posted (Estimate)
November 9, 2010
Last Update Submitted That Met QC Criteria
November 8, 2010
Last Verified
November 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AU-2010
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Temporomandibular Joint Disorder
-
CES UniversityCompletedTemporomandibular Disorder | Children, Only | Pain Disorder | Joint Disorder, Temporomandibular
-
Hacettepe UniversityThe Scientific and Technological Research Council of TurkeyRecruitingTemporomandibular Joint Disorders | Temporomandibular Joint Dysfunction Syndrome | Temporomandibular Disorder | Temporomandibular Joint Pain | Manual Therapy | Temporomandibular Joint Disc DisplacementTurkey
-
TC Erciyes UniversityRecruitingTemporomandibular Joint Disorders | Temporomandibular Disorder | Temporomandibular Joint Pain | Temporomandibular Joint Osteoarthritis | Temporomandibular Joint EffusionTurkey
-
University of AlcalaCompletedTemporomandibular DisorderSpain
-
University of Nove de JulhoUnknownTemporomandibular DisorderBrazil
-
Hacettepe UniversityKarabuk UniversityRecruitingTemporomandibular Joint Disorders | Temporomandibular Joint Dysfunction Syndrome | Temporomandibular DisorderTurkey
-
Logan College of ChiropracticUnknownTemporomandibular Joint Dysfunction Syndrome | Temporomandibular Joint Disorder | Temporomandibular JointUnited States
-
Wroclaw Medical UniversityEnrolling by invitationTemporomandibular Joint Disorders | Temporomandibular Disorder | Temporomandibular Joint Osteoarthritis | Temporomandibular ArthritisPoland
-
Beirut Arab UniversityRecruitingTemporomandibular DisorderLebanon
-
Riphah International UniversityRecruitingTemporomandibular DisorderPakistan
Clinical Trials on Distraction splint therapy
-
Paolo PillastriniCompletedTemporomandibular DisorderItaly
-
Mansoura UniversityCompletedTMJ Disc DisorderEgypt
-
Chang Gung Memorial HospitalCompleted
-
NYU Langone HealthRecruitingDistal Radius FractureUnited States
-
Azienda Usl di BolognaRecruitingNarcolepsy Type 1 | Sleep ParalysisItaly
-
Wayne State UniversityCompletedNeurological DisordersUnited States
-
Hacettepe UniversityRecruitingTrigger Finger | Stenosing TenosynovitisTurkey
-
Duke UniversityRecruiting
-
Superior UniversityRecruiting
-
Fonseca, JulioUnknownTMJ Disc Disorder | TMJ Pain | TMJ Sounds on Opening/Closing the Jaw | TMJ - Injury of Meniscus of Temporomandibular JointPortugal