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Effect of Functional Treatment on Mandibular Asymmetric Growth

This study has been completed.
Sponsor:
Collaborator:
Aarhus University Hospital
Information provided by:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01113177
First received: March 15, 2010
Last updated: November 8, 2010
Last verified: November 2010
History of Changes
  Purpose

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.


Condition Intervention
Temporomandibular Joint Disorder
 Device: Distraction splint therapy

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Effect of Functional Treatment on Mandibular Asymmetry Caused by Unilateral Temporomandibular Joint Involvement in Children With Juvenile Idiopathic Arthritis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Mandibular growth in children with unilateral TMJ arthritis treated with an acrylic distraction splint [ Time Frame: average treatment with splint is 6.4 years ] [ Designated as safety issue: No ]
    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.


Enrollment: 22
Study Start Date: June 1994
Study Completion Date: October 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
 Device: Distraction splint therapy
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 Name: functional appliance

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.

  Eligibility

Ages Eligible for Study:   5 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Juvenile Idiopathic arthritis patients diagnosed with unilateral temporomandibular joint arthritis and an asymmetric mandibular growth pattern

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01113177

Locations
Denmark
Dep. of Orthodontics, Aarhus University
Aarhus, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Aarhus University Hospital
Investigators
Study Director: Thomas K Pedersen, DDS Ph.D
  More Information

No publications provided

Responsible Party: Thomas Klit Pedersen, Dep. of orthodontics
ClinicalTrials.gov Identifier: NCT01113177     History of Changes
Other Study ID Numbers: AU-2010
Study First Received: March 15, 2010
Last Updated: November 8, 2010
Health Authority: Denmark: The Ministry of the Interior and Health

Keywords provided by University of Aarhus:
Mandibular growth temporomandibular arthritis

Additional relevant MeSH terms:
Joint Diseases
Temporomandibular Joint Disorders
Temporomandibular Joint Dysfunction Syndrome
Arthritis, Juvenile Rheumatoid
Musculoskeletal Diseases
Craniomandibular Disorders
Mandibular Diseases
Jaw Diseases
Muscular Diseases
 Stomatognathic Diseases
Myofascial Pain Syndromes
Arthritis, Rheumatoid
Arthritis
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 22, 2013