Effect of Functional Treatment on Mandibular Asymmetric Growth

Sponsor
University of Aarhus (Other)
Overall Status
Completed
CT.gov ID
NCT01113177
Collaborator
Aarhus University Hospital (Other)
22
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196
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Study Details

Study Description

Brief 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. 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 or Disease Intervention/Treatment Phase
  • Device: Distraction splint 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

Study Type:
Observational
Actual Enrollment :
22 participants
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
Study Start Date :
Jun 1, 1994
Actual Primary Completion Date :
Sep 1, 2010
Actual Study Completion Date :
Oct 1, 2010

Arms and Interventions

Arm 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.

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 Names:
  • functional appliance
  • Outcome Measures

    Primary Outcome Measures

    1. Mandibular growth in children with unilateral TMJ arthritis treated with an acrylic distraction splint [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    5 Years to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 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,

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01113177
    Other Study ID Numbers:
    • AU-2010
    First Posted:
    Apr 29, 2010
    Last Update Posted:
    Nov 9, 2010
    Last Verified:
    Nov 1, 2010

    Study Results

    No Results Posted as of Nov 9, 2010