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OpenTrials
Completed

NCT Number: NCT01113177

Effect of Functional Treatment on Mandibular Asymmetric Growth

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.

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Key information

Age range

5 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Dep. of Orthodontics, Aarhus University

Aarhus, 8000, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Distraction splint therapy

Device

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

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Aarhus University Hospital

Registry information

Official study title

Effect of Functional Treatment on Mandibular Asymmetry Caused by Unilateral Temporomandibular Joint Involvement in Children With Juvenile Idiopathic Arthritis

Important dates

Study start
1994
Primary completion
2010
Study completion
2010
First posted
Apr 29, 2010
Registry last updated
Nov 9, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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