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Effect of Functional Treatment on Mandibular Asymmetric Growth

NCT ID: NCT01113177

Last Updated: 2010-11-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

22 participants

Study Classification

OBSERVATIONAL

Study Start Date

1994-06-30

Study Completion Date

2010-10-31

Brief Summary

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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

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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

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Temporomandibular Joint Disorder

Keywords

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Mandibular growth temporomandibular arthritis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

Distraction splint therapy

Intervention Type 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).

Interventions

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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).

Intervention Type DEVICE

Other Intervention Names

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functional appliance

Eligibility Criteria

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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.
Minimum Eligible Age

5 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aarhus University Hospital

OTHER

Sponsor Role collaborator

University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Dep. of orthodontics

Principal Investigators

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Thomas K Pedersen, DDS Ph.D

Role: STUDY_DIRECTOR

Locations

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Dep. of Orthodontics, Aarhus University

Aarhus, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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AU-2010

Identifier Type: -

Identifier Source: org_study_id