Effect of Functional Treatment on Mandibular Asymmetric Growth

NCT01113177 | Completed

• 1 other identifier: AU-2010
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Temporomandibular Joint Disorder

Keywords

Mandibular growth temporomandibular arthritis

Outcome Measures

Primary Outcomes (1)

• Mandibular growth in children with unilateral TMJ arthritis treated with an acrylic distraction splint

  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

Study Arms (1)

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

Interventions

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).

Also known as: functional appliance

Distraction splint therapy

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• Juvenile Idiopathic arthritis patients diagnosed with bilateral temporomandibular joint arthritis
• Juvenile Idiopathic arthritis patients with no mandibular growth potential left.

Sponsors & Collaborators

• University of Aarhus: lead
• Aarhus University Hospital: collaborator

Study Sites (1)

Dep. of Orthodontics, Aarhus University

Aarhus, 8000, Denmark

Location

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases

Study Officials

• Thomas K Pedersen, DDS Ph.D

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 15, 2010
• First Posted: April 29, 2010
• Study Start: June 1, 1994
• Primary Completion: September 1, 2010
• Study Completion: October 1, 2010
• Last Updated: November 9, 2010

Record last verified: 2010-11

Locations

DK (1)