Skip to main content
OpenTrials
Completed

NCT Number: NCT03008681

OHRQoL Evaluation After Functional Therapy in JIA Patients

The aim of the study was to determine the changes in Oral Health-Related Quality of Life (OHRQoL) in patients with juvenile idiopathic arthritis (JIA) and temporomandibular joint (TMJ) disorders who underwent functional therapy for 24 months to assess the age and sex group in which the functional therapy was most effective.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Juvenile Idiopathic Arthritis Arthritis Arthritis, Juvenile Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

8 year–20 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Messina

Messina, Italy, 98125

About this study

This prospective interventional study included 93 patients with JIA and TMJ disorders at the start of functional orthodontic therapy. Children were prospectively followed in the 24 months of treatment and completed the Oral Health Impact Profile (OHIP-14) before treatment (T0), and at 6 months (T1), 12 months (T2), and 24 months (T3) after the start of therapy.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

The inclusion criteria were:

  • JIA with unilateral or bilateral TMJ arthritis treated with a functional appliance;
  • Clear signs or symptoms of TMJ arthritis based on clinical and radiological examination.
  • No administration of intra-articular TMJ steroid injections throughout the course of the orthopaedic functional treatment.

Exclusion criteria

  • previous orthodontic treatment;
  • history of maxillofacial surgery;
  • genetic diseases, syndromes, other congenital deformities or any concurrent medical condition.

Treatment and study plan

Andresen functional removable orthodontic appliance

Device

Included patients were treated for 24 months with a Functional removable orthodontic appliance, the Andresen activator. The initial checks were performed after 6 weeks with subsequent checks being carried out every 8th week, with the final follow-up at 24 months. The patient underwent functional treatment using the activator described in the protocol with midlines coincidence.

Other names: Andresen Activator

Primary outcomes

  1. TMJ disorder cessation

    Time frame: 24 months

    TMJ disorder and clinical mandibular symmetry was achieved or if mandibular growth was estimated as ceased.

Sponsors and collaborators

Lead sponsor

University of Messina

Other

Registry information

Official study title

Oral Health-Related Quality of Life in Patients With Juvenile Idiopathic Arthritis and Temporomandibular Joint Disorders Evaluation After Treatment With a Functional Appliance

Important dates

Study start
2004
Primary completion
2016
Study completion
2016
First posted
Jan 2, 2017
Registry last updated
Jan 2, 2017

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.