OHRQoL Evaluation After Functional Therapy in JIA Patients

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03008681

Enrollment

Registered

2017-01-02

Start date

2004-01-31

Completion date

2016-10-31

Last updated

2017-01-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Juvenile Idiopathic Arthritis

Brief summary

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.

Detailed description

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.

Interventions

DEVICEAndresen functional removable orthodontic appliance

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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

8 Years to 20 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
TMJ disorder cessation	24 months	TMJ disorder and clinical mandibular symmetry was achieved or if mandibular growth was estimated as ceased.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026