OHRQoL Evaluation After Functional Therapy in JIA Patients

Juvenile Idiopathic Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03008681
• Other study ID #: 2010-918
• Status: Completed
• Phase: N/A
• First received: December 26, 2016
• Last updated: December 29, 2016
• Start date: January 2004
• Est. completion date: October 2016

Study information

• Verified date: December 2016
• Source: University of Messina
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: October 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 20 Years

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Juvenile
• Juvenile Idiopathic Arthritis
• Temporomandibular Joint Disorders

Intervention

Device:
• Andresen 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.

Locations

Country	Name	City	State
Italy	University of Messina	Messina

Sponsors (1)

Lead Sponsor	Collaborator
University of Messina

Country where clinical trial is conducted

Italy, 

Outcome

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