OHRQoL Evaluation After Functional Therapy in JIA Patients

Not Applicable

Completed

• Conditions: Juvenile Idiopathic Arthritis
• Interventions: Device: Andresen functional removable orthodontic appliance

• Registration Number: NCT03008681
• Lead Sponsor: University of Messina

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.

Study Timeline

• Study Start: 2004-01
• Primary Completion: 2016-09
• Study Completion: 2016-10
• Status Verified: 2016-12
• Study First Submitted: 2016-12-26
• Study First Submitted QC: 2016-12-29
• Last Update Submitted: 2016-12-29
• Study First Posted: 2017-01-02
• Last Update Posted: 2017-01-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 93

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Andresen functional removable orthodontic appliance	Andresen functional removable orthodontic appliance	All the enrolled patients was applied the Andresen Activator (a removable orthodontic appliance) 12-14 hours in a day in total. Functional appliances helped the movement of the teeth, with the achievement of good facial muscle function. All patients in the cohort were treated with the andresen actovator appliancev for deep bite and class II malocclusion correction. The appliances were individually manufactured of acrylic resin, with a central screw and a vestibular arch, fabricated through a wax bite registration; the patient was guided to close the mouth in mandibular protrusion with coincidence of the upper and lower midlines. The registration bite was very thin in order to obtain a minimum vertical dimension. The activator was modified every three months increasing its posterior vertical dimension in order to stimulate the mandibular ramus growth thanks to the dislocation of the mandibular condyle.

Primary Outcome Measures

Name	Time	Method
TMJ disorder cessation	24 months	TMJ disorder and clinical mandibular symmetry was achieved or if mandibular growth was estimated as ceased.

Trial Locations

Locations (1)

University of Messina; 🇮🇹 Messina, Italy