OHRQoL Evaluation After Functional Therapy in JIA Patients

December 29, 2016 updated by: Gaetano Isola, DDS, PhD, University of Messina

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

93

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Messina, Italy, 98125
        • University of Messina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 20 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.
Other Names:
  • Andresen Activator

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Messina

Investigators

  • Study Director: Giovanni Matarese, DDS, University of Messina

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2004

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

December 26, 2016

First Submitted That Met QC Criteria

December 29, 2016

First Posted (Estimate)

January 2, 2017

Study Record Updates

Last Update Posted (Estimate)

January 2, 2017

Last Update Submitted That Met QC Criteria

December 29, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010-918

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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