OHRQoL Evaluation After Functional Therapy in JIA Patients

NCT ID: NCT03008681

Last Updated: 2017-01-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 93 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-01-31
• Study Completion Date: 2016-10-31

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.

Conditions

Juvenile Idiopathic Arthritis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Andresen functional removable orthodontic appliance

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

Andresen Activator

Eligibility Criteria

Inclusion Criteria

• 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.

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Messina

OTHER

Sponsor Role: lead

Responsible Party

Gaetano Isola, DDS, PhD

DDS. PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Giovanni Matarese, DDS

Role: STUDY_DIRECTOR

University of Messina

Locations

University of Messina

Messina, Italy, Italy

Countries

Italy

References

Isola G, Perillo L, Migliorati M, Matarese M, Dalessandri D, Grassia V, Alibrandi A, Matarese G. The impact of temporomandibular joint arthritis on functional disability and global health in patients with juvenile idiopathic arthritis. Eur J Orthod. 2019 Mar 29;41(2):117-124. doi: 10.1093/ejo/cjy034.

Reference Type: DERIVED

PMID: 29878100 (View on PubMed)

Other Identifiers

2010-918

Identifier Type: -

Identifier Source: org_study_id