NCT03008681

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
93

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
12.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 26, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 2, 2017

Completed
Last Updated

January 2, 2017

Status Verified

December 1, 2016

Enrollment Period

12.7 years

First QC Date

December 26, 2016

Last Update Submit

December 29, 2016

Conditions

Juvenile Idiopathic Arthritis

Outcome Measures

Primary Outcomes (1)

  • TMJ disorder cessation

    TMJ disorder and clinical mandibular symmetry was achieved or if mandibular growth was estimated as ceased.

    24 months

Study Arms (1)

Andresen functional removable orthodontic appliance

EXPERIMENTAL

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

Interventions

Andresen functional removable orthodontic applianceDEVICE

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.

Also known as: Andresen Activator
Andresen functional removable orthodontic appliance

Eligibility Criteria

Age8 Years - 20 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • previous orthodontic treatment;
  • history of maxillofacial surgery;
  • genetic diseases, syndromes, other congenital deformities or any concurrent medical condition.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Messina

Messina, Italy, 98125, Italy

Location

Related Publications (1)

  • 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.

    PMID: 29878100DERIVED

MeSH Terms

Conditions

Arthritis, Juvenile

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Giovanni Matarese, DDS

    University of Messina

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
DDS. PhD

Study Record Dates

First Submitted

December 26, 2016

First Posted

January 2, 2017

Study Start

January 1, 2004

Primary Completion

September 1, 2016

Study Completion

October 1, 2016

Last Updated

January 2, 2017

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)