Back to resultsOHRQoL Evaluation After Functional Therapy in JIA Patients
Primary Purpose
Juvenile Idiopathic Arthritis
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Andresen functional removable orthodontic appliance
Sponsored by
About this trial
This is an interventional supportive care trial for Juvenile Idiopathic Arthritis
Eligibility Criteria
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.
Sites / Locations
- University of Messina
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Andresen functional removable orthodontic appliance
Arm Description
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.
Outcomes
Primary Outcome Measures
TMJ disorder cessation
TMJ disorder and clinical mandibular symmetry was achieved or if mandibular growth was estimated as ceased.
Secondary Outcome Measures
Full Information
NCT ID
NCT03008681
First Posted
December 26, 2016
Last Updated
December 29, 2016
Sponsor
University of Messina
1. Study Identification
Unique Protocol Identification Number
NCT03008681
Brief Title
OHRQoL Evaluation After Functional Therapy in JIA Patients
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
October 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Messina
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Juvenile Idiopathic Arthritis
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
93 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Andresen functional removable orthodontic appliance
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Andresen functional removable orthodontic appliance
Other Intervention Name(s)
Andresen Activator
Intervention Description
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.
Primary Outcome Measure Information:
Title
TMJ disorder cessation
Description
TMJ disorder and clinical mandibular symmetry was achieved or if mandibular growth was estimated as ceased.
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giovanni Matarese, DDS
Organizational Affiliation
University of Messina
Official's Role
Study Director
Facility Information:
Facility Name
University of Messina
City
Messina
ZIP/Postal Code
98125
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29878100
Citation
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.
Results Reference
derived
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OHRQoL Evaluation After Functional Therapy in JIA Patients
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