Juvenile Idiopathic Arthritis Clinical Trial
Official title:
Short-term and Long-term Evaluation of Three-dimensional Morphological Condylar and Mandibular Changes in Patients Affected by Juvenile Idiopathic Arthritis Treated With Mandibular Advancement Clear Aligner. A Prospective Controlled Study
There is currently no information on how mandibular advancement therapy could influence three-dimensionally the condylar and mandibular morphology in growing patients affected by Juvenile Idiopathic Arthritis (JIA). Therefore, the aim is to assess the three-dimensional morphological mandibular changes produced by the Invisalign® Mandibular Advancement (MA) (Align Technology, San José, CA, USA) in growing subjects affected by juvenile idiopathic arthritis with unilateral and bilateral JIA and to compare them with not-JIA control subjects
Status | Not yet recruiting |
Enrollment | 50 |
Est. completion date | January 1, 2025 |
Est. primary completion date | January 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 8 Years to 14 Years |
Eligibility | 1. Aged from 10 to 14 years old and attending the Department of Biomedical Surgical and Dental Sciences, University of Milan at the peak of the pubertal spurt assessed using vertebral analysis. 2. Features of a class II, division 1 malocclusion with mandibular retrusion and ANB according to Riedel >4°. 3. Convex profile and minimum overjet of 4 mm in permanent dentition, without missing teeth 4. moderate crowding in the upper arch (=4 mm) 5. Parental informed consent Exclusion Criteria: 1. Previous orthodontic or orthopedic treatment with any type of intervention (to avoid confounding factors related to previous treatment) 2. Patients with severe transverse dental or skeletal discrepancies 3. Syndromes, orofacial cleft, or other special needs, except for Juvenile idiopathic arthritis 4. Missing teeth (to avoid confounding factors related to anchorage loss due to the absence or early extraction of permanent teeth) 5. Poor oral health that precludes orthodontic treatment (presence of caries, active white spots or periodontal diseases) |
Country | Name | City | State |
---|---|---|---|
Italy | Università di Milano, Ospedale maggiore Policlincio, IRCCS Cà Granda | Milan | Itali |
Lead Sponsor | Collaborator |
---|---|
University of Genova | University of Milan - Dr. Abate Andrea, University of Milan - Prof. Maspero Cinzia |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Improvement of the facial profile | Clinical evaluation in vivo (binary outcome yes/no) | 12 months | |
Primary | Mandibular growth achievement | Measured on CBCT scans (increase in mm of the mandibular length, superimposition of the 3D reconstruction of the condyles) | 12 months | |
Primary | Presence of inflammation during active phase of mandibular advancement | To monitoring TMJ inflammation during the active phase of treatment comparing the MRI taken before the beginning of therapy with those taken as controls every six months until the end of treatment and to evaluate patient's reported outcomes regarding treatment with mandibular advancement both in JIA and in the healthy control group | 12 months | |
Primary | Discomfort during active phase | Discomfort reported on a questionnaire during all the active phase of treatment recorded every 6 month (VAS scale, pain min-max 0-100) | 6 months | |
Primary | Discomfort during active phase | Discomfort reported on a questionnaire during all the active phase of treatment recorded every 6 month (VAS scale, pain min-max 0-100) | 12 months |
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