Mandibular Advancement Clear Aligner Treatment in Juvenile Idiopathic Arthritis Subjects

NCT05467579 | Unknown

• 1 other identifier: 072022
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Juvenile Idiopathic Arthritis; Malocclusion, Angle Class II

Outcome Measures

Primary Outcomes (5)

• Improvement of the facial profile

  Clinical evaluation in vivo (binary outcome yes/no)

  12 months

• Mandibular growth achievement

  Measured on CBCT scans (increase in mm of the mandibular length, superimposition of the 3D reconstruction of the condyles)

  12 months

• 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

• 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

• 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

Study Arms (2)

Healthy subjects

ACTIVE COMPARATOR

Healthy patients that will serve as controls will recruited having the same demographic characteristics of the experimental group i.e., age, sex, vertebral maturation stage and the same cranio-facial features, skeletal class II, class II division 1 malocclusion, mandibular retrognathia, normal/hyperdivergent growth pattern.

Device: Device: orthodontic - mandibular advancement clear aligner

JIA subjects

EXPERIMENTAL

Young people aged from 10 to 14 years old with skeletal class II, class II division 1 malocclusion, mandibular retrognathia, normal/hyperdivergent growth pattern, and affected by juvenile idiopathic arthritis

Device: Device: orthodontic - mandibular advancement clear aligner

Interventions

Device: orthodontic - mandibular advancement clear aligner DEVICE

Intervention orthodontic - mandibular advancement: mandibular retrognathia correction with a mandibular advancement using a step-wise approach with clear aligner.

Also known as: MA clear aligner; activator appliances

Healthy subjects; JIA subjects

Eligibility Criteria

• Age: 8 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may not qualify if:

• Previous orthodontic or orthopedic treatment with any type of intervention (to avoid confounding factors related to previous treatment)
• Patients with severe transverse dental or skeletal discrepancies
• Syndromes, orofacial cleft, or other special needs, except for Juvenile idiopathic arthritis
• Missing teeth (to avoid confounding factors related to anchorage loss due to the absence or early extraction of permanent teeth)
• Poor oral health that precludes orthodontic treatment (presence of caries, active white spots or periodontal diseases)

Sponsors & Collaborators

• University of Genova: lead
• University of Milan - Prof. Maspero Cinzia: collaborator
• University of Milan - Dr. Abate Andrea: collaborator

Study Sites (1)

Università di Milano, Ospedale maggiore Policlincio, IRCCS Cà Granda

Milan, Itali, 20100, Italy

Location

MeSH Terms

Conditions

Arthritis, Juvenile; Malocclusion, Angle Class II

Interventions

Activator Appliances

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Malocclusion; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Orthodontic Appliances, Functional; Orthodontic Appliances; Orthodontics; Dentistry; Orthodontic Appliances, Removable

Central Study Contacts

Alessandro Ugolini, DDS

CONTACT

3475971340; alessandro.ugolini@unige.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 14, 2022
• First Posted: July 20, 2022
• Study Start: October 1, 2022
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2025
• Last Updated: July 20, 2022

Record last verified: 2022-07

Locations

IT (1)