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Mandibular Advancement Clear Aligner Treatment in Juvenile Idiopathic Arthritis Subjects

Primary Purpose

Juvenile Idiopathic Arthritis, Malocclusion, Angle Class II

Status
Not yet recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Device: orthodontic - mandibular advancement clear aligner
Sponsored by
University of Genova
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Juvenile Idiopathic Arthritis

Eligibility Criteria

8 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers
  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)

Sites / Locations

  • Università di Milano, Ospedale maggiore Policlincio, IRCCS Cà Granda

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Healthy subjects

JIA subjects

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Improvement of the facial profile
Clinical evaluation in vivo (binary outcome yes/no)
Mandibular growth achievement
Measured on CBCT scans (increase in mm of the mandibular length, superimposition of the 3D reconstruction of the condyles)
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
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)
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)

Secondary Outcome Measures

Full Information

First Posted
July 14, 2022
Last Updated
July 19, 2022
Sponsor
University of Genova
Collaborators
University of Milan - Prof. Maspero Cinzia, University of Milan - Dr. Abate Andrea
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1. Study Identification

Unique Protocol Identification Number
NCT05467579
Brief Title
Mandibular Advancement Clear Aligner Treatment in Juvenile Idiopathic Arthritis Subjects
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2022 (Anticipated)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
January 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Genova
Collaborators
University of Milan - Prof. Maspero Cinzia, University of Milan - Dr. Abate Andrea

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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
Detailed Description
A wide range of functional appliances have been designed across the years to obtain a supplementary growth of the mandible by its forward posturing to correct mandibular retrusion. In a review published by Cozza et al., the efficiency of functional appliances used in healthy humans in terms of supplementary growth of the mandible per month of treatment, was measured. The Herbst appliance had the highest coefficient of efficiency (0.28 mm per month) followed by the Twin-block device (0.23 mm per month). Different authors claimed that functional treatment by removable appliances may be effective in treating Class II malocclusion with clinically relevant skeletal effects if performed during the pubertal growth phase. However, the growth pattern in JIA patients is more complicated and difficult compared to the treatment groups in the above-mentioned studies. The pattern is not only characterized by a decrease in mandibular length, but also by a decreased ratio between the posterior and the anterior face height, due to a failure in the vertical growth of the condyles The favorable effect of functional orthopedic appliances in JIA cases is therefore, besides advancing the mandible, an anterior (counter clockwise) rotation with a possible increase of the posterior face height, if possible. The efficacy of the functional orthopedic appliance in the correction of open bite has been demonstrated by Ibitayo et al. To date, different types of removable orthopedic appliances have been proposed into the scientific literature for management of deformities in skeletally immature patients with JIA, in particular the activator and the distraction splint. Although functional orthopedic treatment is recommended, literature is still lacking studies on this important topic. Recently a mandibular advancement device (MA) was implemented by Align TechnologyTM (San José, CA, USA) on clear aligners, for the treatment of skeletal Class II in growing patients. Similarly, to the principle applied in Twin Block, MA is composed by two pairs of lateral inclined planes (precision wings), positioned buccally in the posterior area of aligners, which come into contact each time the patient closes his mouth determining a mandibular forward position. Regarding the above-mentioned novel therapeutic approach, accurate bibliographic research performed on June 2022 showed that, the scientific literature needs further studies evaluating the skeletal effects produced by the Mandibular advancement with clear aligner since there is limited literature on its efficiency, consisting mostly of case studies. Recent longitudinal studies reported very promising results, when used in the pubertal growth phase. The short-term effects of Mandibular Advancement feature are dento-skeletal with additional growth of the mandible and improvement in facial convexity. The MA clear aligner treatment in JIA patients could bring countless benefits. The main ones are the possibility of performing a class II functional therapy with the same ability of a distraction splint or activators in promoting mandibular growth and at the same time controlling the vertical dimension with a programmed intrusion/extrusion of the teeth. Moreover, these therapeutic approaches should be more aesthetic, less bulky, and annoying appliances which can therefore guarantee greater collaboration from the patient. The latter would be reinforced by the fact that during functional therapy there would be a concomitant dental alignment with positive implications in patients whose facial aesthetics are already partially compromised, the face is one of the most salient and relevant social stimuli humans encounter and automatically evokes neural responses, facial deformity must not be underestimated. Moreover, clear aligner therapy is associated with minimal adverse events related to the periodontal structures compared to fixed appliances, this is of relevant interest in JIA subjects who often suffer from moderate or severe periodontitis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Juvenile Idiopathic Arthritis, Malocclusion, Angle Class II

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Non-Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Healthy subjects
Arm Type
Active Comparator
Arm Description
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.
Arm Title
JIA subjects
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Device: orthodontic - mandibular advancement clear aligner
Other Intervention Name(s)
MA clear aligner; activator appliances
Intervention Description
Intervention orthodontic - mandibular advancement: mandibular retrognathia correction with a mandibular advancement using a step-wise approach with clear aligner.
Primary Outcome Measure Information:
Title
Improvement of the facial profile
Description
Clinical evaluation in vivo (binary outcome yes/no)
Time Frame
12 months
Title
Mandibular growth achievement
Description
Measured on CBCT scans (increase in mm of the mandibular length, superimposition of the 3D reconstruction of the condyles)
Time Frame
12 months
Title
Presence of inflammation during active phase of mandibular advancement
Description
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
Time Frame
12 months
Title
Discomfort during active phase
Description
Discomfort reported on a questionnaire during all the active phase of treatment recorded every 6 month (VAS scale, pain min-max 0-100)
Time Frame
6 months
Title
Discomfort during active phase
Description
Discomfort reported on a questionnaire during all the active phase of treatment recorded every 6 month (VAS scale, pain min-max 0-100)
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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. Features of a class II, division 1 malocclusion with mandibular retrusion and ANB according to Riedel >4°. Convex profile and minimum overjet of 4 mm in permanent dentition, without missing teeth moderate crowding in the upper arch (≤4 mm) Parental informed consent Exclusion Criteria: 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alessandro Ugolini, DDS
Phone
3475971340
Email
alessandro.ugolini@unige.it
Facility Information:
Facility Name
Università di Milano, Ospedale maggiore Policlincio, IRCCS Cà Granda
City
Milan
State/Province
Itali
ZIP/Postal Code
20100
Country
Italy
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrea Abate, DDS
Email
andreabate93@gmail.com

12. IPD Sharing Statement

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Mandibular Advancement Clear Aligner Treatment in Juvenile Idiopathic Arthritis Subjects

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