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Juvenile Idiopathic ArthritisNCT05467579

Mandibular Advancement Clear Aligner Treatment in Juvenile Idiopathic Arthritis Subjects

A study testing Device: orthodontic - mandibular advancement clear aligner in people with Juvenile Idiopathic Arthritis and Malocclusion, Angle Class II, run by University of Genova at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 8 to 14 years
What is being tested?
Device: orthodontic - mandibular advancement clear aligner
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteItaly
Study dates
1 Oct 2022to 1 Jan 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 8 to 14 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

None listed.

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

Alessandro Ugolini, DDS contact

3475971340

alessandro.ugolini@unige.it

Italy1 site
  • Università di Milano, Ospedale maggiore Policlincio, IRCCS Cà Granda

    Milan, Itali, 20100

    Andrea Abate, DDS, andreabate93@gmail.com

Other trials in Italy

About this study

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

Read the 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.

Being tested
Device: orthodontic - mandibular advancement clear aligner
Medical subject headings
Arthritis, Juvenile, Malocclusion, Angle Class II

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Device: orthodontic - mandibular advancement clear alignerDevice

    Also called MA clear aligner; activator appliances

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

Study groups in NCT05467579
Study groupRoleWhat they receive
Healthy subjectsActive comparatorHealthy 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.
Receives: Device: Device: orthodontic - mandibular advancement clear aligner
JIA subjectsExperimentalYoung 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
Receives: Device: Device: orthodontic - mandibular advancement clear aligner

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Improvement of the facial profile

    Clinical evaluation in vivo (binary outcome yes/no)

    Measured: 12 months

  2. Mandibular growth achievement

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

    Measured: 12 months

  3. 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

    Measured: 12 months

  4. 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)

    Measured: 6 months

  5. 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)

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jul 2022
  2. Study start1 Oct 2022 (estimated)
  3. Primary completion1 Jan 2024 (estimated)
  4. Study completion1 Jan 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05467579
Sponsor's protocol ID
072022
Status last verified
Jul 2022
First submitted
14 Jul 2022
Last updated
20 Jul 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Device: orthodontic - mandibular advancement clear aligner in people with Juvenile Idiopathic Arthritis and Malocclusion, Angle Class II, run by University of Genova at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 20 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Alessandro Ugolini, DDS (3475971340, alessandro.ugolini@unige.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Improvement of the facial profile (time frame: 12 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2022.

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