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Recruiting NCT06651944

Invisalign® System with Mandibular Advancement

No phase Interventional Class II Malocclusion Mandibular Advancement Mandibular Retrognathism Excessive Overjet

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Invisalign® System with mandibular advancement featuring occlusal blocks.
Who it may be relevant to
Registry conditions: Class II Malocclusion, Mandibular Advancement, Mandibular Retrognathism, Excessive Overjet. Basic parameters: 10 years — 16 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Invisalign® System with Mandibular Advancement Featuring Occlusal Blocks (MAOB) Post-Market Study

Overview

The goal of this clinical trial is to observe study participants' comfort and fit of their aligners with occlusal blocks, as well as evaluate the engagement of the blocks using the Invisalign® System with mandibular advancement featuring occlusal blocks

Interventions

  • Device Invisalign® System with mandibular advancement featuring occlusal blocks
    Class II correction using the Invisalign® System with mandibular advancement featuring occlusal blocks

Primary outcome measures

  • Comfort and fit [Time frame: Through the study completion of up to 2 years]
Secondary outcome measures (1)
  • Class II correction [Time frame: Through the study completion of up to 2 years]

Eligibility criteria

Inclusion criteria

  • Subject must be eligible for Invisalign treatment with mandibular advancement

Exclusion criteria

  • Subject's dentition not compatible with device or allergy to device materials
  • Subject who is pregnant, has active caries, periodontal disease, TMD, root resorption, has HAE (hereditary angioedema), has been diagnosed with epilepsy or any other seizure disorder

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Canada · 3 centers
  • Astra Orthodontics — Richmond
  • MacKenzie Orthodontics — Saint John
  • Discover Orthodontics — Brampton

Identifiers

NCT: NCT06651944 · A005541

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗