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Completed

NCT Number: NCT02376829

Class II Correction Study Using the Invisalign System

To demonstrate that growing teenagers which present up to full cusp Class II malocclusions can be treated using the Invisalign System.

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Key information

Conditions

Malocclusion Stomatognathic Diseases Tooth Diseases

Age range

11 year–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dr. Sam Daher, Vancouver, British Columbia, Canada

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About this study

The Invisalign® System consists of a series of clear plastic aligners that are intended to replace conventional wire and bracket technology for many orthodontic cases. Each custom manufactured aligner exerts gentle, continuous forces to move teeth incrementally from their original state to a final, treated state. Each aligner is worn for about two weeks, then replaced by the next in the series until the final position is achieved. For years, orthodontists and dentists have used removable appliances for orthodontic treatment. Today, with the application of computer technology and custom manufacturing, Invisalign treats a broader range of cases with greater precision.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subject must have fully erupted dentition excluding 2nd and 3rd molars
  • Age range 11-19 years old
  • Subject that requires bilateral Class II correction and must require at least 3mm of correction as measured by first molar relationship

Exclusion criteria

  • Subject who has unerupted, erupting, partially erupted dentition (except for 2nd and 3rd molars)
  • Subject who has spaces between adjacent teeth larger than 3mm
  • Subject with active caries
  • Subject with periodontal disease
  • Subject does not have at least 1st molar fully captured in PVS (polyvinyl siloxane material ) impression or intraoral scan.
  • Subject with TMD (Temporomandibular joint dysfunction) symptoms
  • Subject has undergone pre-treatment with any orthodontic appliance (any previous treatment prior to study)
  • Subject has known allergy to latex and plastic
  • Subjects who are pregnant or will become pregnant during treatment

Treatment and study plan

Invisalign System

Device

The Invisalign® System is indicated for the alignment of teeth during orthodontic treatment of malocclusion

Primary outcomes

  1. Rate of Tooth Movement at the End of Class II Correction.

    Time frame: End of Class II Correction up to 18 months

    The primary objective will be met through demonstrating that the velocity of Invisalign with MRF overjet correction is non-inferior to the published rates of Dynamax (0.42mm/month).

Secondary outcomes

  1. Length of Treatment Time

    Time frame: End of Treatment approximately 2 years

    This is the total treatment length of time that subjects took (in days) to complete Invisalign system treatment

  2. Patient Quality of Life Questionnaire Throughout Treatment

    Time frame: End of Treatment approximately 2 years

    As part of the secondary objective, subject perception was assessed through analysis of case report forms. Case report form analysis of the Quality of Life forms was conducted from the subjects in both the Clinical Study and Continued Access Clinical Study. Subjects were asked to rate their orthodontic experience throughout the course of the study, with options 1(very difficult), 2 (difficult), 3 (average), 4 (easy), and 5 (very easy) as the ratings.

  3. Doctor Survey for Satisfaction With Treatment Outcomes

    Time frame: End of Treatment approximately 2 years

    Doctors filled out a Doctor Survey with a scale rating of 1 (very difficult) to 5 (very easy) on how easy the product was to use and their satisfaction with the product. A higher score on the scale meant a better satisfaction experience .

Sponsors and collaborators

Lead sponsor

Align Technology, Inc.

Industry

Registry information

Important dates

Study start
2015
Primary completion
2021
Study completion
2021
First posted
Mar 3, 2015
Registry last updated
May 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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