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OpenTrials
Completed

NCT Number: NCT02603289

One Week Aligner Evaluation

The purpose of this study is to demonstrate that changing aligners weekly provides similar results to changing aligners every two weeks.

Completed

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Key information

Conditions

Malocclusion Stomatognathic Diseases Tooth Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Dr. Bart Iwasiuk, Brampton, Ontario, 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. The aligners are designed to optimally move each tooth at a speed that follows physiologic principles. The purpose of this study is to demonstrate that changing aligners weekly provides similar results to changing aligners every two weeks.

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 except for 2nd and 3rd molars
  • For Teen treatment group, subjects ages <17 years of age
  • For Adult treatment group, subjects ≥17 years of age

Exclusion criteria

  • Subject has undergone any accelerated orthodontic treatment prior to or during treatment as part of this study
  • Subject with active caries
  • Subject with periodontal disease
  • Subject with TMD symptoms
  • Subject has known allergy to latex or plastic
  • Subjects who are pregnant or will become pregnant during treatment

Treatment and study plan

Invisalign

Device

Primary outcomes

  1. Planned to Final Tooth Position

    Time frame: Through study completion, an average of 2 years

    Test vs Historical Control Group

Secondary outcomes

  1. Treatment time

    Time frame: Through study completion, an average of 2 years

    Length of treatment

  2. Subject Quality of Life

    Time frame: Through study completion, an average of 2 years

    Assessment of QoL

Sponsors and collaborators

Lead sponsor

Align Technology, Inc.

Industry

Registry information

Important dates

Study start
2015
Primary completion
2018
Study completion
2020
First posted
Nov 11, 2015
Registry last updated
Oct 20, 2020

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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