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Completed

NCT Number: NCT02550938

Primer Aligner Study

To demonstrate that a primer aligner product can achieve similar results to the currently marketed product.

Completed

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Key information

Conditions

Malocclusion Stomatognathic Diseases Tooth Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Anglia Orthdontics, Cambridge, England, United Kingdom

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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
  • Age range ≥18 years old (Adult subject)
  • Subjects who are indicated for either: 5, 7, 10, or 12 aligner sets

Exclusion criteria

  • Subject who has unerupted, erupting, partially erupted dentition (except for 2nd and 3rd molars)
  • Subject who has mixed dentition
  • Subject with periodontal disease
  • Subject with active caries
  • Subject with Temporomandibular Joint Disorders symptoms
  • Subject has undergone pre-treatment with any orthodontic appliance 3 months prior to the start of treatment
  • Subject has undergone any accelerated orthodontic treatment prior to or during treatment as part of this study
  • Subject has known allergy to latex or plastic
  • Subjects who are pregnant or will become pregnant during treatment

Treatment and study plan

Invisalign

Device

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 a defined period of time , 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.

Primary outcomes

  1. Total Treatment Time

    Time frame: Approximately 1 year

    Total treatment time was measured in days. The less days a subject was in treatment, the better.

  2. Rate of Refinement

    Time frame: Approximately 1 year

    Rate of Refinement was how often subjects in each cohort required additional aligners in (in addition to their originally prescribed aligners) to treat the malocclusion. For example, if a subject was originally prescribed 20 aligners for treatment, but then needed 10 more aligners, the 10 extra aligners would be considered the "refinement." The Rate of Refinement for each cohort was measured as the total number of additional aligners required to complete orthodontic treatment divided by the total number of aligners that were initially prescribed to complete treatment, multiplied by 100. The smaller the rate of refinement (%), the better.

Other outcomes

  1. Subject Satisfaction.

    Time frame: Approximately 1 year

    (Observational, not used in data analysis). Subjects filled out a Quality of Life Survey with a scale rating of 1 (very difficult) to 5 (very easy) on how easy the product was to use and their orthodontic experience to date. A higher score on the scale meant a better outcome.

  2. Doctor Survey Results.

    Time frame: Approximately 1 year

    (Observational, not used in data analysis). 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 outcome.

Sponsors and collaborators

Lead sponsor

Align Technology, Inc.

Industry

Registry information

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Sep 16, 2015
Registry last updated
Feb 3, 2021

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

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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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