One Week Aligner Evaluation

NCT02603289 — Completed, 287 participants, Align Technology, Inc.

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RegistryNCT02603289
StatusCompleted
Study typeObservational
Enrollment287 (Actual)
SponsorAlign Technology, Inc. (Industry)
ConditionsMalocclusion
InterventionsInvisalign (Device)
Datesstart 2015-09-01, primary completion 2018-11-01, completion 2020-08-01, first posted 2015-11-11, last updated 2020-10-20
Locations24 sites in United States, Canada

Related Papers Related Patents Related Grants Related Experts
All trials for Malocclusion All trials of Invisalign

-Summary

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

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+Detailed description

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.

+Arms and interventions

ArmTypeInterventionsDescription
TeenDevice: Invisalign< 17 years of age
AdultDevice: Invisalign17 years of age or older
Adult with Primer AlignersDevice: Invisalign17 years of age or older This group will get Primer Aligners
  • Invisalign (Device)

+Outcome measures

Primary outcomes

  • Planned to Final Tooth Position [Through study completion, an average of 2 years]: Test vs Historical Control Group

Secondary outcomes

  • Treatment time [Through study completion, an average of 2 years]: Length of treatment
  • Subject Quality of Life [Through study completion, an average of 2 years]: Assessment of QoL

+Eligibility

Sex: All, accepts healthy volunteers

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

+Locations (24)

FacilityCityCountryStatus
Dr. Thomas MarcelLivermore, CaliforniaUnited States
Dr. Mary CookeNapa, CaliforniaUnited States
Dr. Bella Shen GarnettSan Francisco, CaliforniaUnited States
Align Technology, Inc.San Jose, CaliforniaUnited States
Dr. Robery Van den BergSan Ramon, CaliforniaUnited States
Dr. Anil IdicullaLone Tree, ColoradoUnited States
Dr. Ryan CaudillMerritt Island, FloridaUnited States
Dr. Sean HollidayPearl City, HawaiiUnited States
Dr. Jeff MastroianniGlen Carbon, IllinoisUnited States
Dr. Mark PerelmuterLouisville, KentuckyUnited States
Dr. James CrouseSalisbury, MarylandUnited States
Dr. Zvi KennetMacomb, MichiganUnited States
Dr. Thomas EverettBurnsville, MinnesotaUnited States
Dr. Justin WildEden Prairie, MinnesotaUnited States
Dr. Regina BlevinsInver Grove Heights, MinnesotaUnited States
Dr. William KottemannMaple Grove, MinnesotaUnited States
Dr. Vincent D'AscoliCarson City, NevadaUnited States
Dr. David CheninHenderson, NevadaUnited States
Dr. Carlyn PhucasMarlton, New JerseyUnited States
Dr. David PaquetteMooresville, North CarolinaUnited States
Dr. William GierieWilmington, North CarolinaUnited States
Dr. Brian AmyOklahoma City, OklahomaUnited States
Dr. Clark ColvilleSeguin, TexasUnited States
Dr. Bart IwasiukBrampton, OntarioCanada