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One Week Aligner Evaluation

A

Align Technology

Status

Completed

Conditions

Malocclusion

Treatments

Device: Invisalign

Study type

Observational

Funder types

Industry

Identifiers

NCT02603289
CSP-300313-00

Details and patient eligibility

About

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

Full 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.

Enrollment

287 patients

Sex

All

Volunteers

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

Trial design

287 participants in 3 patient groups

Teen
Description:
\< 17 years of age
Treatment:
Device: Invisalign
Adult
Description:
17 years of age or older
Treatment:
Device: Invisalign
Adult with Primer Aligners
Description:
17 years of age or older This group will get Primer Aligners
Treatment:
Device: Invisalign

Trial contacts and locations

24

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Data sourced from clinicaltrials.gov

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