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OpenTrials
Completed

NCT Number: NCT02087163

The Use of Clear Aligners With Movement Enhancement Techniques

The purpose of this study is to use clear aligners to measure tooth movement and length of treatment.

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Key information

Conditions

Malocclusion Stomatognathic Diseases Tooth Diseases

Age range

16 year–46 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Align Technology, Inc.

San Jose, California, 95131, United States

About this study

Orthodontic tooth movement is the result of a force applied to the crown of a tooth and the biological remodeling of the gum and bony tissues.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Require Orthodontic Treatment
  • Have a permanent dentition
  • No craniofacial anomaly present
  • No past and present signs and symptoms of periodontal disease
  • No significant medical history or medication that would adversely affect the development or structure of the teeth and jaws and any subsequent tooth movement
  • No previous orthodontic or orthopaedic relapse
  • No history of trauma, bruxism or parafunction
  • 16- 46 years old, inclusive
  • No skeletal jaw discrepancy
  • Angle Class I or Class II molar and canine relationship
  • Crowding of at least 4mm per arch
  • No osteoporosis drugs

Exclusion criteria

  • Subjects who do not fulfill all inclusion criteria requirements

Treatment and study plan

Movement Enhancement Technique

Device

Conventional Orthodontic treatment

Clear aligner

Device

Orthodontic treatment with Clear Aligner

Primary outcomes

  1. Tooth Movement Change

    Time frame: Baseline and end of treatment, an average of 78 weeks

    Participants will be followed for the duration of orthodontic treatment, an expected average of 78 weeks. Tooth movement change will be measured as the number of millimeters of tooth movement per aligner.

Secondary outcomes

  1. Length of Treatment Change

    Time frame: Baseline and end of treatment, an average of 78 weeks

    Participants will be followed for the duration of orthodontic treatment, an expected average of 78 weeks. Length of treatment change will be measured as the number of weeks of movement per aligner.

Sponsors and collaborators

Lead sponsor

Align Technology, Inc.

Industry

Registry information

Important dates

Study start
2014
Primary completion
2018
Study completion
2019
First posted
Mar 14, 2014
Registry last updated
Jan 31, 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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