The Use of Clear Aligners With Movement Enhancement Techniques

Not Applicable

Completed

• Conditions: Malocclusion

• Registration Number: NCT02087163
• Lead Sponsor: Align Technology, Inc.

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2014-02-28
• Study First Submitted QC: 2014-03-12
• Study First Posted: 2014-03-14
• Primary Completion: 2018-12
• Results First Submitted: 2019-01-08
• Study Completion: 2019-04
• Results First Submitted QC: 2019-04-03
• Results First Posted: 2019-04-24
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-17
• Last Update Posted: 2020-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Tooth Movement Change	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 Outcome Measures

Name	Time	Method
Length of Treatment Change	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.

Trial Locations

Locations (1)

Align Technology, Inc.; 🇺🇸 San Jose, California, United States