The Use of Clear Aligners With Movement Enhancement Techniques

Malocclusion Clinical Trial

Official title:

The Use of Clear Aligners With Movement Enhancement Techniques

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02087163
• Other study ID #: CSP-700007-00
• Status: Completed
• Phase: N/A
• Start date: February 2014
• Est. completion date: April 2019

Study information

• Verified date: January 2020
• Source: Align Technology, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: April 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 46 Years

Eligibility

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

Related Conditions & MeSH terms

• Malocclusion

Intervention

Device:
• Movement Enhancement Technique
Conventional Orthodontic treatment
• Clear Aligner
Orthodontic treatment with Clear Aligner

Locations

Country	Name	City	State
United States	Align Technology, Inc.	San Jose	California

Sponsors (1)

Lead Sponsor	Collaborator
Align Technology, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tooth Movement Change	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.	Baseline and end of treatment, an average of 78 weeks
Secondary	Length of Treatment Change	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.	Baseline and end of treatment, an average of 78 weeks