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.

Study Overview

• Status: Completed
• Conditions: Malocclusion
• Intervention / Treatment: Device: Movement Enhancement Technique; Device: Clear Aligner

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 Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Jose, California, United States, 95131
      • Align Technology, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 46 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Movement Enhancement Technique; Movement Enhancement Technique Clear Aligner	Device: Movement Enhancement Technique; Conventional Orthodontic treatment; Device: Clear Aligner; Orthodontic treatment with Clear Aligner

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Align Technology, Inc.
• Investigators: Principal Investigator: Chenin; Principal Investigator: Kottemann; Principal Investigator: Mariani

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Actual): December 1, 2018
• Study Completion (Actual): April 1, 2019

Study Registration Dates

• First Submitted: February 28, 2014
• First Submitted That Met QC Criteria: March 12, 2014
• First Posted (Estimate): March 14, 2014

Study Record Updates

• Last Update Posted (Actual): January 31, 2020
• Last Update Submitted That Met QC Criteria: January 17, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Malocclusion
• Other Study ID Numbers: CSP-700007-00