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The Use of Clear Aligners With Movement Enhancement Techniques

Primary Purpose

Malocclusion

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Movement Enhancement Technique
Clear Aligner
Sponsored by
Align Technology, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malocclusion

Eligibility Criteria

16 Years - 46 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Align Technology, Inc.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Movement Enhancement Technique

Arm Description

Movement Enhancement Technique Clear Aligner

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
February 28, 2014
Last Updated
January 17, 2020
Sponsor
Align Technology, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02087163
Brief Title
The Use of Clear Aligners With Movement Enhancement Techniques
Official Title
The Use of Clear Aligners With Movement Enhancement Techniques
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
April 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Align Technology, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malocclusion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Movement Enhancement Technique
Arm Type
Experimental
Arm Description
Movement Enhancement Technique Clear Aligner
Intervention Type
Device
Intervention Name(s)
Movement Enhancement Technique
Intervention Description
Conventional Orthodontic treatment
Intervention Type
Device
Intervention Name(s)
Clear Aligner
Intervention Description
Orthodontic treatment with Clear Aligner
Primary Outcome Measure Information:
Title
Tooth Movement Change
Description
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.
Time Frame
Baseline and end of treatment, an average of 78 weeks
Secondary Outcome Measure Information:
Title
Length of Treatment Change
Description
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.
Time Frame
Baseline and end of treatment, an average of 78 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
46 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chenin
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kottemann
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mariani
Official's Role
Principal Investigator
Facility Information:
Facility Name
Align Technology, Inc.
City
San Jose
State/Province
California
ZIP/Postal Code
95131
Country
United States

12. IPD Sharing Statement

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The Use of Clear Aligners With Movement Enhancement Techniques

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