The Use of Clear Aligners With Movement Enhancement Techniques

NCT ID: NCT02087163

Last Updated: 2020-01-31

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2019-04-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Malocclusion

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Movement Enhancement Technique

Movement Enhancement Technique Clear Aligner

Group Type EXPERIMENTAL

Movement Enhancement Technique

Intervention Type DEVICE

Conventional Orthodontic treatment

Clear Aligner

Intervention Type DEVICE

Orthodontic treatment with Clear Aligner

Interventions

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Movement Enhancement Technique

Conventional Orthodontic treatment

Intervention Type DEVICE

Clear Aligner

Orthodontic treatment with Clear Aligner

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Maximum Eligible Age

46 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Align Technology, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chenin

Role: PRINCIPAL_INVESTIGATOR

Kottemann

Role: PRINCIPAL_INVESTIGATOR

Mariani

Role: PRINCIPAL_INVESTIGATOR

Locations

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Align Technology, Inc.

San Jose, California, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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CSP-700007-00

Identifier Type: -

Identifier Source: org_study_id

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