Primer Aligner Study

NCT ID: NCT02550938

Last Updated: 2021-02-03

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

253 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2020-09-30

Brief Summary

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To demonstrate that a primer aligner product can achieve similar results to the currently marketed product.

Detailed Description

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The Invisalign® System consists of a series of clear plastic aligners that are intended to replace conventional wire and bracket technology for many orthodontic cases. Each custom manufactured aligner exerts gentle, continuous forces to move teeth incrementally from their original state to a final, treated state. Each aligner is worn for about two weeks, then replaced by the next in the series until the final position is achieved. For years, orthodontists and dentists have used removable appliances for orthodontic treatment. Today, with the application of computer technology and custom manufacturing, Invisalign treats a broader range of cases with greater precision.

Conditions

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Malocclusion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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7 Aligner Cohort weartime 1

Seven Aligner cohort will change aligners at a designated interval Invisalign is the intervention.

Group Type EXPERIMENTAL

Invisalign

Intervention Type DEVICE

The Invisalign® System consists of a series of clear plastic aligners that are intended to replace conventional wire and bracket technology for many orthodontic cases. Each custom manufactured aligner exerts gentle, continuous forces to move teeth incrementally from their original state to a final, treated state. Each aligner is worn for a defined period of time , then replaced by the next in the series until the final position is achieved. For years, orthodontists and dentists have used removable appliances for orthodontic treatment. Today, with the application of computer technology and custom manufacturing, Invisalign treats a broader range of cases with greater precision.

7 Aligner Cohort weartime 2

Seven Aligner cohort will change aligners at a modified interval Invisalign is the intervention.

Group Type EXPERIMENTAL

Invisalign

Intervention Type DEVICE

The Invisalign® System consists of a series of clear plastic aligners that are intended to replace conventional wire and bracket technology for many orthodontic cases. Each custom manufactured aligner exerts gentle, continuous forces to move teeth incrementally from their original state to a final, treated state. Each aligner is worn for a defined period of time , then replaced by the next in the series until the final position is achieved. For years, orthodontists and dentists have used removable appliances for orthodontic treatment. Today, with the application of computer technology and custom manufacturing, Invisalign treats a broader range of cases with greater precision.

12 aligner cohort weartime 1

Twelve Aligner cohort will change aligners at a designated interval Invisalign is the intervention.

Group Type EXPERIMENTAL

Invisalign

Intervention Type DEVICE

The Invisalign® System consists of a series of clear plastic aligners that are intended to replace conventional wire and bracket technology for many orthodontic cases. Each custom manufactured aligner exerts gentle, continuous forces to move teeth incrementally from their original state to a final, treated state. Each aligner is worn for a defined period of time , then replaced by the next in the series until the final position is achieved. For years, orthodontists and dentists have used removable appliances for orthodontic treatment. Today, with the application of computer technology and custom manufacturing, Invisalign treats a broader range of cases with greater precision.

12 aligner cohort weartime 2

Twelve Aligner cohort will change aligners at a modified interval Invisalign is the intervention.

Group Type EXPERIMENTAL

Invisalign

Intervention Type DEVICE

The Invisalign® System consists of a series of clear plastic aligners that are intended to replace conventional wire and bracket technology for many orthodontic cases. Each custom manufactured aligner exerts gentle, continuous forces to move teeth incrementally from their original state to a final, treated state. Each aligner is worn for a defined period of time , then replaced by the next in the series until the final position is achieved. For years, orthodontists and dentists have used removable appliances for orthodontic treatment. Today, with the application of computer technology and custom manufacturing, Invisalign treats a broader range of cases with greater precision.

Interventions

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Invisalign

The Invisalign® System consists of a series of clear plastic aligners that are intended to replace conventional wire and bracket technology for many orthodontic cases. Each custom manufactured aligner exerts gentle, continuous forces to move teeth incrementally from their original state to a final, treated state. Each aligner is worn for a defined period of time , then replaced by the next in the series until the final position is achieved. For years, orthodontists and dentists have used removable appliances for orthodontic treatment. Today, with the application of computer technology and custom manufacturing, Invisalign treats a broader range of cases with greater precision.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Subject must have fully erupted dentition
* Age range ≥18 years old (Adult subject)
* Subjects who are indicated for either: 5, 7, 10, or 12 aligner sets

Exclusion Criteria

* Subject who has unerupted, erupting, partially erupted dentition (except for 2nd and 3rd molars)
* Subject who has mixed dentition
* Subject with periodontal disease
* Subject with active caries
* Subject with Temporomandibular Joint Disorders symptoms
* Subject has undergone pre-treatment with any orthodontic appliance 3 months prior to the start of treatment
* Subject has undergone any accelerated orthodontic treatment prior to or during treatment as part of this study
* Subject has known allergy to latex or plastic
* Subjects who are pregnant or will become pregnant during treatment
Minimum Eligible Age

18 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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Ahmed Moneim, DDS

Role: PRINCIPAL_INVESTIGATOR

Los Gatos Dental Center

Locations

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Wood Orthodontics

Anthem, Arizona, United States

Site Status

Cooke Orthodontics

Napa, California, United States

Site Status

The Orthodontic Center

Oakland, California, United States

Site Status

Green Dentistry

San Francisco, California, United States

Site Status

Align Technology, Inc.

San Jose, California, United States

Site Status

Posner, Henderson & Goslee Dentistry

Bristol, Connecticut, United States

Site Status

Feldman Orthodontics

Cheshire, Connecticut, United States

Site Status

Comizio Orthodontics

Eastchester, New York, United States

Site Status

Magic Touch Orthodontist

Little Neck, New York, United States

Site Status

Meadowbrook Dental Care

Mineola, New York, United States

Site Status

Wenger Orthodontics

Mayfield Heights, Ohio, United States

Site Status

Dental One Reston

Reston, Virginia, United States

Site Status

DMG Dental Design

Bothell, Washington, United States

Site Status

Anglia Orthdontics

Cambridge, England, United Kingdom

Site Status

Bluebell Dental Practice

Chigwell, England, United Kingdom

Site Status

Dream Smile Dental Clinic

London, England, United Kingdom

Site Status

High Street Dental Care

Melton Mowbray, Leicestershire, United Kingdom

Site Status

Brixworth Dental Practice

Brixworth, Northampton, United Kingdom

Site Status

Cherrybank Dental Spa

Edinburgh, Scotland, United Kingdom

Site Status

Countries

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United States United Kingdom

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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CSP-300307-00

Identifier Type: -

Identifier Source: org_study_id

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