Primer Aligner Study



Status:Active, not recruiting
Conditions:Dental
Therapuetic Areas:Dental / Maxillofacial Surgery
Healthy:No
Age Range:18 - Any
Updated:10/25/2018
Start Date:May 2015
End Date:December 2019

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

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.

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
We found this trial at
14
sites
Mayfield Heights, Ohio 44124
Phone: 440-442-0916
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Mayfield Heights, OH
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41930 North Venture Drive
Anthem, Arizona 85086
Phone: 623-792-7323
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Anthem, AZ
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Bothell, Washington 98012
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Bothell, WA
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255 North Main Street
Bristol, Connecticut 06010
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Bristol, CT
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Cambridge, England CB3 9PA
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Cambridge,
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435 Highland Avenue
Cheshire, Connecticut 06410
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Cheshire, CT
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173 Fisher Avenue
Eastchester, New York 10709
Phone: 914-779-1444
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Eastchester, NY
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5515 Little Neck Parkway
Little Neck, New York 11362
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Little Neck, NY
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130 East Jericho Turnpike
Mineola, New York 11501
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Mineola, NY
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3392 Solano Avenue
Napa, California 94558
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Napa, CA
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Oakland, California 94612
Phone: 510-893-3117
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Oakland, CA
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Reston, Virginia 20191
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Reston, VA
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360 Post Street
San Francisco, California 94108
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San Francisco, CA
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San Jose, California 95131
Phone: 408-470-1032
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from
San Jose, CA
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