Study Results
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View full resultsBasic Information
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COMPLETED
NA
253 participants
INTERVENTIONAL
2015-05-31
2020-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
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.
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.
7 Aligner Cohort weartime 2
Seven Aligner cohort will change aligners at a modified interval Invisalign is the intervention.
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.
12 aligner cohort weartime 1
Twelve Aligner cohort will change aligners at a designated interval Invisalign is the intervention.
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.
12 aligner cohort weartime 2
Twelve Aligner cohort will change aligners at a modified interval Invisalign is the intervention.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
Yes
Sponsors
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Align Technology, Inc.
INDUSTRY
Responsible Party
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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
Cooke Orthodontics
Napa, California, United States
The Orthodontic Center
Oakland, California, United States
Green Dentistry
San Francisco, California, United States
Align Technology, Inc.
San Jose, California, United States
Posner, Henderson & Goslee Dentistry
Bristol, Connecticut, United States
Feldman Orthodontics
Cheshire, Connecticut, United States
Comizio Orthodontics
Eastchester, New York, United States
Magic Touch Orthodontist
Little Neck, New York, United States
Meadowbrook Dental Care
Mineola, New York, United States
Wenger Orthodontics
Mayfield Heights, Ohio, United States
Dental One Reston
Reston, Virginia, United States
DMG Dental Design
Bothell, Washington, United States
Anglia Orthdontics
Cambridge, England, United Kingdom
Bluebell Dental Practice
Chigwell, England, United Kingdom
Dream Smile Dental Clinic
London, England, United Kingdom
High Street Dental Care
Melton Mowbray, Leicestershire, United Kingdom
Brixworth Dental Practice
Brixworth, Northampton, United Kingdom
Cherrybank Dental Spa
Edinburgh, Scotland, United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Other Identifiers
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CSP-300307-00
Identifier Type: -
Identifier Source: org_study_id
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