Clinical trial NCT02550938: Primer Aligner Study
Official title: Primer Aligner Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malocclusion
Lead sponsor: Align Technology, Inc.
Sponsor class: INDUSTRY
First posted: 2015-09-16
Enrollment: 253
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Total Treatment Time
timeFrame: Approximately 1 year
measure: Rate of Refinement
timeFrame: Approximately 1 year
Secondary outcomes:
Other outcomes:
measure: Subject Satisfaction.
timeFrame: Approximately 1 year
measure: Doctor Survey Results.
timeFrame: Approximately 1 year
Locations:
city: Anthem
country: United States
facility: Wood Orthodontics
state: Arizona
city: Napa
country: United States
facility: Cooke Orthodontics
state: California
city: Oakland
country: United States
facility: The Orthodontic Center
state: California
city: San Francisco
country: United States
facility: Green Dentistry
state: California
city: San Jose
country: United States
facility: Align Technology, Inc.
state: California
city: Bristol
country: United States
facility: Posner, Henderson & Goslee Dentistry
state: Connecticut
city: Cheshire
country: United States
facility: Feldman Orthodontics
state: Connecticut
city: Eastchester
country: United States
facility: Comizio Orthodontics
state: New York
city: Little Neck
country: United States
facility: Magic Touch Orthodontist
state: New York
city: Mineola
country: United States
facility: Meadowbrook Dental Care
state: New York
city: Mayfield Heights
country: United States
facility: Wenger Orthodontics
state: Ohio
city: Reston
country: United States
facility: Dental One Reston
state: Virginia
city: Bothell
country: United States
facility: DMG Dental Design
state: Washington
city: Cambridge
country: United Kingdom
facility: Anglia Orthdontics
state: England
city: Chigwell
country: United Kingdom
facility: Bluebell Dental Practice
state: England
city: London
country: United Kingdom
facility: Dream Smile Dental Clinic
state: England
city: Melton Mowbray
country: United Kingdom
facility: High Street Dental Care
state: Leicestershire
city: Brixworth
country: United Kingdom
facility: Brixworth Dental Practice
state: Northampton
city: Edinburgh
country: United Kingdom
facility: Cherrybank Dental Spa
state: Scotland
Study officials:
affiliation: Los Gatos Dental Center
name: Ahmed Moneim, DDS
role: PRINCIPAL_INVESTIGATOR
References: