Primer Aligner Study

Malocclusion Clinical Trial

Official title:

Primer Aligner Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02550938
• Other study ID #: CSP-300307-00
• Status: Completed
• Phase: N/A
• Start date: May 2015
• Est. completion date: September 2020

Study information

• Verified date: January 2021
• Source: Align Technology, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 253
• Est. completion date: September 2020
• Est. primary completion date: September 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Malocclusion

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United Kingdom	Brixworth Dental Practice	Brixworth	Northampton
United Kingdom	Anglia Orthdontics	Cambridge	England
United Kingdom	Bluebell Dental Practice	Chigwell	England
United Kingdom	Cherrybank Dental Spa	Edinburgh	Scotland
United Kingdom	Dream Smile Dental Clinic	London	England
United Kingdom	High Street Dental Care	Melton Mowbray	Leicestershire
United States	Wood Orthodontics	Anthem	Arizona
United States	DMG Dental Design	Bothell	Washington
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	Wenger Orthodontics	Mayfield Heights	Ohio
United States	Meadowbrook Dental Care	Mineola	New York
United States	Cooke Orthodontics	Napa	California
United States	The Orthodontic Center	Oakland	California
United States	Dental One Reston	Reston	Virginia
United States	Green Dentistry	San Francisco	California
United States	Align Technology, Inc.	San Jose	California

Sponsors (1)

Lead Sponsor	Collaborator
Align Technology, Inc.

Countries where clinical trial is conducted

United States,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Subject Satisfaction.	(Observational, not used in data analysis). Subjects filled out a Quality of Life Survey with a scale rating of 1 (very difficult) to 5 (very easy) on how easy the product was to use and their orthodontic experience to date. A higher score on the scale meant a better outcome.	Approximately 1 year
Other	Doctor Survey Results.	(Observational, not used in data analysis). Doctors filled out a Doctor Survey with a scale rating of 1 (very difficult) to 5 (very easy) on how easy the product was to use and their satisfaction with the product. A higher score on the scale meant a better outcome.	Approximately 1 year
Primary	Total Treatment Time	Total treatment time was measured in days. The less days a subject was in treatment, the better.	Approximately 1 year
Primary	Rate of Refinement	Rate of Refinement was how often subjects in each cohort required additional aligners in (in addition to their originally prescribed aligners) to treat the malocclusion. For example, if a subject was originally prescribed 20 aligners for treatment, but then needed 10 more aligners, the 10 extra aligners would be considered the "refinement." The Rate of Refinement for each cohort was measured as the total number of additional aligners required to complete orthodontic treatment divided by the total number of aligners that were initially prescribed to complete treatment, multiplied by 100. The smaller the rate of refinement (%), the better.	Approximately 1 year