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Class II Correction Study Using the Invisalign System

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02376829
Recruitment Status : Active, not recruiting
First Posted : March 3, 2015
Last Update Posted : January 23, 2020
Sponsor:
Information provided by (Responsible Party):
Align Technology, Inc.

Tracking Information
First Submitted Date  ICMJE February 11, 2015
First Posted Date  ICMJE March 3, 2015
Last Update Posted Date January 23, 2020
Study Start Date  ICMJE March 2015
Estimated Primary Completion Date August 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 2, 2015)
Rate of tooth movement at the end of Class II correction. [ Time Frame: End of Class II Correction approximately 9 months to 1 year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 2, 2015)
  • Length of treatment time [ Time Frame: End of Treatment approximately 2 years ]
  • Patient quality of life questionnaire throughout treatment [ Time Frame: End of Treatment approximately 2 years ]
  • Doctor survey for satisfaction with treatment outcomes [ Time Frame: End of Treatment approximately 2 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Class II Correction Study Using the Invisalign System
Official Title  ICMJE Class II Correction Study Using the Invisalign System
Brief Summary To demonstrate that growing teenagers which present up to full cusp Class II malocclusions can be treated using the Invisalign System.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Malocclusion
Intervention  ICMJE Device: Invisalign System
The Invisalign® System is indicated for the alignment of teeth during orthodontic treatment of malocclusion
Study Arms  ICMJE Experimental: The Invisalign System
Class II correction of malocclusions
Intervention: Device: Invisalign System
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: December 6, 2017)
165
Original Estimated Enrollment  ICMJE
 (submitted: March 2, 2015)
110
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date August 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subject must have fully erupted dentition excluding 2nd and 3rd molars
  • Age range 11-19 years old
  • Subject that requires bilateral Class II correction and must require at least 3mm of correction as measured by first molar relationship

Exclusion Criteria:

  • Subject who has unerupted, erupting, partially erupted dentition (except for 2nd and 3rd molars)
  • Subject who has spaces between adjacent teeth larger than 3mm
  • Subject with active caries
  • Subject with periodontal disease
  • Subject does not have at least 1st molar fully captured in PVS (polyvinyl siloxane material ) impression or intraoral scan.
  • Subject with TMD (Temporomandibular joint dysfunction) symptoms
  • Subject has undergone pre-treatment with any orthodontic appliance (any previous treatment prior to study)
  • Subject has known allergy to latex and plastic
  • Subjects who are pregnant or will become pregnant during treatment
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 11 Years to 19 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02376829
Other Study ID Numbers  ICMJE MRF-002
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Align Technology, Inc.
Study Sponsor  ICMJE Align Technology, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Sherri Wilson-Lopes Align Technology, Inc.
PRS Account Align Technology, Inc.
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP