NCT02087163

Brief Summary

The purpose of this study is to use clear aligners to measure tooth movement and length of treatment.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

February 28, 2014

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 14, 2014

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
23 days until next milestone

Results Posted

Study results publicly available

April 24, 2019

Completed
Last Updated

January 31, 2020

Status Verified

January 1, 2020

Enrollment Period

4.8 years

First QC Date

February 28, 2014

Results QC Date

January 8, 2019

Last Update Submit

January 17, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Tooth Movement Change

    Participants will be followed for the duration of orthodontic treatment, an expected average of 78 weeks. Tooth movement change will be measured as the number of millimeters of tooth movement per aligner.

    Baseline and end of treatment, an average of 78 weeks

Secondary Outcomes (1)

  • Length of Treatment Change

    Baseline and end of treatment, an average of 78 weeks

Study Arms (1)

Movement Enhancement Technique

EXPERIMENTAL

Movement Enhancement Technique Clear Aligner

Device: Movement Enhancement TechniqueDevice: Clear Aligner

Interventions

Conventional Orthodontic treatment

Movement Enhancement Technique

Orthodontic treatment with Clear Aligner

Movement Enhancement Technique

Eligibility Criteria

Age16 Years - 46 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Require Orthodontic Treatment
  • Have a permanent dentition
  • No craniofacial anomaly present
  • No past and present signs and symptoms of periodontal disease
  • No significant medical history or medication that would adversely affect the development or structure of the teeth and jaws and any subsequent tooth movement
  • No previous orthodontic or orthopaedic relapse
  • No history of trauma, bruxism or parafunction
  • years old, inclusive
  • No skeletal jaw discrepancy
  • Angle Class I or Class II molar and canine relationship
  • Crowding of at least 4mm per arch
  • No osteoporosis drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Align Technology, Inc.

San Jose, California, 95131, United States

Location

MeSH Terms

Conditions

Malocclusion

Interventions

Orthodontic Appliances, Removable

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Orthodontic AppliancesOrthodonticsDentistry

Results Point of Contact

Title
Allison Mossing
Organization
Align Technology

Study Officials

  • Chenin

    PRINCIPAL INVESTIGATOR
  • Kottemann

    PRINCIPAL INVESTIGATOR
  • Mariani

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2014

First Posted

March 14, 2014

Study Start

February 1, 2014

Primary Completion

December 1, 2018

Study Completion

April 1, 2019

Last Updated

January 31, 2020

Results First Posted

April 24, 2019

Record last verified: 2020-01

Locations