MalocclusionNCT02087163

The Use of Clear Aligners With Movement Enhancement Techniques

A study testing Movement Enhancement Technique and Clear Aligner in people with Malocclusion, run by Align Technology, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 16 to 46 yearsHealthy volunteers can take part
Conditions the study is for: Malocclusion
What is being tested?: Movement Enhancement Technique and Clear Aligner
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 90 participants
Where: 1 siteUnited States
Study dates: Feb 2014to Apr 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 16 to 46 years
All sexes
Healthy volunteers accepted
Child, Adult

Who may be able to join

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

Show all 12Show fewer

No history of trauma, bruxism or parafunction
16- 46 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

Who cannot join

Subjects who do not fulfill all inclusion criteria requirements

Trial locations and contacts

1 site in 1 country.

United States1 site

Align Technology, Inc.
San Jose, California, 95131

Other trials in United States

About this study

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

Read the detailed description

Orthodontic tooth movement is the result of a force applied to the crown of a tooth and the biological remodeling of the gum and bony tissues.

Conditions: Malocclusion
Being tested: Movement Enhancement Technique, Clear Aligner
Medical subject headings: Malocclusion

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Movement Enhancement TechniqueDevice
Conventional Orthodontic treatment
Clear AlignerDevice
Orthodontic treatment with Clear Aligner

Study groups in NCT02087163
Study group	Role	What they receive
Movement Enhancement Technique	Experimental	Movement Enhancement Technique Clear Aligner Receives: Device: Movement Enhancement Technique; Device: Clear Aligner

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline and end of treatment, an average of 78 weeks

Secondary outcomes (1)

Length of Treatment Change
Participants will be followed for the duration of orthodontic treatment, an expected average of 78 weeks. Length of treatment change will be measured as the number of weeks of movement per aligner.
Measured: Baseline and end of treatment, an average of 78 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2014Apr 2019

First posted14 Mar 2014 (estimated)
Study startFeb 2014
Primary completionDec 2018
Study completionApr 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for MalocclusionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 90 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02087163
Sponsor's protocol ID: CSP-700007-00
Status last verified: Jan 2020
First submitted: 28 Feb 2014
Last updated: 31 Jan 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Enrolling by invitation
Discision as Acceleration Method in Canine Retraction in Orthodontics With Aligner and Fixed Appliances in Young Adults a Split Mouth Study
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Assessment of the Locally Administrated Vitamin D3 and Corticision Efficacy on Orthodontic Canine Retraction
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Not yet recruiting
Timing, Trajectories and Prediction in Severe Dental Crowding: The Create SPACE (cSPACE)
Crowding of Teeth, Malocclusion; Displaced Teeth
Recruiting
FM Technique in Orthodontic Clear Aligner Therapy: A Single-Arm Clinical Study
Malocclusion
Not yet recruiting
Treatment of Mandibular Overjet in Children With Maxillary Retrognathism
Maxillary Retrognathism, Children

All Malocclusion trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Use of Clear Aligners With Movement Enhancement Techniques
ClinicalTrials.gov ID: NCT02087163
Acronym / sponsor ID: CSP-700007-00
Conditions: Malocclusion
Study type: Interventional
Recruitment status: Completed
Enrolment: 90 participants (actual)
Lead sponsor: Align Technology, Inc.Industry (pharma, biotech, devices)
Study start: Feb 2014
Primary completion: Dec 2018 (actual)
Study completion: Apr 2019 (actual)
First posted: 14 Mar 2014 (estimated)
Results: Posted 24 Apr 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Orthodontic tooth movement is the result of a force applied to the crown of a tooth and the biological remodeling of the gum and bony tissues.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Movement Enhancement Technique	Experimental	Device: Movement Enhancement Technique, Device: Clear AlignerMovement Enhancement Technique Clear Aligner

Who may qualify

Ages: 16 to 46 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult

Key inclusion criteria (12 listed)

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

Key exclusion criteria (1 listed)

Subjects who do not fulfill all inclusion criteria requirements

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Movement Enhancement TechniqueConventional Orthodontic treatment	Device	Movement Enhancement Technique
Clear AlignerOrthodontic treatment with Clear Aligner	Device	Movement Enhancement Technique

Primary outcome

Tooth Movement Change
Time frame: Baseline and end of treatment, an average of 78 weeks
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.

1 secondary outcome

Length of Treatment Change
Time frame: Baseline and end of treatment, an average of 78 weeks

Results and safety

Results posted to the registry on 24 Apr 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Movement Enhancement Technique	90	73

Primary outcome: Tooth Movement Change

Time frame: Baseline and end of treatment, an average of 78 weeks. Mean (95% Confidence Interval). Unit: millimeters

Measure	Movement Enhancement Technique n = 73
Value	0.363 (-0.22 to 0.45)

Population analysed: all completed subjects

1 secondary outcome is reported in the full results.

Adverse events

Time frame: baseline until end of treatment, an average of 78 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Movement Enhancement Technique	0 of 90 (0%)	0 of 90 (0%)	0 of 90

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Malocclusion

Enrolling by invitation
Discision as Acceleration Method in Canine Retraction in Orthodontics With Aligner and Fixed Appliances in Young Adults a Split Mouth Study
Bimaxillary Protrusion, Class II Div 1 Malocclusion
Recruiting
Assessment of the Locally Administrated Vitamin D3 and Corticision Efficacy on Orthodontic Canine Retraction
Malocclusions, Canine Retraction
Not yet recruiting
Timing, Trajectories and Prediction in Severe Dental Crowding: The Create SPACE (cSPACE)
Crowding of Teeth, Malocclusion; Displaced Teeth
Recruiting
FM Technique in Orthodontic Clear Aligner Therapy: A Single-Arm Clinical Study
Malocclusion
Not yet recruiting
Treatment of Mandibular Overjet in Children With Maxillary Retrognathism
Maxillary Retrognathism, Children

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Chenin principal investigator

Kottemann principal investigator

Mariani principal investigator

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Movement Enhancement Technique and Clear Aligner in people with Malocclusion, run by Align Technology, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Tooth Movement Change (time frame: Baseline and end of treatment, an average of 78 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02087163.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2020.