Primer Aligner Study

Align Technology

Status: Completed

Conditions: Malocclusion

Treatments: Device: Invisalign

Study type: Interventional

Funder types: Industry

Identifiers

NCT02550938

CSP-300307-00

Details and patient eligibility

About

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

Full 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.

Enrollment: 253 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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253 participants in 4 patient groups

7 Aligner Cohort weartime 1

Experimental group

Description:

Seven Aligner cohort will change aligners at a designated interval Invisalign is the intervention.

Treatment:

Device: Invisalign

7 Aligner Cohort weartime 2

Experimental group

Description:

Seven Aligner cohort will change aligners at a modified interval Invisalign is the intervention.

Treatment:

Device: Invisalign

12 aligner cohort weartime 1

Experimental group

Description:

Twelve Aligner cohort will change aligners at a designated interval Invisalign is the intervention.

Treatment:

Device: Invisalign

12 aligner cohort weartime 2

Experimental group

Description:

Twelve Aligner cohort will change aligners at a modified interval Invisalign is the intervention.

Treatment:

Device: Invisalign