Evaluation of Clear Aligner Trays to Straighten Teeth

Solventum Orthodontics Corporation

Status: Completed

Conditions: Malocclusion

Treatments: Device: Clear Aligner

Study type: Interventional

Funder types: Industry

Identifiers

NCT03141788

US-05-013821/11-050005

Details and patient eligibility

About

The objective of this study is to evaluate the efficacy of Clear Aligners to correct tooth malocclusions with the use of attachments and/or buttons, as determined by the amount of teeth movement and overall achievement goals of the treatment plan.

Full description

This is a prospective, multi-center study with a maximum duration of 24 months or longer depending on refinements, to assess the safety and efficacy of 3M Clear Aligners, with the use of attachments to correct teeth malocclusions.

The subject population for this study will be male and female subjects ≥ 14 years of age. Subjects who meet the inclusion and exclusion criteria will be asked to participate in the study. Up to a total of 180 subjects may be enrolled at up to 12 different clinical research sites, (up to 15 subjects per site).

The subjects will undergo a target of up to 24 months (or longer depending on refinements) of treatment to align the teeth to the planned target. Subjects will wear the Clear Aligners for at least 22 hours per day, with the exception of consumption of meals and beverages, with the exception of water, which can be consumed while wearing the aligners. During each 6-week period between follow up visits, subjects will wear each set of Clear Aligners for 2 weeks, in the order indicated per the Orthodontists treatment plan.

Enrollment: 52 patients

Sex: All

Ages: 14+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Subject is at least 14 years of age.
2. Subject is willing and able to give informed consent.
3. Subject is willing to be digitally scanned at each 6-week visit, including after application of attachments.
4. Subject has a need for single or double arch orthodontic treatment with a target duration of 18 months or less.
5. Subject has good oral hygiene defined by the orthodontist.
6. Subject has only permanent dentition.

Exclusion criteria

1. Subject has skeletal discrepancies requiring surgery
2. Subject is undergoing active dental work
3. Subject has severe open bite > 2 mm
4. Subject has severe overjet > 4 mm
5. Subject has deep bite > 3 mm
6. Subject has over crowding per arch > 4 mm
7. Subject has dental prostheses/implants that will interfere with projected teeth movement
8. Subject is taking systemic steroid medication
9. Subject is taking Biphosphonates or any other medication for treatment of osteoporosis

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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52 participants in 1 patient group

3M Clear Aligner

Other group

Description:

Clear Aligner for Orthodontic Treatment

Treatment:

Device: Clear Aligner