NCT03141788

Evaluation of Clear Aligner Trays to Straighten Teeth

Evaluation of 3M Clear Aligner for Correction of Class I, II and III Malocclusion Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Solventum Orthodontics Corporation · Industry
• Sex: All
• Age: 14 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed 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.

Conditions

• Malocclusion

Interventions

Type	Name	Description
DEVICE	Clear Aligner	Clear Aligner used to straighten teeth to desired outcome

Timeline

• Start date: 2017-01-30
• Primary completion: 2019-10-09
• Completion: 2019-10-09
• First posted: 2017-05-05
• Last updated: 2024-12-02
• Results posted: 2020-11-04

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated device study